protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03224325 | 15.2 | Record Retention | 15.2 Record Retention The investigator agrees to keep the records stipulated in Section [15.1](#page-67-1) and those documents that include (but are not limited to) the study-specific documents, the identification log of all participating subjects, medical records, temporary media such as thermal sensitive paper, sourc... | [] |
NCT03224325 | 16.0 | REFERENCES | 16.0 REFERENCES - 1. Verrall L, Burnet PW, Betts JF, Harrison PJ. The neurobiology of D-amino acid oxidase and its involvement in schizophrenia. Mol Psychiatry 2010;15(2):122-37. - 2. Kakegawa W, Miyoshi Y, Hamase K, Matsuda S, Matsuda K, Kohda K, et al. D-serine regulates cerebellar LTD and motor coordination through ... | [] |
NCT03224325 | 17.0 | APPENDICES | 17.0 APPENDICES
Appendix A Responsibilities of the Investigator Clinical research studies sponsored by the sponsor are subject to ICH GCP and all the applicable local laws and regulations. The responsibilities imposed on investigators by the FDA are summarized in the "Statement of Investigator" (Form FDA 1572), which ... | [
"Appendix A Responsibilities of the Investigator",
"Appendix B Elements of the Subject Informed Consent",
"Appendix C Investigator Consent to the Use of Personal Information",
"Appendix D Pregnancy and Contraception Contraception and Pregnancy Avoidance Procedure",
"The following procedures apply for contra... |
NCT03228394 | 1.0 | BACKGROUND INFORMATION | 1.0 BACKGROUND INFORMATION | [] |
NCT03228394 | 1.1 | Postpartum Depression (PPD) | 1.1 Postpartum Depression (PPD) Postpartum depression (PPD) is a mood disorder that occurs in about 7% of women following the birth of a child.4 Common symptoms include feelings of extreme sadness, hopelessness, suicidal ideation, anxiety, and fatigue, which mirror those of a major depressive episode with the additiona... | [] |
NCT03228394 | 1.2 | Product Background and Clinical Information | 1.2 Product Background and Clinical Information Ganaxolone is the 3β-methylated synthetic analog of the progesterone metabolite allopregnanolone. Allopregnanolone exhibits potent anxiolytic, antidepressant, antiepileptic, and sedative activity by virtue of its GABAA receptor modulating properties. As with allopregnanol... | [] |
NCT03228394 | 1.2.1 | Ganaxolone Summary of Safety | 1.2.1 Ganaxolone Summary of Safety As of October 10, 2017, 1557 unique subjects have received ganaxolone ranging in duration from 1 day to more than 2 years using doses from 50 to 2000 mg/day in completed studies. Of these subjects, 1527 subjects received oral ganaxolone and 30 subjects received IV ganaxolone. CONFIDEN... | [] |
NCT03228394 | 1.2.1.1 | Summary of Adverse Events | 1.2.1.1 Summary of Adverse Events In clinical trials of ganaxolone, adverse events (AEs) related to the GABAergic mechanism of action in the CNS were reported more commonly in subjects receiving ganaxolone than placebo. In general, the frequency of these events has been dose related. Most of these effects were reported... | [] |
NCT03228394 | 1.2.1.2 | Summary of safety of IV ganaxolone | 1.2.1.2 Summary of safety of IV ganaxolone Preclinical studies and a study in 36 healthy volunteers assessing safety, pharmacokinetics and pharmacodynamics of intravenously administered ganaxolone has been completed. Preclinical toxicity studies showed intravenous (IV) ganaxolone to be generally safe and adverse events... | [] |
NCT03228394 | 1.2.1.3 | Other ganaxolone safety information | 1.2.1.3 Other ganaxolone safety information Ganaxolone is metabolized by CYP3A4/5, and in vitro data and human PK data from subjects taking strong CYP inducers (carbamazepine and phenytoin) has shown increased ganaxolone clearance with approximately a 45% lowering in overall ganaxolone levels and exposure. Marinus cons... | [] |
NCT03228394 | 1.2.1.4 | Preliminary safety information from the current trial (1042-PPD-2002) | 1.2.1.4 Preliminary safety information from the current trial (1042-PPD-2002)
Cohort 1 Dosing for the Cohort 1 of this study has been completed. In this cohort ganaxolone was infused at a rate of 4 mg/h for 48 hours after which the rate was lowered to 2 mg/h for the next 12 hours. The infusion was stopped at 60 hours.... | [
