Trial Outcomes & Findings for TRIAD - Treatment of Insomnia and Depression (NCT NCT00767624)

NCT ID: NCT00767624

Last Updated: 2016-12-05

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 150 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2016-12-05

Participant Flow

Participant milestones

Measure	Antidepressant + Desensitization 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	Antidepressant + Cognitive Behavioral 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 Study STARTED	75	75
Overall Study COMPLETED	51	58
Overall Study NOT COMPLETED	24	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TRIAD - Treatment of Insomnia and Depression

Baseline characteristics by cohort

Measure	Antidepressant + Desensitization n=75 Participants 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	Antidepressant + Cognitive Behavioral n=75 Participants 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 n=150 Participants Total of all reporting groups
Age, Continuous	45.0 years STANDARD_DEVIATION 12.3 • n=5 Participants	48.3 years STANDARD_DEVIATION 12.7 • n=7 Participants	46.6 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	53 Participants n=7 Participants	110 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Insomnia Severity Index (ISI)	18.3 units on a scale STANDARD_DEVIATION 3.9 • n=5 Participants	19.4 units on a scale STANDARD_DEVIATION 4.3 • n=7 Participants	18.9 units on a scale STANDARD_DEVIATION 4.1 • n=5 Participants
Hamilton Rating Scale for Depression (HRSD)	21.5 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants	21.9 units on a scale STANDARD_DEVIATION 3.8 • n=7 Participants	21.7 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

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

Outcome measures

Measure	Antidepressant + Desensitization n=75 Participants 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	Antidepressant + Cognitive Behavioral n=75 Participants 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
Percent of Participants With Depression Remission	36.0 percentage of participants in arm	43.8 percentage of participants in arm

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Antidepressant + Desensitization n=75 Participants 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	Antidepressant + Cognitive Behavioral n=75 Participants 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
Percentage of Participants in Insomnia Remission	29 percentage of particpants in arm	54 percentage of particpants in arm

Adverse Events

Antidepressant + Desensitization

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Antidepressant + Cognitive Behavioral

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Antidepressant + Desensitization n=75 participants at risk 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	Antidepressant + Cognitive Behavioral n=75 participants at risk 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
Psychiatric disorders suicidal ideation and worsening depression	0.00% 0/75	1.3% 1/75
Cardiac disorders Worsening of known cardiac condition	0.00% 0/75	1.3% 1/75
Reproductive system and breast disorders Severe vaginal bleeding and pain	1.3% 1/75	0.00% 0/75
Cardiac disorders Chest pain in a patient with CAD	1.3% 1/75	0.00% 0/75
Respiratory, thoracic and mediastinal disorders Asthma	1.3% 1/75	0.00% 0/75
Blood and lymphatic system disorders Hematoma R side abdomen	1.3% 1/75	0.00% 0/75

Other adverse events

Measure	Antidepressant + Desensitization n=75 participants at risk 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	Antidepressant + Cognitive Behavioral n=75 participants at risk 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
Injury, poisoning and procedural complications Medically significant event not requiring hospitalization	0.00% 0/75	1.3% 1/75

Additional Information

Rachel Manber, PhD

STANFORD UNIVERSITY

Phone: 6504981266

Email: rmanber@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place