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fMRI Study of Treatment Changes in Major Depression

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ClinicalTrials.gov Identifier: NCT01027559
Recruitment Status : Completed
First Posted : December 8, 2009
Results First Posted : June 13, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Other
Conditions: Major Depression
Treatment
Interventions: Drug: Sertraline
Behavioral: Cognitive Behavioral Therapy

  Participant Flow

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
Prior to being assigned to a group, 6 depressed participants dropped from the study before being assigned to treatment type.

Reporting Groups
  Description
Depressed Group: CBT

Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.

Cognitive Behavioral Therapy: Visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and HAMD administration will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84.

Healthy Control Group Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
Depressed Group: Sertraline

Depressed participants randomized to receive sertraline (SRT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.

Sertraline: Visits will involve dispensing medication, side effects assessment and HAMD administration occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response.


Participant Flow:   Overall Study
    Depressed Group: CBT   Healthy Control Group   Depressed Group: Sertraline
STARTED   26   34   31 
COMPLETED   20   26   22 
NOT COMPLETED   6   8   9 



  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.
A total of 97 participants enrolled in the study (63 depressed and 34 controls). Of the 63 depressed participants enrolled in the study, 57 (26 CBT and 31 SRT) were assigned to a treatment group and completed at least some study-related activities. Six depressed participants dropped from the study before being assigned to treatment type.

Reporting Groups
  Description
Depressed Group: CBT

Depressed participants randomized to receive Cognitive Behavioral Therapy (CBT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.

Cognitive Behavioral Therapy: Visits for the CBT sessions will occur on or about Day = 3,Day = 7,Day = 10,Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 63, Day 70, Day 77, and Day 84. Visits to check for progress and HAMD administration will occur at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84.

Depressed Group: SRT

Depressed participants randomized to receive sertraline (SRT) for treatment. fMRI scan session occurs immediately prior to starting treatment, and a second fMRI scan will occur following 12 weeks of therapy.

Sertraline: Visits will involve dispensing medication, side effects assessment and HAMD administration occurring at Day = 0 and on or about Day = 14, Day 28, Day 42, Day 56, Day 70 and Day 84. Depressed patients treated with SRT will titrate up to a maximum dose of 200 mg daily depending on tolerability and inadequate antidepressant response.

Healthy Control Group Healthy controls will an fMRI scan session and their second fMRI scan session will occur approximately 12 weeks after.
Total Total of all reporting groups

Baseline Measures
   Depressed Group: CBT   Depressed Group: SRT   Healthy Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   31   34   91 
Age 
[Units: Years]
Mean (Full Range)
 31.54 
 (18 to 48) 
 33.29 
 (19 to 49) 
 31.64 
 (18 to 48) 
 32.16 
 (18 to 49) 
Sex/Gender, Customized 
[Units: Participants]
       
Female   19   26   28   77 
Male   7   5   5   19 
Region of Enrollment 
[Units: Participants]
       
United States   26   31   34   91 


  Outcome Measures

1.  Primary:   Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.   [ Time Frame: baseline visit and 8-week follow-up ]

2.  Primary:   Hamilton Depression Rating Scale Score at Baseline and 12 Weeks   [ Time Frame: Baseline and 12 weeks ]


  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
No text entered.


  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: Dr. Yvette Sheline
Organization: University of Pennsylvania
phone: 215-573-0082
e-mail: sheline@pennmedicine.upenn.edu



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01027559     History of Changes
Other Study ID Numbers: 081348
R01MH064821 ( U.S. NIH Grant/Contract )
2R01MH064821-05A2 ( U.S. NIH Grant/Contract )
DDTR A3-NSI ( Other Grant/Funding Number: National Institute of Mental Health )
First Submitted: December 4, 2009
First Posted: December 8, 2009
Results First Submitted: June 15, 2016
Results First Posted: June 13, 2018
Last Update Posted: July 17, 2018