Bipolar Depression Clinical Trial
Official title:
The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder: A Randomized, Placebo-Controlled Trial of Acetyl-L-Carnitine and Alpha-Lipoic Acid for the Treatment of Bipolar Depression
Verified date | June 2012 |
Source | Mclean Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary objective of this 15-week clinical trial is to test the hypothesis that treatment with two proven mitochondrial enhancers, acetyl-L-carnitine (ALCAR) and α-lipoic acid (ALA), has significantly greater efficacy than placebo as an augmentation treatment in bipolar depressed patients who display an incomplete response to conventional treatments.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male or female age 18-65 years. - Meets DSM-IV criteria for Bipolar Disorder, type I with current episode depressed. - Current score of greater than or equal to 18 on the 21-Item Hamilton Depression Rating Scale at Visits 1 and 2. - Maintained on a stable treatment regimen with no changes in medication dosages for at least two weeks prior to study entry. Exclusion Criteria: - Unwilling or unable to provide informed consent - Score of greater than or equal to 12 on the Young Mania Rating Scale at Visit 1 or 2. - Current suicidal or homicidal ideation. - Active psychotic symptoms. - Lifetime history of schizophrenia or obsessive-compulsive disorder. - DSM-IV diagnosis of alcohol or substance dependence in the 3 months prior to screening. - Clinically significant medical condition that would interfere with study participation. - History of hypersensitivity to ACLCAR or ALA. - Pregnant or lactating. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | McLean Hospital | Belmont | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital | Stanley Medical Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The 25-Item Hamilton Depression Rating Scale. | Scores could range from 0 - 72 units on a scale, with 0 representing the least number of depressive symptoms and 72 representing the most number of depressive symptoms. | Baseline to 15 Weeks | No |
Primary | The Montgomery-Asberg Depression Rating Scale | Scores could range from 0 - 60 units on a scale with 0 representing the least number of depressive symptoms and 60 representing the most number of depressive symptoms. | Baseline to 15 weeks | No |
Primary | The Young Mania Rating Scale | The scores could range from 0 - 60 units on a scale with 0 representing the least number of manic symptoms and 60 representing the most number of manic symptoms. | Baseline to 15 weeks | No |
Primary | Clinical Global Impression-Severity | Scores could range from 0 - 7 units on a scale, with 0 representing the least severe ("Normal, not at all ill") and 7 representing the most severe ("Among the most extremely ill patients"). | Baseline to 15 weeks | No |
Secondary | Phosphorus MRS Scans on 4T Scanner | Whole brain total NTP levels as measured by a phosphorus MRS scan on the 4T scanner. The data could range from 0 - 1, with 0 representing the lowest NTP level and 1 representing the highest NTP level. | Baseline to 12 weeks | No |
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