Trial record 1 of 1 for:
NCT01058668
Safety and Efficacy of Cariprazine for Bipolar I Disorder
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01058668 |
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Recruitment Status :
Completed
First Posted : January 29, 2010
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
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Sponsor:
Forest Laboratories
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
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Brief Summary:
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mania Bipolar I Disorder | Drug: Cariprazine Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 497 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder |
| Study Start Date : | February 2010 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | December 2011 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cariprazine (3-6 mg/day)
Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
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Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. |
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Experimental: Cariprazine (6-12 mg/day)
Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
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Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. |
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Placebo Comparator: Placebo
Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
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Drug: Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks. |
Primary Outcome Measures :
- Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 [ Time Frame: Baseline, Week 3 ]The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
Secondary Outcome Measures :
- Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 [ Time Frame: Baseline, Week 3 ]The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who have provided informed consent prior to any study specific procedures
- Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
- Voluntarily hospitalized for current manic episode
- Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
Exclusion Criteria:
- Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058668
Locations
Show 66 study locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
| Study Director: | Elizabeth Diaz, MD | Forest Laboratories |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01058668 |
| Other Study ID Numbers: |
RGH-MD-33 |
| First Posted: | January 29, 2010 Key Record Dates |
| Results First Posted: | April 12, 2017 |
| Last Update Posted: | April 12, 2017 |
| Last Verified: | March 2017 |
Keywords provided by Forest Laboratories:
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Acute Mania Bipolar I Disorder |
Additional relevant MeSH terms:
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Mania Disease Pathologic Processes Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |
Cariprazine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |