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Trial record 27 of 47 for:    DESIPRAMINE

Depression, Epinephrine, and Platelet Function

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ClinicalTrials.gov Identifier: NCT00166114
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dominique Musselman, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Escitalopram
Drug: Desipramine
Enrollment 40
Recruitment Details Subjects recruited from Emory Psychiatry Clinic outpatient population
Pre-assignment Details  
Arm/Group Title Escitalopram Desipramine
Hide Arm/Group Description Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56 Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
Period Title: Overall Study
Started 21 19
Completed 7 13
Not Completed 14 6
Reason Not Completed
Protocol Violation             2             1
Withdrawal by Subject             10             4
Adverse Event             2             1
Arm/Group Title Escitalopram Desipramine Total
Hide Arm/Group Description Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 until day 56 Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention Total of all reporting groups
Overall Number of Baseline Participants 21 19 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
19
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Age, Categorical
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
Female
8
  38.1%
6
  31.6%
14
  35.0%
Male
13
  61.9%
13
  68.4%
26
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 19 participants 40 participants
21 19 40
1.Primary Outcome
Title Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8
Hide Description

Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8.

The 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 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 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram Desipramine
Hide Arm/Group Description:
Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
Overall Number of Participants Analyzed 7 13
Measure Type: Number
Unit of Measure: participants
Response 5 9
No or Partial Response 2 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram
Comments Chi Square test was performed comparing actual vs. expected non- and partial response or response to either escitalopram or desipramine treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .918
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Desipramine
Hide Arm/Group Description 10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention 25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
All-Cause Mortality
Escitalopram Desipramine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Desipramine
Affected / at Risk (%) Affected / at Risk (%)
Total   1/21 (4.76%)   0/19 (0.00%) 
Psychiatric disorders     
Suicide gesture (superficial lacerations to wrists with a razor)   1/21 (4.76%)  0/19 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Escitalopram Desipramine
Affected / at Risk (%) Affected / at Risk (%)
Total   13/21 (61.90%)   18/19 (94.74%) 
Cardiac disorders     
Orthostatic Tachycardia   0/21 (0.00%)  1/19 (5.26%) 
Gastrointestinal disorders     
Heartburn *  1/21 (4.76%)  0/19 (0.00%) 
Constipation *  0/21 (0.00%)  2/19 (10.53%) 
Stomach Pain *  0/21 (0.00%)  1/19 (5.26%) 
Indigestion *  1/21 (4.76%)  1/19 (5.26%) 
Infections and infestations     
Upper Respiratory Infection *  1/21 (4.76%)  1/19 (5.26%) 
Metabolism and nutrition disorders     
Increased Liver Function Test *  0/21 (0.00%)  1/19 (5.26%) 
Weight Loss   0/21 (0.00%)  1/19 (5.26%) 
Nervous system disorders     
Headache *  3/21 (14.29%)  3/19 (15.79%) 
Sedation *  1/21 (4.76%)  0/19 (0.00%) 
Fatigue *  2/21 (9.52%)  0/19 (0.00%) 
Insomnia *  0/21 (0.00%)  1/19 (5.26%) 
Confusion *  1/21 (4.76%)  0/19 (0.00%) 
Irritability *  1/21 (4.76%)  0/19 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy   0/21 (0.00%)  1/19 (5.26%) 
Reproductive system and breast disorders     
Ejaculation Disorder *  0/21 (0.00%)  1/19 (5.26%) 
Skin and subcutaneous tissue disorders     
Dry Mouth   2/21 (9.52%)  2/19 (10.53%) 
Rash   0/21 (0.00%)  1/19 (5.26%) 
Pruritis *  0/21 (0.00%)  1/19 (5.26%) 
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
Layout table for Results Point of Contact information
Name/Title: Dominique Musselman, MD, MSCR
Organization: University of Miami School of Medicine
Phone: 404-723-8361
EMail: dmusselman@med.miami.edu
Layout table for additonal information
Responsible Party: Dominique Musselman, Emory University
ClinicalTrials.gov Identifier: NCT00166114     History of Changes
Other Study ID Numbers: 0473-2002
1R01HL065523-01A2 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 14, 2005
Results First Submitted: December 9, 2013
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015