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Phase 4 N=97 Treatment

Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram

Depression

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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