- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01377233
Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
February 22, 2016 updated by: H. Lundbeck A/S
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Garden Grove, California, United States, 92845
- US002
-
National City, California, United States, 91950
- US003
-
San Diego, California, United States, 92102
- US004
-
-
Maryland
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Rockville, Maryland, United States, 20850
- US001
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Zicronapine open-label lead-in 10 mg daily
|
Encapsulated tablet ,10 mg, once daily, open-label
Other Names:
|
EXPERIMENTAL: Zicronapine 10 mg daily
|
Encapsulated tablet, 10 mg, once daily, double-blind
Other Names:
|
EXPERIMENTAL: Zicronapine 20 mg once weekly
|
Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Other Names:
|
EXPERIMENTAL: Zicronapine 30 mg once weekly
|
Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Other Names:
|
EXPERIMENTAL: Zicronapine 45 mg once weekly
|
Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
11 weeks for open-label period; 13 weeks for double-blind period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
|
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).
|
8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
|
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.
|
8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (ACTUAL)
February 1, 2012
Study Registration Dates
First Submitted
June 20, 2011
First Submitted That Met QC Criteria
June 20, 2011
First Posted (ESTIMATE)
June 21, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 22, 2016
Last Update Submitted That Met QC Criteria
February 22, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13946A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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