Clinical trial NCT01377233: Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotic
Zicronapine
Lu 31-310
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2011-06-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 11 weeks for open-label period; 13 weeks for double-blind period
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline
timeFrame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
measure: Clinical Global Impression Severity Scale (CGI-S) Change From Baseline
timeFrame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
measure: Clinical Global Impression Improvement Scale (CGI-I)
timeFrame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: US002
state: California
city: National City
country: United States
facility: US003
state: California
city: San Diego
country: United States
facility: US004
state: California
city: Rockville
country: United States
facility: US001
state: Maryland
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: