Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram

Completed · Phase 4

Conditions studied: Depression

In brief

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

Key facts

Study ID

NCT00183677

Run by

Massachusetts General Hospital

People needed

97

Starts

2003-07-01

Expected to finish

2009-06-01

Last updated by the study team

2017-01-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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