"Cohort 1",
"Cohort 2",
"Cohort 3"
] |
NCT03228394 | 2.0 | STUDY OBJECTIVES AND PURPOSE | 2.0 STUDY OBJECTIVES AND PURPOSE | [] |
NCT03228394 | 2.1 | Rationale for the Study | 2.1 Rationale for the Study Rapidly declining plasma levels of allopregnanolone and other neurosteroids, after childbirth are thought to be linked to triggering depression in women who are vulnerable to development of this condition. Ganaxolone, a synthetic analog of allopregnanolone, may provide benefit to these women... | [] |
NCT03228394 | 2.2 | Study Objectives | 2.2 Study Objectives | [] |
NCT03228394 | 2.2.1 | Safety Objective | 2.2.1 Safety Objective To assess the safety and tolerability of escalating doses of IV ganaxolone as determined by AEs and changes from baseline in laboratory measures, vital signs, Columbia Suicide Severity Rating Scale (CSSRS), electrocardiogram (ECG), Stanford Sleepiness Scale (SSS), and physical examination. In Coh... | [] |
NCT03228394 | 2.2.2 | Efficacy Objective | 2.2.2 Efficacy Objective To explore the efficacy of escalating doses of IV ganaxolone in the treatment of PPD with the 17-item Hamilton Depression Rating Scale (HAMD17), Edinburgh Postnatal Depression Scale (EPDS), Spielberger State-Trait Anxiety Inventory six item version (STAI6) and Clinical Global Impression-Improve... | [] |
NCT03228394 | 2.2.3 | Pharmacokinetic Objective | 2.2.3 Pharmacokinetic Objective To collect samples of blood for pharmacokinetic analysis to assess ganaxolone plasma exposure after administration of intravenous and oral ganaxolone. CONFIDENTIAL Page 20 of 104 | [] |
NCT03228394 | 3.0 | STUDY DESIGN | 3.0 STUDY DESIGN | [] |
NCT03228394 | 3.1 | Study Design and Study Population | 3.1 Study Design and Study Population This is a Phase 2A, double-blind, placebo-controlled, multiple-dose escalation study consisting of up to 6 cohorts (Cohorts 1-6). Approximately 200 women with PPD 18–45 years of age will be screened to randomize up to 100 subjects across up to 6 cohorts. Approximately 10-30 subject... | [] |
NCT03228394 | 3.2 | Rationale for Study Design | 3.2 Rationale for Study Design Rapid changes in allopregnanolone and other neurosteroid levels during and after pregnancy are thought to contribute to the biological underpinnings of PPD. There are also data suggesting that CONFIDENTIAL Page 21 of 104 the sensitivity of the GABA system is altered during pregnancy and a... | [] |
NCT03228394 | 3.3 | Blinding Scheme | 3.3 Blinding Scheme Within cohorts, subjects will be randomized to ganaxolone or placebo in a 1:1 ratio. The randomization scheme will be prepared by an independent third-party vendor. Treatment assignments will be obtained by the investigator (or designee) via an Interactive Voice and/or Web Response System (IxRS). Su... | [] |
NCT03228394 | 3.4 | Dose Selection | 3.4 Dose Selection | [] |
NCT03228394 | 3.4.1 | Cohort 1 | 3.4.1 Cohort 1 For Cohort 1, the targeted ganaxolone plasma concentration at steady state (Css) will be 52 ng/ml, which is estimated to be achieved with a ganaxolone infusion rate of 4 mg/hr (16 ml/h of ganaxolone 0.25 mg/ml solution). Steady state is expected to be achieved within 24 hours. For Cohort 1, the infusion ... | [] |
NCT03228394 | 3.4.2 | Cohort 2 | 3.4.2 Cohort 2 For Cohort 2, the ganaxolone infusion rate will be 8 mg/hr (16 ml/h of ganaxolone 0.5 mg/ml solution). The infusion rate will be lowered to 4 mg/h (8 ml/h of ganaxolone 0.5 mg/ml solution) after + 48 hours of infusion and will be stopped at + 60 hours. This is done to minimize any risks for withdrawal or... | [] |
NCT03228394 | 3.4.3 | Cohort 3 | 3.4.3 Cohort 3 For Cohort 3, an initial 12 mg bolus of ganaxolone will be given over 2 minutes, followed by ganaxolone infusion at a rate of 12 mg/h (24 ml/h of ganaxolone 0.5 mg/ml solution) for 48 hours. The rate will be reduced to 6 mg/h for the next 12 hours, which is done to minimize any risks for withdrawal or re... | [] |
