Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S

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.