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Functional MRI Before and After Treatment for Depression

This study has been terminated.
(Funding ended)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896441
First Posted: May 11, 2009
Last Update Posted: October 13, 2017
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.
Information provided by (Responsible Party):
Jennifer Keller, Stanford University
Results First Submitted: October 11, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Depression
Mood Disorders
Depressive Disorder
Intervention: Drug: Citalopram

  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
5 participants in the Healthy controls group withdrew consent prior to allocation to study arm.

Reporting Groups
  Description
Depressed Depressed individuals
Healthy Controls Participants with no history of psychiatric illness

Participant Flow:   Overall Study
    Depressed   Healthy Controls
STARTED   17   9 
COMPLETED   15   9 
NOT COMPLETED   2   0 



  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.
2 participants in the Depressed arm who did not complete study per protocol are not included in the analysis.

Reporting Groups
  Description
Depressed Depressed individuals
Healthy Controls Participants with no history of psychiatric illness
Total Total of all reporting groups

Baseline Measures
   Depressed   Healthy Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   9   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.00  (12.6)   31.92  (11.2)   36.50  (12.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  73.3%      3  33.3%      14  58.3% 
Male      4  26.7%      6  66.7%      10  41.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale Percent Change From Day 0 to D56   [ Time Frame: % change from baseline to Day 56 ( week 8) ]

2.  Primary:   Voxel-wise Changes in Resting State Functional Connectivity to the Posterior Cingulate Cortex   [ Time Frame: baseline and week 8 ]

3.  Secondary:   Hamilton Anxiety Scale   [ Time Frame: % change in anxiety from Day 1 to Day 56 (week 8) ]


  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: Mike Greicius
Organization: Stanford University
phone: 650-723-8331
e-mail: greicius@stanford.edu



Responsible Party: Jennifer Keller, Stanford University
ClinicalTrials.gov Identifier: NCT00896441     History of Changes
Other Study ID Numbers: SU-04202009-2339
Stanford IRB #15305 ( Other Identifier: Stanford University Institutional Review Board )
First Submitted: May 7, 2009
First Posted: May 11, 2009
Results First Submitted: October 11, 2016
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017