Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram

NCT00183677 | Completed Phase 4 Results DMC

• 1 other identifier: K23MH067111
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Keywords

Brain Bioenergetic Metabolism; Magnetic Resonance Spectroscopy; Major Depressive Disorder; Treatment Response

Outcome Measures

Primary Outcomes (1)

• Responder and Remission Status (%), Based on the Depression Rating Scale Score

  The Hamilton Depression Rating Scale, 17 items (HAMD-17, range 0-52) was used to measure changes in depression severity from baseline to endpoint. Clinical Responder status was defined as \> 50% improvement (i.e., reduction) in HAMD-17 score from baseline to endpoint. Clinical Remission status was defined as HAMD-17 score \< 8 at endpoint (week 12 visit).

  Measured at Week 12

Study Arms (1)

Escitalopram

EXPERIMENTAL

Participants will receive open treatment with escitalopram.

Drug: Escitalopram

Interventions

Escitalopram DRUG

Escitalopram 10 to 30 mg per day for 12 weeks

Also known as: Lexapro

Escitalopram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dan Iosifescu, MD, MSc
• Organization: Massachusetts General Hospital

diosifescu@partners.org

Study Officials

• Dan V. Iosifescu, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: July 1, 2003
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 4, 2017
• Results First Posted: January 4, 2017

Record last verified: 2016-11

Locations

US (1)