Trial Outcomes & Findings for Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome (NCT NCT00149825)

Results Overview

Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID. The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms. The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

After 12 weeks or at the last available time point

Results posted on

2014-05-20

Participant Flow

Participants were recruited between June 2004 and August 2006 through newspaper advertisements, electronic bulletin boards, community postings, and brochures in clinics.

Enrolled participants were screened to determine if inclusion exclusion criteria were met. This process included structured clinical interviews, completion of sleep logs, and an ambulatory screening sleep study to rule out other sleep disorders.

Participant milestones

Participant milestones
Measure	MED+CBTI Escitalopram plus cognitive behavioral therapy for insomnia	MED+CTRL Escitalopram plus control therapy for insomnia in depression
Overall Study STARTED	15	15
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	MED+CBTI Escitalopram plus cognitive behavioral therapy for insomnia	MED+CTRL Escitalopram plus control therapy for insomnia in depression
Overall Study Intolerance to medication side effects	1	2
Overall Study Time commitments	2	1
Overall Study Not liking insomnia therapy	1	0
Overall Study Other	1	0

Baseline Characteristics

Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MED+CBTI n=15 Participants Escitalopram plus cognitive behavioral therapy for insomnia	MED+CTRL n=15 Participants Escitalopram plus control therapy for insomnia in depression	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants	13 Participants n=4 Participants	27 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Age, Continuous	49.5 years STANDARD_DEVIATION 13.6 • n=93 Participants	47.8 years STANDARD_DEVIATION 13.4 • n=4 Participants	48.6 years STANDARD_DEVIATION 13.3 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	10 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	15 participants n=4 Participants	30 participants n=27 Participants

PRIMARY outcome

Timeframe: After 12 weeks or at the last available time point

Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID. The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms. The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains).

Outcome measures

Outcome measures
Measure	MED+CBTI n=13 Participants Escitalopram plus cognitive behavioral therapy for insomnia	MED+CTRL n=15 Participants Escitalopram plus control therapy for insomnia in depression
Remission of Depression (%)	61.5 percent of participants	33.3 percent of participants

SECONDARY outcome

Timeframe: After 12 weeks or at the last available time point

Population: Included in the analysis were all participants who attended at least one post randomization visit.

Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score \< 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score \< 8 indicates absence of insomnia.

Outcome measures

Outcome measures
Measure	MED+CBTI n=13 Participants Escitalopram plus cognitive behavioral therapy for insomnia	MED+CTRL n=15 Participants Escitalopram plus control therapy for insomnia in depression
Remission of Insomnia	50.0 percent	7.7 percent

Adverse Events

MED+CBTI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MED+CTRL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Manber, PhD

Stanford University, School of Medicine

Phone: 650-724-2377

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place