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Cognitive Therapy for Recurrent Depression

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Robin Jarrett, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00118404
First received: July 6, 2005
Last updated: May 13, 2014
Last verified: May 2014
History of Changes
Results First Received: December 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Behavioral: Continuation phase cognitive therapy
Drug: Continuation phase fluoxetine
Other: Continuation phase pill placebo
Behavioral: Acute phase cognitive therapy

  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
Adult outpatients diagnosed with recurrent major depressive disorder (MDD) using the Structured Clinical Interview for Diagnostic and Statistical Manual-IV were recruited from January 2000-July 2008. The first diagnostic evaluation was completed in March 2000.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible patients (n=523) entered 12-14 weeks of acute phase cognitive therapy. Responders (no MDD & Hamilton Rating Scale for Depression [HRSD] ≤12) were divided by lower & higher risk based on the final 7 HRSD scores. Only consenting, higher risk patients (N=241) were randomized into the 3 arms below. See Jarrett &Thase (2010) for design details.

Reporting Groups
  Description
Continuation Phase Fluoxetine

Participants received acute phase cognitive therapy and continuation phase pill placebo

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months.
Continuation Phase Cognitive Therapy

Participants received acute phase and continuation phase cognitive therapy

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months.
Continuation Phase Pill Placebo

Participants received acute phase cognitive therapy and continuation phase fluoxetine

Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.

Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months.

Participant Flow:   Overall Study
    Continuation Phase Fluoxetine     Continuation Phase Cognitive Therapy     Continuation Phase Pill Placebo  
STARTED     86     86     69  
COMPLETED     62     70     49  
NOT COMPLETED     24     16     20  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Depressive Relapse or MDD   [ Time Frame: Measured at month 8 ]
  Show Outcome Measure 1

2.  Primary:   Depressive Relapse/Recurrence or MDD   [ Time Frame: Measured at month 20 ]
  Show Outcome Measure 2

3.  Primary:   Depressive Relapse/Recurrence or MDD   [ Time Frame: Measured at month 32 ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  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

To our knowledge in 2014 this is of the largest, cognitive therapy responders who presented with recurrent MDD and were followed longitudinally

Proficient therapists;competency measured.

Generalizability is limited by design characteristics.


  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: Dr. Robin B. Jarrett, Professor of Psychiatry
Organization: The University of Texas Southwestern Medical Center
phone: 214-648-5345
e-mail: Robin.Jarrett@UTSouthwestern.edu


Publications of Results:

Other Publications:


Responsible Party: Robin Jarrett, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00118404     History of Changes
Other Study ID Numbers: R01 MH58397, R01MH058397, R01MH069619, R01MH058356, R01MH069618
Study First Received: July 6, 2005
Results First Received: December 12, 2013
Last Updated: May 13, 2014
Health Authority: United States: Federal Government