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

June 20, 2011
February 22, 2016
July 2011
February 2012   (final data collection date for primary outcome measure)
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)
Safety and tolerability: Adverse event monitoring [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01377233 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Zicronapine open-label lead-in 10 mg daily
    Encapsulated tablet ,10 mg, once daily, open-label
    Other Name: Lu 31-130
  • Drug: Zicronapine 10 mg daily
    Encapsulated tablet, 10 mg, once daily, double-blind
    Other Name: Lu 31-130
  • 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
  • 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
  • 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
  • Experimental: Zicronapine open-label lead-in 10 mg daily
    Intervention: Drug: Zicronapine open-label lead-in 10 mg daily
  • Experimental: Zicronapine 10 mg daily
    Intervention: Drug: Zicronapine 10 mg daily
  • Experimental: Zicronapine 20 mg once weekly
    Intervention: Drug: Zicronapine 20 mg once weekly
  • Experimental: Zicronapine 30 mg once weekly
    Intervention: Drug: Zicronapine 30 mg once weekly
  • Experimental: Zicronapine 45 mg once weekly
    Intervention: Drug: Zicronapine 45 mg once weekly
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
Not Provided
February 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01377233
13946A
Yes
Not Provided
Not Provided
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP