Depression-Diabetes Mechanisms: Urban African Americans
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|ClinicalTrials.gov Identifier: NCT00209170|
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : July 29, 2015
Last Update Posted : July 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Depression||Behavioral: Beating the Blues Drug: Escitalopram Drug: Placebo||Phase 4|
To determine the psychobehavioral and neurohormonal mechanisms of effective treatment, the investigator will conduct a randomized, double-blind, placebo-controlled trial in patients with major depression, who will receive either: (i) computer-based cognitive behavioral therapy (CBT) program entitled "Beating the Blues" + placebo, or (ii) computer-based cognitive behavioral therapy (CBT) program entitled "Beating the Blues" + the SSRI antidepressant escitalopram. The investigator will assess (a) glycemic control (levels of glycated hemoglobin (HbA1c)), in relation to (b) adherence (keeping scheduled return appointments, diet, exercise, and glucose monitoring), (c) depressive symptoms (neurocognitive and neurobehavioral symptoms determined by self- and observer-rated scales), and (d) the four pathways of neurometabolic function.
Study visits will occur once a month for 6 months. Should patients report severe environmental stressors (such as marital conflict, loss of family member or job, being exposed to trauma), patients will be offered an intensification of their contact with study personnel, e.g. weekly contact by phone or "in-person" visits to see study personnel at the Grady Diabetes Clinic.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Depression-Diabetes Mechanisms: Urban African Americans|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
Experimental: Beating the Blues CBT + Escitalopram
Subjects with type 2 diabetes will be randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
Behavioral: Beating the Blues
Beating the Blues is a computerized cognitive behavioral therapy.Drug: Escitalopram
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It's a 10 mg pill taken once or twice daily for 6 months.
Other Name: Lexapro
Active Comparator: Beating the Blues CBT + Placebo
Subjects with type 2 diabetes will be randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
Behavioral: Beating the Blues
Beating the Blues is a computerized cognitive behavioral therapy.Drug: Placebo
A sugar pill taken as one to two tablets daily for 6 months.
- Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24 [ Time Frame: Baseline, week 24 ]
The 21-item HDRS measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60, where higher scores indicate greater severity. The HDRS at week 24 was compared to the baseline HDRS and each participant's response was calculated using the below table:
No Response = < 25% change in Depression Rating Scale Score Partial Responder =< 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209170
|United States, Georgia|
|Grady Hospital Diabetes Clinic|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Dominique L Musselman, MD, MS||Emory University|