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Brain GABA Levels and Treatment Response in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00464711
Recruitment Status : Completed
First Posted : April 24, 2007
Results First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Sponsor:
Collaborator:
Mclean Hospital
Information provided by (Responsible Party):
David Mischoulon, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: Escitalopram
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Escitalopram
Hide Arm/Group Description 40 subjects met inclusion/exclusion criteria and started treatment with escitalopram
Period Title: Overall Study
Started 40
Completed 25
Not Completed 15
Arm/Group Title Escitalopram
Hide Arm/Group Description 40 subjects met inclusion/exclusion criteria and started study treatment
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
38.675  (14.08)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
21
  52.5%
Male
19
  47.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores
Hide Description

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.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
40 patients (21 female) with MDD enrolled in the 12 week study, 25 patients (15 Female) completed. Current analyses are based on completers only.
Arm/Group Title Open Label Escitalopram
Hide Arm/Group Description:
All subjects were treated with open label escitalopram
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
Clinical Response 16
Clinical Remission 14
Time Frame Adverse events were collected over 12 weeks of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram
Hide Arm/Group Description 40 subjects met inclusion/exclusion criteria and started study treatment
All-Cause Mortality
Escitalopram
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram
Affected / at Risk (%) # Events
Total   0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Escitalopram
Affected / at Risk (%) # Events
Total   20/40 (50.00%)    
Gastrointestinal disorders   
GI Upset  [1]  8/40 (20.00%)  8
General disorders   
Insomnia   9/40 (22.50%)  9
Fatigue/Sedation   5/40 (12.50%)  5
Headache   4/40 (10.00%)  4
Sexual Side Effects  [2]  4/40 (10.00%)  4
Jitteriness/Agitation   2/40 (5.00%)  2
Decreased Appetite   2/40 (5.00%)  2
Increased sweatiness   2/40 (5.00%)  2
Increased Appetite   2/40 (5.00%)  2
Indicates events were collected by systematic assessment
[1]
GI upset category includes GI upset, nausea, diarrhea, Gas, stomach cramps, indigestion
[2]
Sexual side effects included reports of general sexual side effects, decreased sex drive, anorgasmia, and erectile dysfunction.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dan Iosifescu
Organization: Massachusetts General Hospital
EMail: diosifescu@partners.org
Layout table for additonal information
Responsible Party: David Mischoulon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00464711     History of Changes
Other Study ID Numbers: 2006-P-001295
First Submitted: April 23, 2007
First Posted: April 24, 2007
Results First Submitted: September 15, 2014
Results First Posted: January 4, 2017
Last Update Posted: January 4, 2017