Sleep Initiation and Maintenance Disorders, Depression
Conditions
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.
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.
Interventions
DRUGAntidepressant
Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
BEHAVIORALDesensitization Therapy for Insomnia
BEHAVIORALCognitive Behavioral Therapy for Insomnia
Sponsors
Duke University
University of Pittsburgh
University of Pennsylvania
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Depression Remission | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 75 |
| 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 | 75 |
| Total | 150 |
Baseline characteristics
| Characteristic | Antidepressant + Desensitization | Antidepressant + Cognitive Behavioral | Total |
|---|---|---|---|
| Age, Continuous | 45.0 years STANDARD_DEVIATION 12.3 | 48.3 years STANDARD_DEVIATION 12.7 | 46.6 years STANDARD_DEVIATION 12.6 |
| Hamilton Rating Scale for Depression (HRSD) | 21.5 units on a scale STANDARD_DEVIATION 3.7 | 21.9 units on a scale STANDARD_DEVIATION 3.8 | 21.7 units on a scale STANDARD_DEVIATION 3.7 |
| Insomnia Severity Index (ISI) | 18.3 units on a scale STANDARD_DEVIATION 3.9 | 19.4 units on a scale STANDARD_DEVIATION 4.3 | 18.9 units on a scale STANDARD_DEVIATION 4.1 |
| Sex: Female, Male Female | 57 Participants | 53 Participants | 110 Participants |
| Sex: Female, Male Male | 18 Participants | 22 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 75 | 1 / 75 |
| serious Total, serious adverse events | 3 / 75 | 2 / 75 |
Outcome results
Primary
Percent of Participants With Depression Remission
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antidepressant + Desensitization | Percent of Participants With Depression Remission | 36.0 percentage of participants in arm |
| Antidepressant + Cognitive Behavioral | Percent of Participants With Depression Remission | 43.8 percentage of participants in arm |
Secondary
Percentage of Participants in Insomnia Remission
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antidepressant + Desensitization | Percentage of Participants in Insomnia Remission | 29 percentage of particpants in arm |
| Antidepressant + Cognitive Behavioral | Percentage of Participants in Insomnia Remission | 54 percentage of particpants in arm |