Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression
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| ClinicalTrials.gov Identifier: NCT00852202 |
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Recruitment Status :
Completed
First Posted : February 26, 2009
Results First Posted : August 23, 2018
Last Update Posted : August 23, 2018
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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 purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bipolar Depression | Drug: cariprazine Drug: placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 234 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression |
| Actual Study Start Date : | June 30, 2009 |
| Actual Primary Completion Date : | June 15, 2010 |
| Actual Study Completion Date : | June 15, 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
0.25 - 0.75 mg/day cariprazine capsules, oral administration, once daily dosing.
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Drug: cariprazine
Drug: cariprazine (0.25 - 0.75 mg/day) |
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Experimental: 2
1.5 - 3.0 mg/day cariprazine capsules, oral administration, once daily dosing.
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Drug: cariprazine
Drug: cariprazine (1.5 - 3.0 mg/day) |
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Placebo Comparator: 3
Matching placebo capsules, oral administration, once daily dosing.
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Drug: placebo
placebo capsules, oral administration, once daily dosing |
Primary Outcome Measures :
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline to Week 8 ]The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity.
Secondary Outcome Measures :
- Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I ) [ Time Frame: Baseline to Week 8 ]The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse.
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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:
- Men and women, 18-65 years old
- Currently meet the DSM-IV-TR criteria for Bipolar I or II Disorder without psychotic features, with a current depressive episode
- A verified previous manic, hypomanic, or mixed episode
- Score of 20 or higher on the HAMD-17
- Score of 2 or higher on Item 1 of the HAMD
Exclusion Criteria:
- Score greater than 12 on the Young Mania Rating Scale
- Eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months prior to Visit 1
- Principal DSM-IV-TR-based diagnosis of an axis I disorder other than bipolar disorder (a secondary diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or specific phobias is acceptable)
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): NCT00852202
Locations
Show 26 study locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
| Study Director: | William Greenberg, MD | Forest Research Institute, a subsidiary of Forest Laboratories, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT00852202 |
| Other Study ID Numbers: |
RGH-MD-52 |
| First Posted: | February 26, 2009 Key Record Dates |
| Results First Posted: | August 23, 2018 |
| Last Update Posted: | August 23, 2018 |
| Last Verified: | August 2018 |
Keywords provided by Forest Laboratories:
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bipolar depression |
Additional relevant MeSH terms:
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Depression Depressive Disorder Bipolar Disorder Behavioral Symptoms Mood Disorders Mental Disorders Bipolar and Related Disorders |
Cariprazine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |