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Cognitive Therapy for Recurrent Depression

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ClinicalTrials.gov Identifier: NCT00118404
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Robin Jarrett, University of Texas Southwestern Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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

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


  Outcome Measures

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


  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

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

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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Robin Jarrett, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00118404     History of Changes
Obsolete Identifiers: NCT00183664, NCT00218764
Other Study ID Numbers: R01MH058397 ( U.S. NIH Grant/Contract )
R01MH069619 ( U.S. NIH Grant/Contract )
R01MH058356 ( U.S. NIH Grant/Contract )
R01MH069618 ( U.S. NIH Grant/Contract )
First Submitted: July 6, 2005
First Posted: July 11, 2005
Results First Submitted: December 12, 2013
Results First Posted: June 5, 2014
Last Update Posted: June 5, 2014