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
NCT number | NCT01377233 |
Other study ID # | 13946A |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | June 20, 2011 |
Last updated | November 13, 2015 |
Start date | July 2011 |
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 |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
United States,
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 |
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