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Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram

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ClinicalTrials.gov Identifier: NCT00183677
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Sponsor:
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 Depression
Intervention Drug: Escitalopram
Enrollment 97
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Label Escitalopram
Hide Arm/Group Description Participants will receive treatment with escitalopram.
Period Title: Overall Study
Started 97
Completed 53
Not Completed 44
Arm/Group Title Open Label Escitalopram
Hide Arm/Group Description Participants will receive treatment with escitalopram.
Overall Number of Baseline Participants 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants
<=18 years
0
   0.0%
Between 18 and 65 years
97
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants
41.54  (13.42)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants
Female
42
  43.3%
Male
55
  56.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 97 participants
97
1.Primary Outcome
Title Responder and Remission Status (%), Based on the Depression Rating Scale Score
Hide Description 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).
Time Frame Measured at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
97 patients with MDD (42 Female) enrolled in the 12 week study, 53 patients (27 Female) completed. Only completers were included in the primary outcome measure.
Arm/Group Title Open Label Escitalopram
Hide Arm/Group Description:
Participants received open treatment with escitalopram.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: participants
Clinical Responders 36
Clinical Remitters 32
Time Frame Adverse event data were collected over 12 weeks of participation in the study.
Adverse Event Reporting Description All gastrointestinal symptoms (e.g., nausea, diarrhea) were collected under the category gastrointestinal upset ("GI upset")
 
Arm/Group Title Open Label Escitalopram
Hide Arm/Group Description Participants will receive treatment with escitalopram.
All-Cause Mortality
Open Label Escitalopram
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open Label Escitalopram
Affected / at Risk (%) # Events
Total   0/97 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open Label Escitalopram
Affected / at Risk (%) # Events
Total   45/97 (46.39%)    
Gastrointestinal disorders   
GI Upset † [1]  17/97 (17.53%)  17
General disorders   
Headache †  11/97 (11.34%)  11
Insomnia/Sleep Disturbance †  11/97 (11.34%)  11
Decreased Appetite †  5/97 (5.15%)  5
Psychiatric disorders   
Fatigue † [2]  23/97 (23.71%)  23
Agitation † [3]  6/97 (6.19%)  6
Reproductive system and breast disorders   
Sexual Side Effects † [4]  10/97 (10.31%)  10
†
Indicates events were collected by systematic assessment
[1]
GI upset includes report of GI upset, nausea, diarrhea, gas, stomach cramps, and/or indigestion
[2]
Fatigue includes report of fatigue, sedation, drowsiness, hypersomnia, and/or lethargy.
[3]
Agitation includes report of agitation, jitteriness, and internal restlessness.
[4]
Sexual side effects include report of decreased sexual drive, anorgasmia, or erectile dysfunction.
[Not Specified]
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: Dan Iosifescu, MD, MSc
Organization: Massachusetts General Hospital
EMail: diosifescu@partners.org
Layout table for additonal information
Responsible Party: David Mischoulon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00183677     History of Changes
Other Study ID Numbers: K23MH067111 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: September 22, 2011
Results First Posted: January 4, 2017
Last Update Posted: January 4, 2017