Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00183677
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : January 4, 2017
Last Update Posted : January 4, 2017
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Open Label Escitalopram Participants will receive treatment with escitalopram.

Participant Flow:   Overall Study
    Open Label Escitalopram

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Open Label Escitalopram Participants will receive treatment with escitalopram.

Baseline Measures
   Open Label Escitalopram 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      97 100.0% 
>=65 years      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 41.54  (13.42) 
[Units: Participants]
Count of Participants
Female      42  43.3% 
Male      55  56.7% 
Region of Enrollment 
[Units: Participants]
United States   97 

  Outcome Measures

1.  Primary:   Responder and Remission Status (%), Based on the Depression Rating Scale Score   [ Time Frame: Measured at Week 12 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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:  
Name/Title: Dan Iosifescu, MD, MSc
Organization: Massachusetts General Hospital

Responsible Party: David Mischoulon, MD, Massachusetts General Hospital 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