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

Lundbeck

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Zicronapine open-label lead-in 10 mg daily; Drug: Zicronapine 30 mg once weekly; Drug: Zicronapine 20 mg once weekly; Drug: Zicronapine 45 mg once weekly; Drug: Zicronapine 10 mg daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT01377233

13946A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 5 patient groups

Zicronapine open-label lead-in 10 mg daily

Experimental group

Treatment:

Drug: Zicronapine open-label lead-in 10 mg daily

Zicronapine 10 mg daily

Experimental group

Treatment:

Drug: Zicronapine 10 mg daily

Zicronapine 20 mg once weekly

Experimental group

Treatment:

Drug: Zicronapine 20 mg once weekly

Zicronapine 30 mg once weekly

Experimental group

Treatment:

Drug: Zicronapine 30 mg once weekly

Zicronapine 45 mg once weekly

Experimental group

Treatment:

Drug: Zicronapine 45 mg once weekly