A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment.
- Conditions
- Schizophrenia
- Interventions
- Drug: BI 498306 50 mg QDDrug: BI 409306 10 mg QDDrug: BI 409306 100 mg QDDrug: BI 498306 25 mg QDDrug: Placebo
- Registration Number
- NCT02281773
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 518
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dose 3 BI 498306 50 mg QD - dose 1 BI 409306 10 mg QD - dose 4 BI 409306 100 mg QD - dose 2 BI 498306 25 mg QD - placebo Placebo -
- Primary Outcome Measures
Name Time Method Suicidality as Assessed by Columbia Suicidal Severity Rating Scale (C-SSRS) Up to 12 weeks C-SSRS: Number (%) of subjects with an event of Suicidal Ideation (Wish to be dead, Non-specific active suicidal thoughts, Active suicidal ideation with any methods (not plan) without intent to act, Active suicidal ideation with some intent to act without specific plan, Active suicidal ideation with specific plan and intent) or Suicidal Behavior (Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide) or Self-injurious behavior without suicidal intent is presented. C-SSRS used only to evaluate whether the patient developed suicidal ideation or behavior and no composite score will be used. Questions in the 1st section of suicidal ideation and suicidal behavior assessments in C-SSRS are "yes" and "no" type questions. If patient had suicidal ideation or behavior, 2nd section will be performed to evaluate the details with the scale from 0 to 5 or 0 to 2 and the larger number means the more severe condition.
Occurrence of Serious Adverse Events (SAEs) (Including the Abnormalities of Physical Examination, Vital Signs, Electrocardiogram (ECG) Test and Laboratory Tests) Up to 20 weeks Occurrence of serious adverse events (SAEs) (including the abnormalities of physical examination, vital signs, electrocardiogram (ECG) test and laboratory tests).
Dramatic Worsening of Disease State as Assessed by Positive and Negative Syndrome Scale (PANSS) Baseline, Week 6 and Week 12 Dramatic worsening of disease state as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.
Occurrence of Protocol-specified Adverse Events of Special Interest (AESI) Up to 20 weeks Occurrence of Protocol-specified adverse events of special interest (AESI).
Change From Baseline in the Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment Baseline and Week 12 MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning problem solving, and social cognition. The composite score was calculated by summing over the standardised score of each domain for analysis and it varies from -20 to 99 with higher score indicating better outcome. The trial was set up as "learn and confirm" model including 2 stages. Stage 1 analysis was conducted to identify the meaningful cognition endpoint(s) (CANTAB domain(s)) and the selected endpoint(s) were to be pre-specified as the primary endpoint(s) for Stage 2 analysis. Since none of the CANTAB outcome measures was selected in the Stage 1 analysis at planned time based on the pre-specified criteria, the MCCB composite score was chosen as the primary endpoint in the Stage 2 analysis, as pre-defined.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 12 Weeks of Treatment Baseline and Week 12 Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale score after 12 weeks of treatment. The CGI-S is a one-item evaluation completed by the clinician on the patient's severity of psychopathology. The CGI-S was rated ordinally from one to 7. Higher scores indicate more severe symptoms.
Change in Psychopathology Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS) Baseline, Week 6 and Week 12 Change in psychopathology symptoms as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.
Patient Global Impressions-Improvement (PGI-I) Scale Score Measured After 12 Weeks of Treatment Up to 12 weeks Patient Global Impressions-Improvement (PGI-I) scale score measured after 12 weeks of treatment. The PGI of improvement is a simple evaluation completed by the patient to assess the patient's overall evaluation of his/her status. The PGI of improvement was rated ordinally from one to 7. Higher scores indicate more severe symptoms.
Change From Baseline in PANSS Negative Symptom Factor Score After 12 Weeks of Treatment (for Subset of Patients Diagnosed With Negative Symptom) Baseline and Week 12 Change from baseline in PANSS negative symptom factor score after 12 weeks of treatment (for subset of patients diagnosed with negative symptom). This outcome measure was not analysed due to low number of patients in the PANSS negative symptom subgroup. The PANSS negative symptom scale has 7 items. Each was rated from one to 7 points. The total factor score was the summation of the 7 points for each item, leading the total score ranging from 7 to 49.
Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Global Ratings After 12 Weeks of Treatment Baseline and Week 12 Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) global ratings after 12 weeks of treatment. SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functions. Each item was rated on a 4-point scale. Higher ratings reflected a greater degree of impairment. The SCoRS global total scores is the sum of the 20 items and it varies from 20 to 80 with 20 being the best outcome and 80 being the worst. If any individual item was missing, it was imputed with the average of that patient's non missing responses. If \>5 items were missing, the total score was missing.
Trial Locations
- Locations (42)
Artemis Institute for Clinical Research, LLC
🇺🇸San Diego, California, United States
Uptown Research Institute
🇺🇸Chicago, Illinois, United States
Comprehensive Clinical Development, Inc.
🇺🇸Cerritos, California, United States
Collaborative Neuroscience Network
🇺🇸Torrance, California, United States
Pacific Institute of Medical Research
🇺🇸Los Angeles, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Florida Clinical Research Center
🇺🇸Maitland, Florida, United States
Innovative Clinical Research
🇺🇸Lauderhill, Florida, United States
Behavioral Clinical Research, Inc.
🇺🇸North Miami, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Atlanta Center
🇺🇸Atlanta, Georgia, United States
Mid-America Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Lake Charles Clinical Trials LLC
🇺🇸Lake Charles, Louisiana, United States
St. Louis Clinical Trials
🇺🇸Saint Louis, Missouri, United States
Finger Lakes Research
🇺🇸Rochester, New York, United States
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Depression, Mood Disorders and Schizophrenia Treatment Centr
🇨🇦Burlington, Ontario, Canada
LVR-Klinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Uniklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Köln (AöR)
🇩🇪Köln, Germany
Hokkaido University Hospital
🇯🇵Hokkaido, Sapporo, Japan
Nara Medical University Hospital
🇯🇵Nara, Kashihara, Japan
Kansai Med. Univ. Med. Ctr., Osaka, Neuropsychiatry
🇯🇵Osaka, Moriguchi-city, Japan
Iwaki Clinic, Tokushima, Psychosomatic Medicine
🇯🇵Tokushima, Anan, Japan
Showa University East Hospital
🇯🇵Tokyo, Shinagawa, Japan
Chang-Hua Christian Hospital
🇨🇳Changhua, Taiwan
Taipei City Hospital
🇨🇳Taipei, Taiwan
Hizen Psychiatric Center, Saga, PSY
🇯🇵Saga, Kanzaki-gun, Japan
Comprehensive Clinical Development
🇺🇸Washington, D.C., District of Columbia, United States
Fujita Health University Hospital
🇯🇵Aichi, Toyoake, Japan
Kai-Syuan Psychiatric Hospital
🇨🇳Kaohsiung, Taiwan
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
K and S Professional Research Services, LLC
🇺🇸Little Rock, Arkansas, United States
Dr. Alexander McIntyre Inc.
🇨🇦Penticton, British Columbia, Canada
Kobe University Hospital
🇯🇵Hyogo, Kobe, Japan
National Center Neurology and Psychiatry
🇯🇵Tokyo, Kodaira, Japan
Showa University Karasuyama Hospital
🇯🇵Tokyo, Setagaya, Japan
NCKUH
🇨🇳Tainan, Taiwan
SRSD, Inc. dba Synergy San Diego
🇺🇸National City, California, United States