A Randomised, Double-blind, Parallel-group, Explorative Study of the Safety, Tolerability, and Pharmacokinetics of Daily Dosing Compared to Weekly Dosing of Zicronapine in Patients With Schizophrenia
Overview
- Phase
- Phase 2
- Intervention
- Zicronapine open-label lead-in 10 mg daily
- Conditions
- Schizophrenia
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 46
- Locations
- 4
- Primary Endpoint
- Number of Patients With Adverse Events as a Measure of Safety and Tolerability
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Detailed Description
The study includes 2 treatment periods. The open-label run-in period will begin at patient enrolment and continue for 3 weeks, during which all patients will receive once daily treatment with zicronapine. The double-blind period will begin at patient randomization and continue for 5 weeks, during which the patients will be assigned to one group receiving once daily treatment with zicronapine and 3 groups receiving once weekly treatment with zicronapine.
Investigators
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 \<=4 (moderately ill) on Clinical Global Impression - Severity of Illness (CGI-S) scale
- •A total score \>=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.
Arms & Interventions
Zicronapine open-label lead-in 10 mg daily
Intervention: Zicronapine open-label lead-in 10 mg daily
Zicronapine 10 mg daily
Intervention: Zicronapine 10 mg daily
Zicronapine 20 mg once weekly
Intervention: Zicronapine 20 mg once weekly
Zicronapine 30 mg once weekly
Intervention: Zicronapine 30 mg once weekly
Zicronapine 45 mg once weekly
Intervention: Zicronapine 45 mg once weekly
Outcomes
Primary Outcomes
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Time Frame: 11 weeks for open-label period; 13 weeks for double-blind period
Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)
Secondary Outcomes
- Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline(8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period))
- Clinical Global Impression Improvement Scale (CGI-I)(8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period))
- Clinical Global Impression Severity Scale (CGI-S) Change From Baseline(8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period))