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Trial record 74 of 89 for:    DESVENLAFAXINE

TRIAD - Treatment of Insomnia and Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00767624
Recruitment Status : Completed
First Posted : October 7, 2008
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Collaborators:
Duke University
University of Pittsburgh
University of Pennsylvania
Information provided by (Responsible Party):
Rachel Manber, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Sleep Initiation and Maintenance Disorders
Depression
Interventions Drug: Antidepressant
Behavioral: Desensitization Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Antidepressant + Desensitization Antidepressant + Cognitive Behavioral
Hide Arm/Group Description

Combined antidepressant medication (determined by an algorithm) plus desensitization therapy

Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Desensitization Therapy for Insomnia

Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy

Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Cognitive Behavioral Therapy for Insomnia

Period Title: Overall Study
Started 75 75
Completed 51 58
Not Completed 24 17
Arm/Group Title Antidepressant + Desensitization Antidepressant + Cognitive Behavioral Total
Hide Arm/Group Description

Combined antidepressant medication (determined by an algorithm) plus desensitization therapy

Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Desensitization Therapy for Insomnia

Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy

Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Cognitive Behavioral Therapy for Insomnia

Total of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
Intent to treat
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 75 participants 150 participants
45.0  (12.3) 48.3  (12.7) 46.6  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
57
  76.0%
53
  70.7%
110
  73.3%
Male
18
  24.0%
22
  29.3%
40
  26.7%
Insomnia Severity Index (ISI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 75 participants 75 participants 150 participants
18.3  (3.9) 19.4  (4.3) 18.9  (4.1)
[1]
Measure Description: The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28, with larger numbers representing greater severity. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8- 14); moderate insomnia (15-21); and severe insomnia (22-28).
Hamilton Rating Scale for Depression (HRSD)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 75 participants 75 participants 150 participants
21.5  (3.7) 21.9  (3.8) 21.7  (3.7)
[1]
Measure Description: The HRSD is a 17-item semi-structured interview assessing the severity of depression in the past week. Items are rated on a 3 or 5 point scale. The total score is the sum of individual items, yielding a total score ranging from 0 to 52, with larger numbers representing greater severity. The total score is interpreted as follows: absence of depression (0-7); mild depression (8- 16); moderate depression (17-23); and severe depression (24-52).
1.Primary Outcome
Title Percent of Participants With Depression Remission
Hide Description

Depression remission was defined if both a and b below are satisfied

  1. absence of both depressed mood and anhedonia for at least three consecutive weeks
  2. no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antidepressant + Desensitization Antidepressant + Cognitive Behavioral
Hide Arm/Group Description:

Combined antidepressant medication (determined by an algorithm) plus desensitization therapy

Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Desensitization Therapy for Insomnia

Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy

Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Cognitive Behavioral Therapy for Insomnia

Overall Number of Participants Analyzed 75 75
Measure Type: Number
Unit of Measure: percentage of participants in arm
36.0 43.8
2.Secondary Outcome
Title Percentage of Participants in Insomnia Remission
Hide Description Remission was defined as endpoint ISI<8. The ISI scale score ranges from 0 to 28 with lower scores representing less severe insomnia. A score of 0-7 is interpreted as absence of insomnia.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antidepressant + Desensitization Antidepressant + Cognitive Behavioral
Hide Arm/Group Description:

Combined antidepressant medication (determined by an algorithm) plus desensitization therapy

Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Desensitization Therapy for Insomnia

Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy

Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Cognitive Behavioral Therapy for Insomnia

Overall Number of Participants Analyzed 75 75
Measure Type: Number
Unit of Measure: percentage of particpants in arm
29 54
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Antidepressant + Desensitization Antidepressant + Cognitive Behavioral
Hide Arm/Group Description

Combined antidepressant medication (determined by an algorithm) plus desensitization therapy

Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Desensitization Therapy for Insomnia

Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy

Antidepressant: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Cognitive Behavioral Therapy for Insomnia

All-Cause Mortality
Antidepressant + Desensitization Antidepressant + Cognitive Behavioral
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Antidepressant + Desensitization Antidepressant + Cognitive Behavioral
Affected / at Risk (%) Affected / at Risk (%)
Total   3/75 (4.00%)   2/75 (2.67%) 
Blood and lymphatic system disorders     
Hematoma R side abdomen [1]  1/75 (1.33%)  0/75 (0.00%) 
Cardiac disorders     
Worsening of known cardiac condition [2]  0/75 (0.00%)  1/75 (1.33%) 
Chest pain in a patient with CAD [3]  1/75 (1.33%)  0/75 (0.00%) 
Psychiatric disorders     
suicidal ideation and worsening depression [4]  0/75 (0.00%)  1/75 (1.33%) 
Reproductive system and breast disorders     
Severe vaginal bleeding and pain [5]  1/75 (1.33%)  0/75 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma [6]  1/75 (1.33%)  0/75 (0.00%) 
[1]
Medical event requiring hospitalization The person experiencing this event had another SAE event
[2]
Medical event requiring hospitalization . Event was not expected and was not related to study meds
[3]
Medical event requiring hospitalization
[4]
Psychiatric event
[5]
Medical event requiring hospitalization.
[6]
Medical event requiring hospitalization The person experiencing this event had another serious adverse event
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Antidepressant + Desensitization Antidepressant + Cognitive Behavioral
Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   1/75 (1.33%) 
Injury, poisoning and procedural complications     
Medically significant event not requiring hospitalization [1]  0/75 (0.00%)  1/75 (1.33%) 
[1]
slipped on street curb and broke wrist
Our results do not inform clinical guidelines for any single antidepressant medication.
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: Rachel Manber, PhD
Organization: STANFORD UNIVERSITY
Phone: 6504981266
EMail: rmanber@stanford.edu
Layout table for additonal information
Responsible Party: Rachel Manber, Stanford University
ClinicalTrials.gov Identifier: NCT00767624     History of Changes
Other Study ID Numbers: SU-08132008-1277
MH78924
First Submitted: October 3, 2008
First Posted: October 7, 2008
Results First Submitted: August 5, 2016
Results First Posted: December 5, 2016
Last Update Posted: December 5, 2016