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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zicronapine open-label lead-in 10 mg daily

Group Type EXPERIMENTAL

Zicronapine open-label lead-in 10 mg daily

Intervention Type DRUG

Encapsulated tablet ,10 mg, once daily, open-label

Zicronapine 10 mg daily

Group Type EXPERIMENTAL

Zicronapine 10 mg daily

Intervention Type DRUG

Encapsulated tablet, 10 mg, once daily, double-blind

Zicronapine 20 mg once weekly

Group Type EXPERIMENTAL

Zicronapine 20 mg once weekly

Intervention Type DRUG

Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Zicronapine 30 mg once weekly

Group Type EXPERIMENTAL

Zicronapine 30 mg once weekly

Intervention Type DRUG

Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Zicronapine 45 mg once weekly

Group Type EXPERIMENTAL

Zicronapine 45 mg once weekly

Intervention Type DRUG

Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Interventions

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Zicronapine open-label lead-in 10 mg daily

Encapsulated tablet ,10 mg, once daily, open-label

Intervention Type DRUG

Zicronapine 10 mg daily

Encapsulated tablet, 10 mg, once daily, double-blind

Intervention Type DRUG

Zicronapine 20 mg once weekly

Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Intervention Type DRUG

Zicronapine 30 mg once weekly

Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Intervention Type DRUG

Zicronapine 45 mg once weekly

Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Intervention Type DRUG

Other Intervention Names

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Lu 31-130 Lu 31-130 Lu 31-130 Lu 31-130 Lu 31-130

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No