Phase 2
Completed N=46
Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT01377233 ↗Enrolled (actual)
46
Serious AEs
3.4%
Results posted
Mar 2016
Primary outcomePrimary: Number of Patients With Adverse Events as a Measure of Safety and Tolerability — 12; 8; 4; 4 participants
Summary
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events as a Measure of Safety and Tolerability |
12; 8; 4; 4; 9 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline |
-8.0; -8.7; -10.6; -12.2; -1.5; -0.8 | — |
| SECONDARY Clinical Global Impression Severity Scale (CGI-S) Change From Baseline |
-0.5; -0.5; -0.2; -0.7 | — |
| SECONDARY Clinical Global Impression Improvement Scale (CGI-I) |
2.9; 3.4; 3.0; 2.9 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR)
- A score of =60 on Positive and Negative Syndrome Scale (PANSS)
- A score of <=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness)
Exclusion Criteria
- Acute exacerbation requiring hospitalization within the last 3 months OR requiring change of antipsychotic medication within the last 4 weeks
- Diagnosis or history of substance dependence or substance abuse according to DSM-IV-TR within the last 3 months
- Significant risk of harming himself/herself or others
- Positive serology for hepatitis A, B, C, or HIV
- Present condition that might compromise liver function
- Medical or neurological disorder or treatment that could interfere with study treatment or compliance
- Previous exposure to zicronapine
Other inclusion and exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01377233). 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.