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Sequential Treatment of Pediatric MDD to Increase Remission and Prevent Relapse

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Graham Emslie, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00612313
First received: February 7, 2008
Last updated: December 3, 2015
Last verified: December 2015
Results First Received: July 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Fluoxetine
Behavioral: Relapse prevention cognitive behavioral therapy (CBT)

  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
200 participants began acute phase open-label treatment with fluoxetine. Of these, 144 entered the randomized control study. Results data presented are for 144 participants randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Continued Medication Alone

n=69 Participants will receive antidepressant treatment with fluoxetine for 30 weeks

Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.

Continued Medication Plus CBT

n=75 Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment

Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.

Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms.


Participant Flow:   Overall Study
    Continued Medication Alone   Continued Medication Plus CBT
STARTED   69   75 
COMPLETED   52   62 
NOT COMPLETED   17   13 
Withdrawal by Subject                6                9 
Lost to Follow-up                11                4 



  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.
No text entered.

Reporting Groups
  Description
Continued Medication Alone

Participants received antidepressant treatment with fluoxetine for 30 weeks

Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.

Continued Medication Plus CBT

Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment

Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.

Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants attended 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms.

Total Total of all reporting groups

Baseline Measures
   Continued Medication Alone   Continued Medication Plus CBT   Total 
Overall Participants Analyzed 
[Units: Participants]
 69   75   144 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.2  (2.4)   13.5  (2.7)   13.8  (2.6) 
Gender 
[Units: Participants]
     
Female   39   38   77 
Male   30   37   67 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   20   23   43 
Not Hispanic or Latino   49   52   101 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   0   1   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   7   8   15 
White   54   64   118 
More than one race   7   2   9 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   69   75   144 
Baseline CDRS-R [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 59.2  (7.0)   56.8  (7.1)   58.0  (7.2) 
[1]

Childhood Depression Rating Scale - Revised (CDRS-R) Total score range: 17-113

Scoring thresholds:

>=40: moderate to severe depression; <=28: remission

Baseline CGI Severity [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.3  (0.69)   5.1  (0.7)   5.2  (0.7) 
[1]

Clinical Global Impression - Severity Range: 1-7

  1. Normal, not at all ill
  2. Borderline mentally ill
  3. Mildly ill
  4. Moderately ill
  5. Markedly ill
  6. Severly ill
  7. Among the most extremely ill patients


  Outcome Measures
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1.  Primary:   Time to Remission   [ Time Frame: 30 weeks ]

2.  Primary:   Relapse   [ Time Frame: Measured at Weeks 12, 18, 24, and 30 ]

3.  Primary:   Remission   [ Time Frame: Measured at Weeks 12, 18, 24, and 30 ]

4.  Secondary:   K-Life (Time Well)   [ Time Frame: 30 weeks ]

5.  Secondary:   Remission   [ Time Frame: Weeks 52 and 78 ]

6.  Secondary:   Relapse   [ Time Frame: Weeks 52 and 78 ]


  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
  • Primary outcomes based on data through 30 weeks.
  • Participants were not blinded to treatment assignment.


  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. Graham Emslie and Dr. Betsy Kennard
Organization: UT Southwestern Medical Center
phone: 214-456-5900
e-mail: beth.kennard@utsouthwestern.edu


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

Responsible Party: Graham Emslie, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00612313     History of Changes
Obsolete Identifiers: NCT00599300
Other Study ID Numbers: R01MH039188-01 ( US NIH Grant/Contract Award Number )
DSIR 84-CTS
Study First Received: February 7, 2008
Results First Received: July 3, 2014
Last Updated: December 3, 2015
Health Authority: United States: Federal Government