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
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Study Type: | Interventional |
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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 |

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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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 |
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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 | |
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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 | |
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STARTED | 86 | 86 | 69 |
COMPLETED | 62 | 70 | 49 |
NOT COMPLETED | 24 | 16 | 20 |


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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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. |

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:
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 |