NCT03228394 | 3.4.4 | Cohorts 4 and 5 | 3.4.4 Cohorts 4 and 5 Cohorts 4 and 5 are optional and will be utilized only if further dose exploration is warranted. Ganaxolone infusion rate will be decided based on the results from previous cohorts. However, no bolus doses higher than 16 mg over 2 minutes will be administered. The cap for the maximum infusion rate... | [] |
NCT03228394 | 3.4.5 | Cohort 6 | 3.4.5 Cohort 6 For Cohort 6, the goal of initiation of treatment with IV infusion followed by oral capsules is to maximize the speed of onset of antidepressant activity while providing the convenience of oral dosing for the remainder of the treatment period. Under this IV-oral dosing schedule there may not be a need fo... | [] |
NCT03228394 | 3.4.6 | Dose justification in context of previous experience with IV ganaxolone | 3.4.6 Dose justification in context of previous experience with IV ganaxolone In Study 1042-0405, which was a Phase 1 study in healthy volunteers investigating the safety of IV ganaxolone, infusion of 30 mg/h for 1 hour, 20 mg over 2 minutes and 20 mg/h for 4 hours led to peak concentrations of 258, 441 and 215 ng/mL, ... | [] |
NCT03228394 | 3.5 | Justification for Placebo as a Control Group | 3.5 Justification for Placebo as a Control Group There are no approved treatments for PPD although SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs) are commonly used off-label to manage PPD. All subjects whether randomized to the placebo or control group will be allowed to remain on their current anti... | [] |
NCT03228394 | 3.6 | Study Duration | 3.6 Study Duration The screening period for each cohort will be up to 2 weeks. In Cohorts 1-5 the screening period is followed by a 60-hour infusion treatment with or without initial bolus dosing during the 4-day inpatient treatment phase at a hospital or clinical pharmacology unit. The subjects will be discharged from... | [] |
NCT03228394 | 3.7 | Interim Analyses | 3.7 Interim Analyses The study team physician and the clinical operations lead will monitor emerging blinded safety data from each subject periodically throughout the duration of the study. In addition, safety and efficacy data from each cohort will be unblinded, and analyses will be conducted for the purpose of dose s... | [] |
NCT03228394 | 3.8 | Definition of Completion | 3.8 Definition of Completion A cohort is considered complete when the final subject in the cohort has completed the final protocol-defined assessment, including follow-up visits, for the cohort. The Study Completion Date is defined as the date the final subject, across all sites, completes her final protocol-defined as... | [] |
NCT03228394 | 3.9 | Sites and Regions | 3.9 Sites and Regions The study will be conducted in the United States at approximately 20 investigative sites. CONFIDENTIAL Page 26 of 104 | [] |
NCT03228394 | 4.0 | STUDY POPULATION | 4.0 STUDY POPULATION Each subject must participate in the informed consent process and provide written informed consent before any procedures specified in the protocol are performed. | [] |
NCT03228394 | 4.1 | Inclusion Criteria | 4.1 Inclusion Criteria The subject will not be considered eligible for the study without meeting all of the criteria below. - 1. An understanding of and ability, and willingness to fully comply with study procedures and restrictions. - 2. Ability to voluntarily provide written, signed, and dated informed consent as app... | [] |
NCT03228394 | 4.2 | Exclusion Criteria | 4.2 Exclusion Criteria Subjects are excluded from the study if any of the following exclusion criteria are met: - 1. Current or past history of any psychotic illness, including Major Depressive Episode with psychotic features - 2. Any psychiatric condition that, in the investigator's judgment, is considered clinically ... | [] |
NCT03228394 | 4.3 | Reproductive Potential | 4.3 Reproductive Potential | [] |
NCT03228394 | 4.3.1 | Female Contraception | 4.3.1 Female Contraception Sexually active females of childbearing potential should be using an acceptable form of contraception throughout the study period between screening and last follow-up visit. Acceptable methods of contraception are: - Intrauterine device plus condoms (If the subject has a hormone-releasing int... | [] |
