Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate changes in brain energy metabolism due to treatment with escitalopram in people with major depressive disorder.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital; National Institute of Mental Health (NIMH)
• Treatments: Citalopram; Dexetimide

Criteria

Inclusion Criteria:

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 Criteria:

• 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