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

Completed · Phase 2

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01377233

Run by

H. Lundbeck A/S

People needed

46

Starts

2011-07-01

Last updated by the study team

2016-03-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• US002 — Garden Grove, California, United States
• US003 — National City, California, United States
• US004 — San Diego, California, United States
• US001 — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

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