NCT03228394 | 4.4 | Discontinuation of Subjects | 4.4 Discontinuation of Subjects A subject may withdraw from the study at any time for any reason without prejudice to their future medical care by the physician or at the institution. The investigator or sponsor may withdraw the subject at any time (e.g. in the interest of subject safety). The investigator is encourage... | [] |
NCT03228394 | 4.4.1 | Subject Withdrawal Criteria | 4.4.1 Subject Withdrawal Criteria All subjects reserve the right to withdraw from the clinical study at any time, as stated in the informed consent form (ICF). The Investigator may discontinue subjects from the clinical study for any of the following reasons: - 1. ECG evidence of QT prolongation (QTcF > 530 msec, or an... | [] |
NCT03228394 | 4.4.2 | Decisions to discontinue the study will be made at each participating site by the Principal Investigator. If feasible, the reason for discontinuation should be discussed with the Medical Monitor. Reasons for Discontinuation | 4.4.2 Decisions to discontinue the study will be made at each participating site by the Principal Investigator. If feasible, the reason for discontinuation should be discussed with the Medical Monitor. Reasons for Discontinuation The reason for withdrawal must be determined by the investigator and recorded in the subje... | [] |
NCT03228394 | 4.4.3 | Subjects "Lost to Follow-up" Prior to Last Scheduled Visit | 4.4.3 Subjects "Lost to Follow-up" Prior to Last Scheduled Visit A minimum of 3 documented attempts must be made to contact any subject lost to follow-up at any time point prior to the last scheduled contact (office visit or telephone contact). At least 1 of these documented attempts must include a written communicatio... | [] |
NCT03228394 | 5.0 | PRIOR AND CONCOMITANT TREATMENT | 5.0 PRIOR AND CONCOMITANT TREATMENT All non-study treatments (including herbal treatments, vitamins, and non-pharmacological treatments) received within 60 days prior to the screening visit (Visit 1) and through the final study contact (including protocol-defined follow-up period) must be recorded on the appropriate eC... | [] |
NCT03228394 | 5.1 | Prior Pharmacological Treatment | 5.1 Prior Pharmacological Treatment Prior pharmacological treatment includes all treatments (including herbal treatments and vitamins) that the subject received and stopped within 60 days of the date of the screening visit. For example, if the subject had been treated with sertraline during pregnancy but it was discont... | [] |
NCT03228394 | 5.2 | Concomitant Pharmacological Treatment | 5.2 Concomitant Pharmacological Treatment Concomitant treatment refers to all treatments (including herbal treatment and vitamins) taken between the screening visit and the end of the follow-up period regardless of the start date of the concomitant medication. For example, if the subject was started on a prenatal vitam... | [] |
NCT03228394 | 5.3 | Concomitant Psychological Treatment | 5.3 Concomitant Psychological Treatment Concomitant psychological treatment refers to all psychological care the subject is receiving between the screening visit and the end of the follow-up period regardless of the start date of the concomitant psychological treatment. Concomitant psychological treatment information m... | [] |
NCT03228394 | 5.3.1 | Permitted Treatment | 5.3.1 Permitted Treatment | [] |
NCT03228394 | 5.3.1.1 | Permitted Psychological Treatments | 5.3.1.1 Permitted Psychological Treatments The subject may continue their current form of psychological treatment (e.g. Cognitive Behavioral Therapy, Psychodynamic Psychotherapy, Supportive Psychotherapy) throughout the treatment period. However, initiation of a new therapy (a new treatment modality or switching a ther... | [] |
NCT03228394 | 5.3.1.2 | Permitted Antidepressant Treatments | 5.3.1.2 Permitted Antidepressant Treatments The subject may continue their current SSRI, SNRI or bupropion or other serotonin or norepinephrine modulating antidepressant (e.g. vortioxetine, mirtazapine) treatment provided the regimen conforms to the standard of care and the medication was started at least 21 days befor... | [] |
