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OpenTrials
Completed

NCT Number: NCT01377233

Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

US002, Garden Grove, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zicronapine open-label lead-in 10 mg daily

Drug

Encapsulated tablet ,10 mg, once daily, open-label

Other names: Lu 31-130

Zicronapine 10 mg daily

Drug

Encapsulated tablet, 10 mg, once daily, double-blind

Other names: Lu 31-130

Zicronapine 20 mg once weekly

Drug

Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Other names: Lu 31-130

Zicronapine 30 mg once weekly

Drug

Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Other names: Lu 31-130

Zicronapine 45 mg once weekly

Drug

Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Other names: Lu 31-130

Primary outcomes

  1. 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

    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 outcomes

  1. 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)

    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).

  2. 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)

    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).

  3. Clinical Global Impression Improvement Scale (CGI-I)

    Time frame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)

    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.

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
First posted
Jun 21, 2011
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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