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Trial record 8 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Dominique Musselman, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Diabetes
Depression
Interventions Behavioral: Beating the Blues
Drug: Escitalopram
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details The study consented 20 subjects, but 6 subjects were not randomized into treatment groups because they were lost to follow-up.
Arm/Group Title Beating the Blues CBT + Escitalopram Beating the Blues CBT + Placebo
Hide Arm/Group Description Subjects with type 2 diabetes 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 Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
Period Title: Overall Study
Started 7 7
Completed 5 4
Not Completed 2 3
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             2             1
Lack of Efficacy             0             1
Arm/Group Title Beating the Blues CBT + Escitalopram Beating the Blues CBT + Placebo Total
Hide Arm/Group Description Subjects with type 2 diabetes 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 Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
7
 100.0%
14
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
7
 100.0%
5
  71.4%
12
  85.7%
Male
0
   0.0%
2
  28.6%
2
  14.3%
1.Primary Outcome
Title Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24
Hide Description

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

Time Frame Baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward
Arm/Group Title Beating the Blues CBT + Escitalopram Beating the Blues CBT + Placebo
Hide Arm/Group Description:
Subjects with type 2 diabetes 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
Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
Overall Number of Participants Analyzed 7 7
Measure Type: Number
Unit of Measure: participants
Response 2 1
Partial Response 2 1
No Response 3 5
Time Frame Adverse event data collected up to 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Beating the Blues CBT + Escitalopram Beating the Blues CBT + Placebo
Hide Arm/Group Description Subjects with type 2 diabetes 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 Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
All-Cause Mortality
Beating the Blues CBT + Escitalopram Beating the Blues CBT + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Beating the Blues CBT + Escitalopram Beating the Blues CBT + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      2/7 (28.57%)    
Endocrine disorders     
Diabetic ketoacidosis *  0/7 (0.00%)  0 1/7 (14.29%)  1
Psychiatric disorders     
Suicide attempt using insulin *  0/7 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders     
Exacerbation of asthma *  1/7 (14.29%)  1 0/7 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Beating the Blues CBT + Escitalopram Beating the Blues CBT + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/7 (100.00%)      7/7 (100.00%)    
Cardiac disorders     
Chest tightness *  2/7 (28.57%)  1/7 (14.29%) 
Orthostatic tachycardia   1/7 (14.29%)  2/7 (28.57%) 
Elevated blood pressure *  2/7 (28.57%)  2/7 (28.57%) 
Orthostatic hypotension *  1/7 (14.29%)  2/7 (28.57%) 
Tachycardia *  0/7 (0.00%)  1/7 (14.29%) 
Dyspnea *  2/7 (28.57%)  3/7 (42.86%) 
Ear and labyrinth disorders     
Nose bleed *  0/7 (0.00%)  1/7 (14.29%) 
Sinus Congestion *  0/7 (0.00%)  1/7 (14.29%) 
Tinnitus *  1/7 (14.29%)  0/7 (0.00%) 
Gastrointestinal disorders     
Constipation *  1/7 (14.29%)  0/7 (0.00%) 
Edema *  0/7 (0.00%)  1/7 (14.29%) 
Nausea *  1/7 (14.29%)  3/7 (42.86%) 
General disorders     
Fatigue *  0/7 (0.00%)  2/7 (28.57%) 
Insomnia *  3/7 (42.86%)  1/7 (14.29%) 
Infections and infestations     
Pneumonia *  0/7 (0.00%)  1/7 (14.29%) 
Injury, poisoning and procedural complications     
Fall *  0/7 (0.00%)  1/7 (14.29%) 
Metabolism and nutrition disorders     
Weight gain   0/7 (0.00%)  2/7 (28.57%) 
Musculoskeletal and connective tissue disorders     
Joint Pain *  1/7 (14.29%)  3/7 (42.86%) 
Back pain *  0/7 (0.00%)  2/7 (28.57%) 
Numbness *  0/7 (0.00%)  1/7 (14.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tooth abscess *  0/7 (0.00%)  1/7 (14.29%) 
Nervous system disorders     
Sedation *  2/7 (28.57%)  0/7 (0.00%) 
Headache *  3/7 (42.86%)  5/7 (71.43%) 
Memory Difficulties *  1/7 (14.29%)  1/7 (14.29%) 
Psychiatric disorders     
Panic attack *  0/7 (0.00%)  1/7 (14.29%) 
Renal and urinary disorders     
Frequent urination *  0/7 (0.00%)  1/7 (14.29%) 
Polyuria *  0/7 (0.00%)  1/7 (14.29%) 
Reproductive system and breast disorders     
Sexual dysfunction *  1/7 (14.29%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders     
Sweating *  1/7 (14.29%)  2/7 (28.57%) 
Rash *  0/7 (0.00%)  1/7 (14.29%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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: Dominique Musselman, MD
Organization: University of Miami School of Medicine
Phone: 404-723-8361
Responsible Party: Dominique Musselman, Emory University
ClinicalTrials.gov Identifier: NCT00209170     History of Changes
Other Study ID Numbers: IRB00001092
R01MH069254-03 ( U.S. NIH Grant/Contract )
First Submitted: September 14, 2005
First Posted: September 21, 2005
Results First Submitted: June 23, 2015
Results First Posted: July 29, 2015
Last Update Posted: July 29, 2015