NCT03228394 | 5.3.1.3 | Other Permitted Treatments | 5.3.1.3 Other Permitted Treatments The subject may continue her current non-psychiatric medications with the exception of medications that are strong inducers or inhibitors of CYP3A4 (Appendix 1). The subject may use diphenhydramine 25 to 50 mg, trazodone 25 to 50 mg or doxepin 3 to 5 mg during the inpatient or outpati... | [] |
NCT03228394 | 5.3.2 | Prohibited Treatments | 5.3.2 Prohibited Treatments The following classes of medications and treatments are prohibited during the study treatment period. If the subject has been taking any of these medications before enrollment, there should be a medication-free period of a minimum of 5 days or 5 half-lives of that medication, whichever is lo... | [] |
NCT03228394 | 6.0 | INVESTIGATIONAL PRODUCT | 6.0 INVESTIGATIONAL PRODUCT | [] |
NCT03228394 | 6.1 | Identity of Investigational Product | 6.1 Identity of Investigational Product | [] |
NCT03228394 | 6.1.1 | Ganaxolone IV infusion solution | 6.1.1 Ganaxolone IV infusion solution Manufacturer: Particle Sciences Inc. Vehicle: Captisol® containing sterile IV solution Formulation: IV Strength: 3 mg/ml solution in a glass vial, which is to be diluted with 0.9% saline for the infusion. For details regarding preparation of the infusion solution please see pharmac... | [] |
NCT03228394 | 6.1.2 | Placebo IV control solution | 6.1.2 Placebo IV control solution Placebo name: 0.9% saline physiological sterile IV solution Formulation: IV solution matching ganaxolone in appearance Strength: not applicable Route of administration: IV | [] |
NCT03228394 | 6.1.3 | Ganaxolone oral capsules | 6.1.3 Ganaxolone oral capsules Ganaxolone capsules will be provided in size 00 white/opaque gelatin capsules packaged in HDPE bottles with a foil induction seal and child resistant closure. Each bottle will contain 70 capsules. Each capsule contains 225 mg ganaxolone (3α-hydroxy-3β-methyl-5α-pregnan-20 one), and hydrox... | [] |
NCT03228394 | 6.1.4 | Placebo oral capsules | 6.1.4 Placebo oral capsules Placebo formulation is comprised of sucrose spheres of comparable size to the ganaxolone spray layered spheres encapsulated in a size 00 white/opaque gelatin capsule. The weights of placebo capsules are matched to ganaxolone capsules. The placebo capsules will be provided to the sites in bot... | [] |
NCT03228394 | 6.2 | Administration of Investigational Product(s) | 6.2 Administration of Investigational Product(s) For administration of the IV investigational product (IP; ganaxolone or matching placebo [0.9% saline solution]) the investigator needs to use the Sponsor-approved Captisol®-compatible CONFIDENTIAL Page 34 of 104 intravenous infusion bags and infusion sets which are prep... | [] |
NCT03228394 | 6.2.1 | Interactive Voice/Web Response System (IxRS) Technology for Investigational Product Management | 6.2.1 Interactive Voice/Web Response System (IxRS) Technology for Investigational Product Management The name and address of the Interactive Voice/Web Response System (IxRS) for this study will be maintained in the Investigator's files at each study site. Interactive response technology will be used for the following i... | [] |
NCT03228394 | 6.2.2 | Allocation of Subjects to IP | 6.2.2 Allocation of Subjects to IP This is a double-blind, placebo-controlled study. The actual IP given to individual subjects is determined by a randomization schedule. prepared by an independent third-party vendor. Within cohorts, subjects will be randomized to ganaxolone or placebo in a 1:1 ratio Subject numbers ar... | [] |
NCT03228394 | 6.2.3 | Dosing | 6.2.3 Dosing Subjects entering the study will be randomized to ganaxolone or matching placebo at the Baseline Visit. The goal of Cohorts 1-6 is to determine safety, tolerability, PK and efficacy of the IV formulation (and in Cohort 6, the IV formulation followed by oral formulation) of ganaxolone in PPD subjects admini... | [
"Cohort 2",
"Cohort 3",
"Cohort 4 and 5",
"Cohort 6"
] |
