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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001556-21 | EudraCT Number |
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An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia
This is a 26 week, multiregional, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 for the treatment of subjects with schizophrenia who have completed the 4 week double-blind treatment phase of Study SEP361-201 (NCT02969382) Subjects received open-label SEP-363856 50 mg/day from Day 1 through Day 3, and then received flexible dosing of SEP-363856 (25, 50, or 75 mg/day) for the rest of the trial.
No statistical hypothesis tests will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEP-363856 | Experimental | SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEP-363856 | Drug | One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation | Number of Participants with overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation | From first dose of study drug to last study visit (27 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS) | Number of participants with suicidal ideation (SI) and suicidal behavior (SB) using the Columbia - Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior. |
Not provided
Inclusion Criteria:
Subject must give written informed consent and privacy authorization prior to participation in the study and able to comply with the protocol, in the opinion of the investigator.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International research Group | Little Rock | Arkansas | 72211 | United States | ||
| CNRI-Los Angeles, LLC |
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Subjects received open-label SEP-363856 50 mg/day from Day 1 through Day 3, and then received flexible dosing of SEP-363856 (25, 50, or 75 mg/day) for the rest of the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | SEP-363856 | SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 13, 2017 | Nov 30, 2021 |
Not provided
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| Overall post Open-label Baseline treatment period (26 weeks) |
| Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior. | Overall post Open-label Baseline treatment period (26 weeks) |
| Time to Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856 | Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others. | From the time of clinical response to relapse or censor (one day after the last study drug dose) |
| Rate of Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856 | Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others. | From the time of clinical response to relapse or censor (one day after the last study drug dose) |
| Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology) | PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. | Double-blind Baseline (DB BLN), Open-label Baseline (OL BLN), Week 26 (Wk 26) |
| Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) Score | The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity. | Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26 |
| Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total Score | The BNSS is a rating scale to measure the current level of severity of negative symptoms in schizophrenia and schizoaffective disorder. The measure is comprised of 13 individual items organized in 6 subscales. The 13 individual items provide a composite total score (ranging from 0 to 78). Each of the items are scored on a Likert-type 7-point scale from 0 - 6, where values of 0 indicates symptom is absent and a value of 6 means the symptom is a severe form. | Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26 |
| Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms. Total score will be equal to the sum of the 10 items (range between 0 and 60). | Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26 |
| Proportion of Subjects Who Achieved a Response, Defined as a 20% or Greater Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score From Double-blind Baseline of Study SEP361-201 | PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. | Week 26 |
| Pico Rivera |
| California |
| 90660 |
| United States |
| UCSD Medical Center UCSD Department of Psychiatry | San Diego | California | 92103-8229 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Kashinath Yadalam | Lake Charles | Louisiana | 70629 | United States |
| Pillar Clinical Research, LLC | Dallas | Texas | 75243 | United States |
| Bugát Pál Kórház-Rendelőintézet, Rehabilitációs Elmegyógyászati Osztály | Gyöngyös | Dózsa György | út 20-22 | Hungary |
| Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Pszichiatriai Osztaly | Gyula | 5700 | Hungary |
| Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" | Bucharest | 010825 | Romania |
| Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri "Sf. Stelian", Sectia Psihiatrie | Bucharest | 060222 | Romania |
| spitalul Clinic de Neuropsihiatrie Craiova ,Clinica II Psihiatrie | Craiova | 200473 | Romania |
| Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti | Iași | 700282 | Romania |
| St-Petersburg SHI Psychiatrical hospital #1 n.a. Kaschenko | Gatchina | 188357 | Russia |
| City Psychiatric Hospital of St. Nikolay Chudotvorets | Saint Petersburg | 190121 | Russia |
| FB=SBI"Saint Petersburg Scientific and Research Psychoneurological Institute n.a. V.M. Bekhterev" | Saint Petersburg | 192019 | Russia |
| SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov" | Saint Petersburg | 197341 | Russia |
| SPb SBIH "City Psychoneurological Dispensary #7 (with inpatient facilities)" | Saint Petersburg | 198020 | Russia |
| SHI Regional Clinical Psychiatry Hospital of St. Sofia | Saratov | 410060 | Russia |
| FSBEI HE "Smolensk State Medical University" of the MoH of the RF | Smolensk | 214019 | Russia |
| Sverdlov Regional Psychiatric Clinical Hospital | Yekaterinburg | 620030 | Russia |
| Regional Psychoneurological Hospital #3, Dept of Crisis Cond & Primary Psych Episode #1 | Ivano-Frankivsk | 76014 | Ukraine |
| CHI Kharkiv RCPH#3 Center of Emerg PsychSI Inst of Neur, Psych & Narc of NAMSU, Unit of Emergency Psychiatry and Narcology | Kharkiv | 61068 | Ukraine |
| CHI Kharkiv Regional Clinical Psychiatric Hospital #3, Psychiatric Department of Primary Psychotic Episod | Kharkiv | 61068 | Ukraine |
| CI Kherson Regional Psychiatric Hospital of Kherson RC | Kherson | 73488 | Ukraine |
| TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions | Kyiv | 04080 | Ukraine |
| CI Odesa Regional Medical Center of Mental Health | Odesa | 65006 | Ukraine |
| CI Cherkasy Regional Psychiatric Hospital of ChRC, Femail Dept #11, Male Dept #12 | Smila | 20708 | Ukraine |
| Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #6 Ternopil I.ya. Gorbachevskyi SMU | Ternopil | 46020 | Ukraine |
| Transcarpathian Regional Narcological Dispensary | Uzhhorod | 88000 | Ukraine |
| CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU | Vinnytsia | 21005 | Ukraine |
| Subjects Who Received Study Medication |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SEP-363856 | SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||
| Country | Count of Participants | Participants |
| ||||||||||||||||||||
| Double-blind Baseline BMI (Body Mass Index) Group | Count of Participants | Participants |
| ||||||||||||||||||||
| Open-label Baseline BMI (Body Mass Index) Group | Count of Participants | Participants |
| ||||||||||||||||||||
| Open-label Baseline Waist Circumference (cm) | Mean | Standard Deviation | cm |
| |||||||||||||||||||
| Open-label Baseline BMI (Body Mass Index) (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||||
| Open-label Baseline Weight (kg) | Mean | Standard Deviation | kg |
| |||||||||||||||||||
| Open-label Baseline Height (cm) | Mean | Standard Deviation | cm |
| |||||||||||||||||||
| Double-blind Baseline Waist Circumference (cm) | Mean | Standard Deviation | cm |
| |||||||||||||||||||
| Double-blind Baseline BMI (Body Mass Index) (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||||
| Double-blind Baseline Weight (kg) | Mean | Standard Deviation | kg |
| |||||||||||||||||||
| Double-blind Baseline Height (cm) | Mean | Standard Deviation | cm |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation | Number of Participants with overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation | Posted | Count of Participants | Participants | From first dose of study drug to last study visit (27 weeks) |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS) | Number of participants with suicidal ideation (SI) and suicidal behavior (SB) using the Columbia - Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior. | Posted | Count of Participants | Participants | Overall post Open-label Baseline treatment period (26 weeks) |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior. | Posted | Count of Participants | Participants | Overall post Open-label Baseline treatment period (26 weeks) |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856 | Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others. | Relapse population, which includes subjects who received at least one dose of open-label treatment and demonstrated a clinical response to 4 weeks of treatment with SEP-363856. Clinical response is defined as meeting (1) a decrease in PANSS total score of ≥ 20% from double-blind Baseline, AND (2) a CGI-S score ≤ 4. For PBO-SEP subjects, clinical response was evaluated at Week 4 of study SEP361-201. For SEP-SEP subjects, clinical response was evaluated at Week 4 of study SEP361-202. | Posted | Median | 95% Confidence Interval | Days | From the time of clinical response to relapse or censor (one day after the last study drug dose) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856 | Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others. | Relapse population, which includes subjects who received at least one dose of open-label treatment and demonstrated a clinical response to 4 weeks of treatment with SEP-363856. Clinical response is defined as meeting (1) a decrease in PANSS total score of ≥ 20% from double-blind Baseline, AND (2) a CGI-S score ≤ 4. For PBO-SEP subjects, clinical response was evaluated at Week 4 of study SEP361-201. For SEP-SEP subjects, clinical response was evaluated at Week 4 of study SEP361-202. | Posted | Count of Participants | Participants | From the time of clinical response to relapse or censor (one day after the last study drug dose) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology) | PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. | Subjects with PANSS data missing at a particular time point did not contribute to the summary for that time point. | Posted | Mean | Standard Deviation | Units on a scale | Double-blind Baseline (DB BLN), Open-label Baseline (OL BLN), Week 26 (Wk 26) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) Score | The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity. | Subjects with CGI-S score data missing at a particular time point did not contribute to the summary for that time point. | Posted | Mean | Standard Deviation | Units on a scale | Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total Score | The BNSS is a rating scale to measure the current level of severity of negative symptoms in schizophrenia and schizoaffective disorder. The measure is comprised of 13 individual items organized in 6 subscales. The 13 individual items provide a composite total score (ranging from 0 to 78). Each of the items are scored on a Likert-type 7-point scale from 0 - 6, where values of 0 indicates symptom is absent and a value of 6 means the symptom is a severe form. | Subjects with BNSS total score data missing at a particular time point did not contribute to the summary for that time point. | Posted | Mean | Standard Deviation | Units on a scale | Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms. Total score will be equal to the sum of the 10 items (range between 0 and 60). | Subjects with MADRS total score data missing at a particular time point did not contribute to the summary for that time point. | Posted | Mean | Standard Deviation | Units on a scale | Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who Achieved a Response, Defined as a 20% or Greater Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score From Double-blind Baseline of Study SEP361-201 | PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. | Subjects who received at least one dose of open-label treatment and had PANSS total score data available at Double-blind Baseline and Week 26 are included in analysis. | Posted | Count of Participants | Participants | Week 26 |
|
|
From first dose of study drug to last study visit (27 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SEP-363856 | SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily | 0 | 156 | 15 | 156 | 39 | 156 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute psychosis | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
|
In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CNS Medical Director | Sunovion Pharmaceuticals Inc. | 1 866-503-6351 | clinicaltrialdisclosure@sunovion.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2019 | Nov 30, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705647 | SEP-363856 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Russia |
|
| Ukraine |
|
| United States |
|
| >=25.0 - <30.0 kg/m^2 |
|
| >=30.0 kg/m^2 |
|
| >=25.0 - <30.0 kg/m^2 |
|
| >=30.0 kg/m^2 |
|
| Title | Measurements |
|---|---|
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| Adverse Events leading to discontinuation of study drug |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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