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: February 22, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Schizophrenia
Drug: Zicronapine open-label lead-in 10 mg daily
Drug: Zicronapine 10 mg daily
Drug: Zicronapine 20 mg once weekly
Drug: Zicronapine 30 mg once weekly
Drug: Zicronapine 45 mg once weekly
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: 11 weeks for open-label period; 13 weeks for double-blind period ] [ Designated as safety issue: Yes ]
    Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)


Secondary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline [ Time Frame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period) ] [ Designated as safety issue: No ]
    The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).

  • Clinical Global Impression Severity Scale (CGI-S) Change From Baseline [ Time Frame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period) ] [ Designated as safety issue: No ]
    The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses their clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).

  • Clinical Global Impression Improvement Scale (CGI-I) [ Time Frame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period) ] [ Designated as safety issue: No ]
    The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment is made independent of whether the rater believes the improvement is drug-related or not.


Enrollment: 46
Study Start Date: July 2011
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zicronapine open-label lead-in 10 mg daily Drug: Zicronapine open-label lead-in 10 mg daily
Encapsulated tablet ,10 mg, once daily, open-label
Other Name: Lu 31-130
Experimental: Zicronapine 10 mg daily Drug: Zicronapine 10 mg daily
Encapsulated tablet, 10 mg, once daily, double-blind
Other Name: Lu 31-130
Experimental: Zicronapine 20 mg once weekly Drug: Zicronapine 20 mg once weekly
Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Other Name: Lu 31-130
Experimental: Zicronapine 30 mg once weekly Drug: Zicronapine 30 mg once weekly
Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Other Name: Lu 31-130
Experimental: Zicronapine 45 mg once weekly Drug: Zicronapine 45 mg once weekly
Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Other Name: Lu 31-130

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  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

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01377233     History of Changes
Other Study ID Numbers: 13946A 
Study First Received: June 20, 2011
Results First Received: January 15, 2016
Last Updated: February 22, 2016
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 Spectrum and Other Psychotic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 25, 2016