Trial Outcomes & Findings for Depression-Diabetes Mechanisms: Urban African Americans (NCT NCT00209170)

NCT ID: NCT00209170

Last Updated: 2015-07-29

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Baseline, week 24

Results posted on

2015-07-29

Participant Flow

The study consented 20 subjects, but 6 subjects were not randomized into treatment groups because they were lost to follow-up.

Participant milestones

Participant milestones
Measure	Beating the Blues CBT + Escitalopram 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	Beating the Blues CBT + Placebo 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 Study STARTED	7	7
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Beating the Blues CBT + Escitalopram 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	Beating the Blues CBT + Placebo 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 Study Adverse Event	0	1
Overall Study Withdrawal by Subject	2	1
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

Depression-Diabetes Mechanisms: Urban African Americans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Beating the Blues CBT + Escitalopram n=7 Participants 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	Beating the Blues CBT + Placebo n=7 Participants 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 n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=39 Participants	7 Participants n=41 Participants	14 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Sex: Female, Male Female	7 Participants n=39 Participants	5 Participants n=41 Participants	12 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	2 Participants n=41 Participants	2 Participants n=35 Participants

PRIMARY outcome

Timeframe: Baseline, week 24

Population: Last Observation Carried Forward

Outcome measures

Outcome measures
Measure	Beating the Blues CBT + Escitalopram n=7 Participants 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	Beating the Blues CBT + Placebo n=7 Participants 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
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24 Response	2 participants	1 participants
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24 Partial Response	2 participants	1 participants
Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24 No Response	3 participants	5 participants

Adverse Events

Beating the Blues CBT + Escitalopram

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Beating the Blues CBT + Placebo

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Beating the Blues CBT + Escitalopram n=7 participants at risk 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	Beating the Blues CBT + Placebo n=7 participants at risk 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
Psychiatric disorders Suicide attempt using insulin	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Number of events 1 • Adverse event data collected up to 6 months
Respiratory, thoracic and mediastinal disorders Exacerbation of asthma	14.3% 1/7 • Number of events 1 • Adverse event data collected up to 6 months	0.00% 0/7 • Adverse event data collected up to 6 months
Endocrine disorders Diabetic ketoacidosis	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Number of events 1 • Adverse event data collected up to 6 months

Other adverse events

Additional Information

Dominique Musselman, MD

University of Miami School of Medicine

Phone: 404-723-8361

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Beating the Blues CBT + Escitalopram n=7 participants at risk 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	Beating the Blues CBT + Placebo n=7 participants at risk 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
Cardiac disorders Chest tightness	28.6% 2/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Cardiac disorders Orthostatic tachycardia	14.3% 1/7 • Adverse event data collected up to 6 months	28.6% 2/7 • Adverse event data collected up to 6 months
Musculoskeletal and connective tissue disorders Joint Pain	14.3% 1/7 • Adverse event data collected up to 6 months	42.9% 3/7 • Adverse event data collected up to 6 months
Nervous system disorders Sedation	28.6% 2/7 • Adverse event data collected up to 6 months	0.00% 0/7 • Adverse event data collected up to 6 months
Reproductive system and breast disorders Sexual dysfunction	14.3% 1/7 • Adverse event data collected up to 6 months	0.00% 0/7 • Adverse event data collected up to 6 months
Skin and subcutaneous tissue disorders Sweating	14.3% 1/7 • Adverse event data collected up to 6 months	28.6% 2/7 • Adverse event data collected up to 6 months
Metabolism and nutrition disorders Weight gain	0.00% 0/7 • Adverse event data collected up to 6 months	28.6% 2/7 • Adverse event data collected up to 6 months
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • Adverse event data collected up to 6 months	28.6% 2/7 • Adverse event data collected up to 6 months
Gastrointestinal disorders Constipation	14.3% 1/7 • Adverse event data collected up to 6 months	0.00% 0/7 • Adverse event data collected up to 6 months
Gastrointestinal disorders Edema	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
General disorders Fatigue	0.00% 0/7 • Adverse event data collected up to 6 months	28.6% 2/7 • Adverse event data collected up to 6 months
Injury, poisoning and procedural complications Fall	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Renal and urinary disorders Frequent urination	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Nervous system disorders Headache	42.9% 3/7 • Adverse event data collected up to 6 months	71.4% 5/7 • Adverse event data collected up to 6 months
Cardiac disorders Elevated blood pressure	28.6% 2/7 • Adverse event data collected up to 6 months	28.6% 2/7 • Adverse event data collected up to 6 months
General disorders Insomnia	42.9% 3/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Nervous system disorders Memory Difficulties	14.3% 1/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Gastrointestinal disorders Nausea	14.3% 1/7 • Adverse event data collected up to 6 months	42.9% 3/7 • Adverse event data collected up to 6 months
Ear and labyrinth disorders Nose bleed	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Cardiac disorders Orthostatic hypotension	14.3% 1/7 • Adverse event data collected up to 6 months	28.6% 2/7 • Adverse event data collected up to 6 months
Musculoskeletal and connective tissue disorders Numbness	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Psychiatric disorders Panic attack	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Infections and infestations Pneumonia	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Renal and urinary disorders Polyuria	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Skin and subcutaneous tissue disorders Rash	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Ear and labyrinth disorders Sinus Congestion	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Cardiac disorders Tachycardia	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Ear and labyrinth disorders Tinnitus	14.3% 1/7 • Adverse event data collected up to 6 months	0.00% 0/7 • Adverse event data collected up to 6 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tooth abscess	0.00% 0/7 • Adverse event data collected up to 6 months	14.3% 1/7 • Adverse event data collected up to 6 months
Cardiac disorders Dyspnea	28.6% 2/7 • Adverse event data collected up to 6 months	42.9% 3/7 • Adverse event data collected up to 6 months