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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377233
• Other study ID #: 13946A
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2011
• Last updated: November 13, 2015
• Start date: July 2011

Study information

• Verified date: November 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Zicronapine 10 mg encapsulated tablet once daily
10 mg daily
• Zicronapine 20 mg encapsulated tablet once weekly
20 mg weekly (on day 1 of each 7 day cycle)
• Zicronapine 30 mg encapsulated tablet once weekly
30 mg weekly (on day 1 of each 7 day cycle)
• Zicronapine 45 mg encapsulated tablet once weekly
45 mg weekly (on day 1 of each 7 day cycle)

Locations

Country	Name	City	State
United States	US002	Garden Grove	California
United States	US003	National City	California
United States	US001	Rockville	Maryland
United States	US004	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events as a measure of safety and tolerability		5 weeks	Yes
Secondary	Positive and Negative Syndrome Scale (PANSS) total and subscales change from baseline		5 weeks	No
Secondary	Clinical Global Impression Severity Scale (CGI-S) change from baseline		5 weeks	No
Secondary	Clinical Global Impression Improvement Scale (CGI-I)		5 weeks	No