Schizophrenia Clinical Trial
Official title:
A 26-Week Open-label Safety and Tolerability Extension Study of SEP-363856 in Adult Subjects With Schizophrenia
Verified date | February 2022 |
Source | Sunovion |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia
Status | Completed |
Enrollment | 157 |
Est. completion date | January 29, 2019 |
Est. primary completion date | January 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | 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. - Subject has completed Study SEP361 201 through Week 4 - Subject has not taken any medication other than the study drug for the purpose of controlling schizophrenia symptoms during Study SEP361 201. - Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361 201; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test. - Male subjects with female partner(s) of childbearing potential must agree to avoid fathering a child and use acceptable methods of birth control from screening until at least 30 days after the last study drug administration Exclusion Criteria: - Subject answers "yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Visit 7 of Study SEP361 201. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation. - Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study. - Subject has a positive urine drug screen (UDS) or breath alcohol test at Visit 7 of Study SEP361 201. - Subject is pregnant or lactating. - Subject is at high risk of non-compliance in the Investigator's opinion. - Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study. |
Country | Name | City | State |
---|---|---|---|
Hungary | Bugát Pál Kórház-Rendelointézet, Rehabilitációs Elmegyógyászati Osztály | Gyongyos | Dózsa György |
Hungary | Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Pszichiatriai Osztaly | Gyula | |
Romania | Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri "Sf. Stelian", Sectia Psihiatrie | Bucuresti | |
Romania | Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" | Bucuresti | |
Romania | spitalul Clinic de Neuropsihiatrie Craiova ,Clinica II Psihiatrie | Craiova | |
Romania | Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti | Iasi | |
Russian Federation | Sverdlov Regional Psychiatric Clinical Hospital | Ekaterinburg | |
Russian Federation | St-Petersburg SHI Psychiatrical hospital #1 n.a. Kaschenko | Gatchina | |
Russian Federation | SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov" | Saint-Petersburg | |
Russian Federation | SHI Regional Clinical Psychiatry Hospital of St. Sofia | Saratov | |
Russian Federation | FSBEI HE "Smolensk State Medical University" of the MoH of the RF | Smolensk | |
Russian Federation | City Psychiatric Hospital of St. Nikolay Chudotvorets | St. Petersburg | |
Russian Federation | FB=SBI"Saint Petersburg Scientific and Research Psychoneurological Institute n.a. V.M. Bekhterev" | St. Petersburg | |
Russian Federation | SPb SBIH "City Psychoneurological Dispensary #7 (with inpatient facilities)" | St. Petersburg | |
Ukraine | Regional Psychoneurological Hospital #3, Dept of Crisis Cond & Primary Psych Episode #1 | Ivano Frankivsk | |
Ukraine | CHI Kharkiv RCPH#3 Center of Emerg PsychSI Inst of Neur, Psych & Narc of NAMSU, Unit of Emergency Psychiatry and Narcology | Kharkiv | |
Ukraine | CHI Kharkiv Regional Clinical Psychiatric Hospital #3, Psychiatric Department of Primary Psychotic Episod | Kharkiv | |
Ukraine | CI Kherson Regional Psychiatric Hospital of Kherson RC | Kherson, Vil Stepanivka | |
Ukraine | TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions | Kyiv | |
Ukraine | CI Odesa Regional Medical Center of Mental Health | Odesa | |
Ukraine | CI Cherkasy Regional Psychiatric Hospital of ChRC, Femail Dept #11, Male Dept #12 | Smila | |
Ukraine | Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #6 Ternopil I.ya. Gorbachevskyi SMU | Ternopil | |
Ukraine | Transcarpathian Regional Narcological Dispensary | Uzhgorod | |
Ukraine | CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU | Vinnytsia | |
United States | Atlanta Center for Medical Research | Atlanta | Georgia |
United States | Pillar Clinical Research, LLC | Dallas | Texas |
United States | Kashinath Yadalam | Lake Charles | Louisiana |
United States | Woodland International research Group | Little Rock | Arkansas |
United States | CNRI-Los Angeles, LLC | Pico Rivera | California |
United States | UCSD Medical Center UCSD Department of Psychiatry | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Sunovion |
United States, Hungary, Romania, Russian Federation, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). |
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. | Week 26 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |