TRIAD - Treatment of Insomnia and Depression

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00767624
• Collaborator: Duke University (Other), University of Pittsburgh (Other), University of Pennsylvania (Other)
• Enrollment: 150
• Locations: 3
• Arms: 2
• Duration (Months): 78
• Patients Per Site: 50
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia.

Condition or Disease	Intervention/Treatment	Phase
Sleep Initiation and Maintenance Disorders; Depression	Drug: Antidepressant; Behavioral: Desensitization Therapy for Insomnia; Behavioral: Cognitive Behavioral Therapy for Insomnia	Phase 2/Phase 3

Detailed Description

Participants with major depressive disorder and insomnia who meet all study criteria will receive state-of-the-art antidepressant medications and one of two insomnia therapies. The specific therapy for insomnia will be determined by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or desensitization psychotherapy for insomnia. The study physician will select an initial antidepressant medication from a list of three possible medications . If that medication is not helpful, another medication may be tried after 8 weeks or in the event of severe side effects.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: antidepressant + desensitization Combined antidepressant medication (determined by an algorithm) plus desensitization therapy	Drug: Antidepressant; Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance; Behavioral: Desensitization Therapy for Insomnia
Other: antidepressant + cognitive behavioral Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy	Drug: Antidepressant; Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance; Behavioral: Cognitive Behavioral Therapy for Insomnia

Outcome Measures

Primary Outcome Measures

1. Percent of Participants With Depression Remission [16 weeks]

   Depression remission was defined if both a and b below are satisfied absence of both depressed mood and anhedonia for at least three consecutive weeks no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks

Secondary Outcome Measures

1. Percentage of Participants in Insomnia Remission [16 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Meets criteria for Major Depressive Disorder

2. Between 18 and 75 years of age and adequately fluent in English

3. Meets criteria for an insomnia disorder

Exclusion Criteria:

1. Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.

2. People for whom the antidepressant medication(s) provided in the study is not indicated

3. People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.

4. People with uncontrolled medical conditions.

5. People with moderate or severe sleep disorders other than insomnia

6. Individuals on a fixed night shift or rotating work schedule that requires a night shift.

7. Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305
2	Duke University	Durham	North Carolina	United States
3	University of Pittsburgh	Pittsburgh	Pennsylvania	United States

Sponsors and Collaborators

• Stanford University
• Duke University
• University of Pittsburgh
• University of Pennsylvania

Investigators

• Principal Investigator: Rachel Manber, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rachel Manber, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT00767624
• Other Study ID Numbers: SU-08132008-1277; MH78924
• First Posted: Oct 7, 2008
• Last Update Posted: Dec 5, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder; Antidepressive Agents

Study Results

Participant Flow

Arm/Group Title	Antidepressant + Desensitization	Antidepressant + Cognitive Behavioral
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

Baseline Characteristics

Arm/Group Title	Antidepressant + Desensitization	Antidepressant + Cognitive Behavioral	Total
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 Participants	75	75	150
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.0 (12.3)	48.3 (12.7)	46.6 (12.6)
Sex: Female, Male (Count of Participants)
Female	57 76%	53 70.7%	110 73.3%
Male	18 24%	22 29.3%	40 26.7%
Insomnia Severity Index (ISI) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.3 (3.9)	19.4 (4.3)	18.9 (4.1)
Hamilton Rating Scale for Depression (HRSD) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	21.5 (3.7)	21.9 (3.8)	21.7 (3.7)

Outcome Measures

1. Primary Outcome

Title	Percent of Participants With Depression Remission
Description	Depression remission was defined if both a and b below are satisfied absence of both depressed mood and anhedonia for at least three consecutive weeks no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Antidepressant + Desensitization	Antidepressant + Cognitive Behavioral
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
Measure Participants	75	75
Number [percentage of participants in arm]	36.0 48%	43.8 58.4%

2. Secondary Outcome

Title	Percentage of Participants in Insomnia Remission
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Antidepressant + Desensitization	Antidepressant + Cognitive Behavioral
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
Measure Participants	75	75
Number [percentage of particpants in arm]	29	54

Adverse Events

Arm/Group Title	Antidepressant + Desensitization		Antidepressant + Cognitive Behavioral
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Antidepressant + Desensitization		Antidepressant + Cognitive Behavioral
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/75 (4%)		2/75 (2.7%)
Blood and lymphatic system disorders
Hematoma R side abdomen	1/75 (1.3%)		0/75 (0%)
Cardiac disorders
Worsening of known cardiac condition	0/75 (0%)		1/75 (1.3%)
Chest pain in a patient with CAD	1/75 (1.3%)		0/75 (0%)
Psychiatric disorders
suicidal ideation and worsening depression	0/75 (0%)		1/75 (1.3%)
Reproductive system and breast disorders
Severe vaginal bleeding and pain	1/75 (1.3%)		0/75 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/75 (1.3%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	Antidepressant + Desensitization		Antidepressant + Cognitive Behavioral
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		1/75 (1.3%)
Injury, poisoning and procedural complications
Medically significant event not requiring hospitalization	0/75 (0%)		1/75 (1.3%)

Limitations/Caveats

Our results do not inform clinical guidelines for any single antidepressant medication.

More Information

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.