Brain GABA Levels and Treatment Response in Major Depressive Disorder

NCT00464711 | Completed Phase 4 Results

• 1 other identifier: 2006-P-001295
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder.

Conditions

Major Depressive Disorder

Keywords

depression; biology

Outcome Measures

Primary Outcomes (1)

• Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores

  The primary outcome in this study was based on the Hamilton Rating Scale for Depression, 17 items (HAMD-17). Clinical Response status was defined as \> 50 % reduction in HAMD-17 scores from baseline to endpoint. Clinical Remitter status was defined as endpoint HAMD-17 score \< 8. 40 patients (21 female) with major depressive disorder (MDD) started the 12 week study treatment with escitalopram, 25 patients (15 female) completed the 12 weeks.

  12 weeks

Study Arms (1)

Escitalopram

OTHER

single arm

Drug: Escitalopram

Interventions

Escitalopram DRUG

Dose determined per clinical discretion. All participants begin on 10mg po qd of escitalopram, and can increase the dose to 30mg po qd over the 12 weeks of the study.

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:

• Meet diagnostic criteria for current Major Depressive Disorder
• Men or women aged 18-65
• Medication-free for one week prior to the start of the study
• Agrees to use an effective form of contraception throughout the study

You may not qualify if:

• Anyone who is suicidal
• Pregnant or breastfeeding women
• Anyone with a serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
• Anyone with a history of seizure disorder or hypothyroidism
• Anyone with a history of psychiatric disorders including bipolar disorder, schizophrenia, psychoses, or substance abuse (including alcohol abuse active within the last 12 months)
• Anyone with a history of intolerance or multiple adverse drug reactions or allergy to (es)citalopram.
• Patients who are currently taking medications active on GABA, including benzodiazepines.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Mclean Hospital: collaborator

Study Sites (1)

Depression Clinical and Research Program, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• Massachusetts General Hospital Depression Clinical and Research Program Website

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Dan Iosifescu
• Organization: Massachusetts General Hospital

diosifescu@partners.org

Study Officials

• Dan Iosifescu, MD

  Depression Clinical and Research Program, 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: David Mischoulon, M.D.

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: September 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 4, 2017
• Results First Posted: January 4, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)