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Augmenting Antidepressant Treatment With Interpersonal Psychotherapy for Treating Late-life Depression

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177294
First received: September 12, 2005
Last updated: January 10, 2012
Last verified: November 2010
History of Changes
Results First Received: December 22, 2010  
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: Escitalopram
Behavioral: Interpersonal Psychotherapy
Behavioral: Clinical Monitoring

  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
Participants were recruited from primary care and specialty mental-health clinics. 377 participants signed consent; 319 started study treatment; 124 were randomized. Of the 124 participants, 60 were randomized to Interpersonal Psychotherapy (IPT) and 59 randomized to Depression Care Management(DCM) without IPT.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
67 enrolled participants were not randomized due to the following reasons: consent withdrawal (41); did not meet eligibility criteria (16); supervening medical problems that precluded participation (4); past history of non-reponse to escitalopram (1); side effects (1).

Reporting Groups
  Description
Escitalopram Plus Interpersonal Psychotherapy (IPT) Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
Escitalopram Plus Depression Care Management (DCM) Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)

Participant Flow:   Overall Study
    Escitalopram Plus Interpersonal Psychotherapy (IPT)     Escitalopram Plus Depression Care Management (DCM)  
STARTED     60     64  
COMPLETED     53     59  
NOT COMPLETED     7     5  
Withdrawal by Subject                 7                 5  



  Baseline Characteristics
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Reporting Groups
  Description
Escitalopram Plus Interpersonal Psychotherapy (IPT) Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
Escitalopram Plus Depression Care Management (DCM) Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
Total Total of all reporting groups

Baseline Measures
    Escitalopram Plus Interpersonal Psychotherapy (IPT)     Escitalopram Plus Depression Care Management (DCM)     Total  
Number of Participants  
[units: participants]
 		  60     64     124  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     11     9     20  
>=65 years     49     55     104  
Age  
[units: years]
Mean ± Standard Deviation 		  71.1  ± 7.1     73.4  ± 7.7     72.27  ± 7.51  
Gender  
[units: participants]
 		     
Female     44     41     85  
Male     16     23     39  
Region of Enrollment  
[units: participants]
 		     
United States     60     64     124  



  Outcome Measures

1.  Primary:   Remission   [ Time Frame: Measured at Week 6 or 22 ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  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.


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
The study design does not allow an inference about which specific intervention led to further improvement. Was it simply a dose increase of escitalopram from 10mg to 20mg? Is this intensive contact necessary for improvement?  


Results Point of Contact:  
Name/Title: Charles F. Reynolds III, MD
Organization: University of Pittsburgh
phone: 412-246-6414
e-mail: reynoldscf@upmc.edu


Publications of Results:


Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177294     History of Changes
Other Study ID Numbers: R01 MH037869-01, R01MH037869, 0404007, DATR A4-GPS
Study First Received: September 12, 2005
Results First Received: December 22, 2010
Last Updated: January 10, 2012
Health Authority: United States: Federal Government