Cognitive Therapy for Recurrent Depression

This study has been completed.
Sponsor:
Collaborator:
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
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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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.
523 adults with recurrent major depressive disorder began acute phase cognitive therapy; only the 241 eligible higher-risk responders were randomized to the 3 arms above.

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.

Total Total of all reporting groups

Baseline Measures
    Continuation Phase Fluoxetine     Continuation Phase Cognitive Therapy     Continuation Phase Pill Placebo     Total  
Number of Participants  
[units: participants]
  86     86     69     241  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     86     86     69     241  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.6  ± 11.8     43.1  ± 11.5     43.6  ± 12.3     42.7  ± 11.8  
Gender  
[units: participants]
       
Female     57     63     42     162  
Male     29     23     27     79  
Region of Enrollment  
[units: participants]
       
United States     86     86     69     241  



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

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

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


  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

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.



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