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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01377233
First received: June 20, 2011
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of once-a-week dosing of zicronapine, compared to daily dosing of zicronapine.


Condition Intervention Phase
Schizophrenia
Drug: Zicronapine
Phase 2

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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentrations of zicronapine and its metabolite Lu AA22774 [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale (PANSS) total and subscales change from baseline [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression Severity Scale (CGI-S) change from baseline [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression Improvement Scale (CGI-I) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: July 2011
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zicronapine basis dose daily Drug: Zicronapine
basis dose daily
Other Name: Lu 31-130
Experimental: Zicronapine lowest dose once weekly Drug: Zicronapine
lowest comparison dose on day 1 of each 7 day cycle
Other Name: Lu 31-130
Experimental: Zicronapine medium dose once weekly Drug: Zicronapine
medium comparison dose on day 1 of each 7 day cycle
Other Name: Lu 31-130
Experimental: Zicronapine highest dose once weekly Drug: Zicronapine
highest comparison dose on day 1 of each 7 day cycle
Other Name: Lu 31-130

Detailed Description:

The study includes 2 treatment periods. The open-label, run-in, period will begin at patient enrolment into the study and continue for 3 weeks; during which all patients will receive treatment with zicronapine daily. 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 treatment with zicronapine daily and 3 groups receiving once-a-week treatment with zicronapine.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV)
  • A severity score of Clinical Global Impression Scale (CGI) >=4
  • A total score of Positive and Negative Syndrome Scale (PANSS) >=60
  • A score of <=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness)

Exclusion Criteria:

  • Acute exacerbation which required hospitalization within the last 3 months OR required change of antipsychotic medication within the last 4 weeks
  • A current diagnosis or a history of substance dependence or substance abuse according to the DSM-IV-TR in the past 3 months
  • A significant risk of harming himself/herself or others
  • A positive serology for Hepatitis A, B, C, or HIV
  • A present condition that might compromise liver function
  • A medical or neurological disorder or treatment that could interfere with study treatment or compliance

Other inclusion and exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377233

Locations
United States, California
US002
Garden Grove, California, United States, 92845
US003
National City, California, United States, 91950
US004
San Diego, California, United States, 92102
United States, Maryland
US001
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01377233     History of Changes
Other Study ID Numbers: 13946A
Study First Received: June 20, 2011
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by H. Lundbeck A/S:
Schizophrenia
Antipsychotic
Zicronapine
Lu 31-310

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014