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.
Source: ClinicalTrials.gov NCT02281773 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
1.2; 2.7; 2.8; 1.8; 2.5 | 0.1256 |
| PRIMARY Occurrence of Serious Adverse Events (SAEs) (Including the Abnormalities of Physical Examination, Vital Signs, Electrocardiogram (ECG) Test and Laboratory Tests) |
0.0; 0.0; 0.0; 0.0; 5.8 | — |
| PRIMARY Occurrence of Protocol-specified Adverse Events of Special Interest (AESI) |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Dramatic Worsening of Disease State as Assessed by Positive and Negative Syndrome Scale (PANSS) |
-0.68; -0.28; -1.09; -1.20; -1.81; -2.59 | — |
| PRIMARY Suicidality as Assessed by Columbia Suicidal Severity Rating Scale (C-SSRS) |
0.0; 1.2; 2.5; 1.2; 3.6 | — |
| SECONDARY Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Global Ratings After 12 Weeks of Treatment |
-2.2; -3.1; -2.0; -2.3; -2.5 | 0.5972 |
| SECONDARY Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 12 Weeks of Treatment |
-0.1; -0.1; -0.1; -0.1; -0.1 | 0.9399 |
| SECONDARY Patient Global Impressions-Improvement (PGI-I) Scale Score Measured After 12 Weeks of Treatment |
2.988; 2.883; 3.192; 3.049; 3.038 | — |
| SECONDARY Change From Baseline in PANSS Negative Symptom Factor Score After 12 Weeks of Treatment (for Subset of Patients Diagnosed With Negative Symptom) |
— | — |
| SECONDARY Change in Psychopathology Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS) |
-0.39; -0.22; -0.31; -0.79; -0.99; -1.36 | — |
Eligibility Criteria
Inclusion criteria
- Patients with established diagnoses of schizophrenia (per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)) with the following clinical features:
a) Clinically stable and are in the residual (non-acute) phase of their illness for at least 8 weeks b) Current antipsychotic and concomitant psychotropic medications must meet the criteria below: b)-1 Maintained on current atypical (second generation) antipsychotic medications (in any approved dosage form) other than Clozapine and on current dose for at least 8 weeks prior to randomisation, and/or b)-2 Maintained on current typical (first generation) antipsychotic medications and on current dose for at least 6 months, optionally combined with anticholinergics if treated with a stable dose for at least 6 months prior to randomisation, and/or b)-3 Maintained on current concomitant psychotropic medications other than anticholinergics, antiepileptics and lithium, and on current dose for at least 8 weeks prior to randomisation. Antiepileptics and lithium are allowed if initiated at least 6 months prior to randomisation.
b)-4 Anticholinergics, antiepileptics and lithium have been washed out for at least 6 months prior to randomisation if the treatments that patients were using before entering the clinical trial are discontinued.
c) Have no more than a "moderate" severity rating on hallucinations and delusions (Positive and Negative Syndrome Scale (PANSS)-positive syndrome Hallucinatory Behavior item score < =4 and Delusions item score < = 4) d) Have no more than a "moderate" severity rating on positive formal thought disorder (PANSS-positive syndrome Conceptual Disorganization item score < = 4) e) Have a minimal level of extrapyramidal symptoms (Simpson-Angus Scale total score < 6) and depressive symptoms (PANSS-general psychopathology syndrome Depression item score < = 4)
- Male or female patients age 18 to 55 years
- Patients must exhibit reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures,in the investigator's opinion.
- Signed and dated written informed consent by date of Visit 1 in accordance with GCP and the local legislation. If the patient needs a legal representative, then this legal representative must give written informed consent as well.
- Patients must have an identified informant who will be consistent throughout the study. The informant must interact with the subject at least 2 times a week.
Note: Informant ratings are needed for SCoRS global ratings at Randomisation Visit (Visit 2) and (early) End of Treatment Visit. In person informant ratings on the study visits are preferred whenever possible. However, if the informant is not available for in person ratings, telephone interview is acceptable. The informant must be available for a telephone interview at Visit 2 and (e)EOT Visit.
Exclusion criteria
- Patient treated with more than two antipsychotic medications (including more than two dosage forms)
- Patient's cognitive impairment severity compromises the validity of the cognitive outcome measures, in the clinical judgment of the investigator
- Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior)
- Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
- In the judgment of the investigator, any clinically significant finding of the medical examination (including BP, PR and ECG) or laboratory value deviating from normal or any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize a patient's safety while participating in the clinical trial
- History or diagnosis of symptomatic and unstable/uncontrolled gastrointestinal, hepatic, renal,
Data sourced from ClinicalTrials.gov (NCT02281773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.