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Brain Energy Metabolism in Individuals With Major Depressive Disorder Receiving Escitalopram

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Mischoulon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00183677
First received: September 13, 2005
Last updated: November 4, 2016
Last verified: November 2016
Results First Received: September 22, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Depression
Intervention: Drug: Escitalopram

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Description
Open Label Escitalopram Participants will receive treatment with escitalopram.

Participant Flow:   Overall Study
    Open Label Escitalopram
STARTED   97 
COMPLETED   53 
NOT COMPLETED   44 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Open Label Escitalopram Participants will receive treatment with escitalopram.

Baseline Measures
   Open Label Escitalopram 
Overall Participants Analyzed 
[Units: Participants]
 97 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      97 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.54  (13.42) 
Gender 
[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
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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
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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
e-mail: diosifescu@partners.org



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 )
Study First Received: September 13, 2005
Results First Received: September 22, 2011
Last Updated: November 4, 2016