Phase 4
N=97
Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00183677 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Responder and Remission Status (%), Based on the Depression Rating Scale Score — 36; 32 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Escitalopram (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder and Remission Status (%), Based on the Depression Rating Scale Score |
36; 32 | — |
Summary
This study will evaluate changes in brain energy metabolism due to treatment with escitalopram in people with major depressive disorder.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00183677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.