NCT03228394 | 6.2.4 | Dose Adjustments | 6.2.4 Dose Adjustments Sedation and dizziness are known effects of ganaxolone at higher doses. If a subject experiences excessive sedation or dizziness the investigator may adjust the dosing by stopping the infusion for a minimum of 1 hour or until the effects resolve and then restarting the dosing at half the rate pre... | [] |
NCT03228394 | 6.2.5 | Blinding | 6.2.5 Blinding The site pharmacy personnel who dispenses the study drug will not be blinded and will not be involved in any study assessments. All other participating staff involved in the evaluation and execution of the study will remain blinded to subject's study drug treatment. | [] |
NCT03228394 | 6.2.6 | Unblinding the Treatment Assignment | 6.2.6 Unblinding the Treatment Assignment The treatment assignment must not be broken during the study except in emergency situations in which the identification of the investigational product is required for further treatment of the subject. The investigator should contact the medical monitor before unblinding, if pos... | [] |
NCT03228394 | 6.3 | Labeling, Packaging, Storage, and Handling | 6.3 Labeling, Packaging, Storage, and Handling Further information regarding labeling, packaging, storage and handling can be found in the Pharmacy Manual. | [] |
NCT03228394 | 6.3.1 | Labeling | 6.3.1 Labeling Each stock solution vial contains 88 mL of ganaxolone at a concentration of 3 mg/mL. A label is applied to each vial with information on strength, manufacturing batch number, manufacturing date, storage conditions, name of the manufacturer, and a warning that the drug is intended for research only. The s... | [] |
NCT03228394 | 6.3.2 | Packaging | 6.3.2 Packaging | [] |
NCT03228394 | 6.3.2.1 | IV ganaxolone | 6.3.2.1 IV ganaxolone The sponsor will provide stock study drug solution which will be diluted by an unblinded research pharmacist at the investigative site. The sponsor will also provide or approve IV bags and empty syringes which are to be used for infusion and bolus dosing of the study drug and placebo. All packagin... | [] |
NCT03228394 | 6.3.2.2 | Ganaxolone and placebo oral capsules | 6.3.2.2 Ganaxolone and placebo oral capsules For Cohort 6 ganaxolone capsules and matching placebos will be provided in HDPE bottles. All packaging and labeling operations will be performed according to good manufacturing practice (GMP) and good clinical practice (GCP) guidelines. Investigational products are prepared ... | [] |
NCT03228394 | 6.3.3 | Storage | 6.3.3 Storage The investigator has overall responsibility for ensuring that investigational product is stored in a secure, limited-access location. Limited responsibility may be delegated to the pharmacist, but this delegation must be documented. The ganaxolone stock solution investigational product will be stored at r... | [] |
NCT03228394 | 6.4 | Drug Accountability | 6.4 Drug Accountability Drug kits containing the study drug (ganaxolone stock vials for the IV solution, ganaxolone 225 mg capsules and matching placebo capsules) and supplies needed for each subject for the entire study will be supplied to the investigative site by the sponsor or a distributor on behalf of the sponsor... | [] |
NCT03228394 | 6.5 | Drug Administration | 6.5 Drug Administration | [] |
NCT03228394 | 6.5.1 | Administration of IV IP (Cohorts 1-6) | 6.5.1 Administration of IV IP (Cohorts 1-6) The IP will be administered IV via an indwelling catheter inserted in a vein on the arm or hand. The IP should be given as continuous infusion as instructed. If the study drug is stopped temporarily (e.g. catheter change) the infusion may be re-started at the same rate as bef... | [] |
NCT03228394 | 6.5.2 | Administration of oral ganaxolone or placebo capsules (Cohort 6) | 6.5.2 Administration of oral ganaxolone or placebo capsules (Cohort 6) Oral doses of ganaxolone or matching placebo should be taken at dinner time with fatty food (±15 minutes of a fatty meal or snack, e.g., fatty yogurt, nuts, avocado) and with 240 mL (8 oz) of water at home. Subjects participating in Cohort 6 will be... | [] |
NCT03228394 | 7.0 | STUDY PROCEDURES | 7.0 STUDY PROCEDURES This is a Phase 2A, double-blind, placebo-controlled, multiple-dose escalation study consisting of up to 6 cohorts. In Cohorts 1-5 the IV formulation of ganaxolone will be used while in Cohort 6 both IV and oral formulations will be used. Approximately 200 women with PPD 18 to 45 years of age will ... | [] |
