Status:
COMPLETED
Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study will evaluate changes in brain energy metabolism due to treatment with escitalopram in people with major depressive disorder.
Detailed Description
Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often exp...
Eligibility Criteria
Inclusion
- For depressed subjects:
- Meets DSM-IV diagnostic criteria for major depressive disorder
- Score of greater than 16 on the Hamilton Depression Rating scale (17 items) at study entry
- Agrees to use an effective form of contraception throughout the study
- For healthy volunteers:
- Not currently taking any medications
- No lifetime history of major neurological, medical, psychiatric disorder, or head injury
- Agrees to use an effective form of contraception throughout the study
Exclusion
- Current suicidal ideation that may make study participation unsafe
- Current serious or unstable medical illness (e.g., cardiovascular, kidney, liver, respiratory, endocrine, neurologic, or blood-related disease)
- History of seizure disorder
- History of or current DSM-IV diagnosis of any of the following psychiatric illnesses within 12 months of study entry: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, mood congruent or mood incongruent psychotic features, substance dependence disorders (including alcohol)
- History of or current diagnosis of dementia, or a score of less than 26 on the Mini Mental Status Examination at screening
- History of multiple adverse drug reactions or allergic reaction to the study drugs
- Currently taking psychotropic drugs or antidepressant medications
- Clinical or laboratory evidence of hypothyroidism
- Failure to respond during current major depressive episode to at least one adequate antidepressant trial, defined as 6 weeks or more of treatment with 40 mg of citalopram per day (or its antidepressant equivalent)
- History of electroconvulsive therapy (ECT) within the 6 months prior to study entry
- Pregnant
- Subjects with a CGI score a 6 ("severely depressed") or 7 ("among the most extremely depressed patients")
- A BMI of 39 or greater, for comfort in scanner
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00183677
Start Date
July 1 2003
End Date
June 1 2009
Last Update
January 4 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114