NCT03228394 | 7.1 | Screening Visit and Screening Period (day -14 to -1) – Cohorts 1-6 | 7.1 Screening Visit and Screening Period (day -14 to -1) – Cohorts 1-6 - Obtain written informed consent - Collect demographics, medical history, review prior medications, review of concomitant medications and therapies, - Assess CGI-S - Conduct MINI international neuropsychiatric interview - Conduct Hamilton Depressio... | [] |
NCT03228394 | 7.2 | Admission to the Unit (Day 0) – Cohorts 1-6 | 7.2 Admission to the Unit (Day 0) – Cohorts 1-6 - Review concomitant medications and therapies - Admission to the unit. The subject arrives on the unit the day before the start of the infusion (Day 1) to complete assessments and accommodate to the unit. - Collect vital signs (BP, pulse, temperature, pulse oximetry, res... | [] |
NCT03228394 | 7.3 | Infusion Days (+ 1 to + 4) – Cohorts 1-5 | 7.3 Infusion Days (+ 1 to + 4) – Cohorts 1-5 | [] |
NCT03228394 | 7.3.1 | Before Infusion (Morning of Day + 1) | 7.3.1 Before Infusion (Morning of Day + 1) - Review concomitant medications - CTNI to conduct HAMD17 interview - EPDS CONFIDENTIAL Page 43 of 104 - STAI6 - Assess CGI-S - Collect AEs - Collect vital signs (BP, pulse, temperature, pulse oximetry, respiratory rate) - Stanford Sleepiness Scale (SSS) - Conduct CSSRS interv... | [] |
NCT03228394 | 7.3.2 | During Infusion (Days +1 to +4) | 7.3.2 During Infusion (Days +1 to +4) - Start bolus/infusion in the morning of Day +1 (0h) after baseline assessments are completed - CTNI to conduct interviews for HAMD17 (+12h, +24h, +48h, +60h, +72h) - Conduct interviews for CGI-I (+12h, +24h, +48h, +60h, +72h) - EPDS (+60h) - STAI6 (+12h, +24h, +48h, +60h, +72h) - ... | [] |
NCT03228394 | 7.4 | Post Discharge Follow-up Period (Days +5 to +30) – Cohorts 1-5 | 7.4 Post Discharge Follow-up Period (Days +5 to +30) – Cohorts 1-5 | [] |
NCT03228394 | 7.4.1 | First Post-discharge Visit 7 Days After Discharge from the Unit (Day +11; visit window) | 7.4.1 First Post-discharge Visit 7 Days After Discharge from the Unit (Day +11; visit window) - Review concomitant medications and therapies - Collect vital signs (BP, pulse, temperature, pulse oximetry, respiratory rate) - Collect safety laboratory tests. - Collect neurosteroid level - Collect pharmacokinetic sample -... | [] |
NCT03228394 | 7.4.2 | Second Post-discharge Visit 30 Days After Discharge From the Unit (Day +34) | 7.4.2 Second Post-discharge Visit 30 Days After Discharge From the Unit (Day +34) - Review concomitant medications and therapies - Collect vital signs (BP, pulse, temperature, pulse oximetry, respiratory rate) - Measure weight - Collect urine sample for urinalysis, drug screen and urine pregnancy test, - Collect pharma... | [
"Specific timepoints for assessments on days +1, +2, +3 and +4: - Cohorts 1-5"
] |
NCT03228394 | 7.5 | Infusion (Day +1) – Cohort 6 (Screening and Admission visits for Cohort 6 described in Section 7.1 and 7.2, respectively) | 7.5 Infusion (Day +1) – Cohort 6 (Screening and Admission visits for Cohort 6 described in Section 7.1 and 7.2, respectively) | [] |
NCT03228394 | 7.5.1 | Before Infusion (Morning of Day +1; Baseline) | 7.5.1 Before Infusion (Morning of Day +1; Baseline) - CTNI to conduct HAMD17 interview - EPDS - STAI6 - Assess CGI-S - Review concomitant medications - Collect vital signs (BP, pulse, temperature, pulse oximetry, respiratory rate), - Stanford Sleepiness Scale (SSS) - Conduct CSSRS interview - Collect AEs - Randomizatio... | [] |
NCT03228394 | 7.5.2 | During the Infusion and Evening of Day +1 (Day +1) | 7.5.2 During the Infusion and Evening of Day +1 (Day +1) - Start 6-hour infusion at 40 mL/hr at 9 am of Day +1 (0h) after baseline assessments are completed (listed above) - End 6-hour infusion - Complete +6h assessments after the end of the 6-hour infusion CTNI to conduct interviews for HAMD17 (+6h) - Conduct intervie... | [] |
NCT03228394 | 7.5.3 | Day + 2 (Discharge and transition to outpatient treatment) | 7.5.3 Day + 2 (Discharge and transition to outpatient treatment) - The assessments listed below are completed before discharge - CTNI to conduct interviews for HAMD17 - Conduct interviews for CGI-I - EPDS - STAI6 - Collect AEs - Collect ECG - Collect VS (BP, pulse, respiratory rate, pulse oximetry, temperature) - Colle... | [] |
NCT03228394 | 7.6 | Outpatient treatment phase (Days + 3 – +29) - Cohort 6 | 7.6 Outpatient treatment phase (Days + 3 – +29) - Cohort 6 | [] |
NCT03228394 | 7.6.1 | Safety phone calls (Days +3, +5, +10 and +13) | 7.6.1 Safety phone calls (Days +3, +5, +10 and +13) • A safety phone call is made on days +3, +5, +10, and +13 by the PI (or the sub-I). The subject is asked about her general wellbeing. AEs are recorded. | [] |
NCT03228394 | 7.6.2 | Visit 3 HAMD Call (Day +4 ±1 day) | 7.6.2 Visit 3 HAMD Call (Day +4 ±1 day) • CTNI to conduct HAMD17 interview CONFIDENTIAL Page 49 of 104 | [] |
NCT03228394 | 7.6.3 | Visit 4 (Day +8) | 7.6.3 Visit 4 (Day +8) - CTNI to conduct HAMD17 interview - EPDS - STAI6 - Assess CGI-I - Review concomitant medications and therapies - Collect vital signs (BP, pulse, temperature, pulse oximetry, respiratory rate), - Collect ECG - Collect urine sample for urinalysis, drug screen and urine pregnancy test - Collect saf... | [] |
NCT03228394 | 7.6.4 | Visit 5 HAMD Call (Day +11 ±1 day) | 7.6.4 Visit 5 HAMD Call (Day +11 ±1 day) • CTNI to conduct HAMD17 interview | [] |
NCT03228394 | 7.6.5 | Visit 6 (Day +15 ±2 days) | 7.6.5 Visit 6 (Day +15 ±2 days) - CTNI to conduct HAMD17 interview - EPDS - STAI6 - Assess CGI-I - Review concomitant medications and therapies - Collect vital signs (BP, pulse, temperature, pulse oximetry, respiratory rate), • Collect ECG CONFIDENTIAL Page 50 of 104 - Collect urine sample for urinalysis, drug screen a... | [] |
NCT03228394 | 7.6.6 | Visit 7 (Day +22 ±3 days) | 7.6.6 Visit 7 (Day +22 ±3 days) - CTNI to conduct HAMD17 interview - EPDS - STAI6 - Assess CGI-I - Review concomitant medications and therapies - Collect vital signs (BP, pulse, temperature, pulse oximetry, respiratory rate), - Collect ECG - Collect urine sample for urinalysis, drug screen and urine pregnancy test - Co... | [] |
NCT03228394 | 7.6.7 | Visit 8 (Day +29 ±3 days) | 7.6.7 Visit 8 (Day +29 ±3 days) • CTNI to conduct HAMD17 interview CONFIDENTIAL Page 51 of 104 - EPDS - STAI6 - Assess CGI-I - Review concomitant medications and therapies - Collect vital signs (BP, pulse, temperature, pulse oximetry, respiratory rate), - Collect ECG - Collect urine sample for urinalysis, drug screen a... | [] |
NCT03228394 | 7.7 | Post–treatment Follow-up Period (Days +29 to +71) – Cohort 6 | 7.7 Post–treatment Follow-up Period (Days +29 to +71) – Cohort 6 | [] |
NCT03228394 | 7.7.1 | First Post-treatment Follow-up Visit - 7 days After the Last On-treatment Visit (Day +36) | 7.7.1 First Post-treatment Follow-up Visit - 7 days After the Last On-treatment Visit (Day +36) - The Follow-up Visit 1 should occur about 1 week after the Day 29 visit. - CTNI to conduct interviews for HAMD17 - Perform EPDS - Perform STAI6 - Assess CGI-I - Review concomitant medications and therapies - Collect vital s... | [] |
NCT03228394 | 7.7.2 | Second Post-treatment Follow-up Visit - 28 days After the Last Ontreatment Visit (Day +57) | 7.7.2 Second Post-treatment Follow-up Visit - 28 days After the Last Ontreatment Visit (Day +57) - The Follow-up Visit 2 should occur about 28 days after the Day 29 visit. - CTNI to conduct interviews for HAMD17 - Perform EPDS - Perform STAI6 - Assess CGI-I - Review concomitant medications and therapies - Collect vital... | [] |
NCT03228394 | 7.7.3 | Third Post-treatment Follow-up Visit - 42 days After the Last On-treatment Visit (Day +71) | 7.7.3 Third Post-treatment Follow-up Visit - 42 days After the Last On-treatment Visit (Day +71) - The Follow-up Visit 3 should occur about 42 days after the Day 29 visit. - CTNI to conduct interviews for HAMD17 - Perform EPDS - Perform STAI6 - Assess CGI-I - Review concomitant medications and therapies - Collect vital... | [] |
NCT03228394 | 7.8 | Study Evaluations and Procedures | 7.8 Study Evaluations and Procedures | [] |
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