Trial Outcomes & Findings for Improving Sleep and Psychological Functioning in People With Depression and Insomnia (NCT NCT00247624)

Results Overview

The BASIS 32 psychometric includes several subscales, including "daily living and role functioning" (DLRF). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension and lower scores denoting better outcomes. Measured weekly for 9 weeks. Reported as mean of 9 weeks.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

9 weeks

Results posted on

2018-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Fluoxetine (FLX) Plus Eszopiclone (ESZ) Participants will receive treatment with eszopiclone and fluoxetine	FLX Plus Placebo Participants will receive treatment with placebo and fluoxetine
Overall Study STARTED	30	30
Overall Study COMPLETED	25	26
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Sleep and Psychological Functioning in People With Depression and Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluoxetine (FLX) Plus Eszopiclone (ESZ) n=30 Participants Participants will receive treatment with eszopiclone and fluoxetine	FLX Plus Placebo n=30 Participants Participants will receive treatment with placebo and fluoxetine	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	44.9 years STANDARD_DEVIATION 11.7 • n=5 Participants	38.0 years STANDARD_DEVIATION 12.5 • n=7 Participants	41.5 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
BASIS 32 DLRF	1.9 units STANDARD_DEVIATION 0.7 • n=5 Participants	2.0 units STANDARD_DEVIATION 0.7 • n=7 Participants	2.0 units STANDARD_DEVIATION 0.7 • n=5 Participants

PRIMARY outcome

Timeframe: 9 weeks

The BASIS 32 psychometric includes several subscales, including "daily living and role functioning" (DLRF). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension and lower scores denoting better outcomes. Measured weekly for 9 weeks. Reported as mean of 9 weeks.

Outcome measures

Outcome measures
Measure	Fluoxetine (FLX) Plus Eszopiclone (ESZ) n=30 Participants Participants will receive treatment with eszopiclone and fluoxetine	FLX Plus Placebo n=30 Participants Participants will receive treatment with placebo and fluoxetine
Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings	0.81 units on a scale Standard Deviation 0.64	1.2 units on a scale Standard Deviation 0.72

PRIMARY outcome

Timeframe: 9 weeks

The BASIS 32 psychometric includes several subscales, including "relation to self and others" (RSO). These subscales are rated from 0-4, with higher scores indicating a greater deal of difficulty in this dimension. Measured weekly for 9 weeks. Reported as mean of 9 weeks.

Outcome measures

Outcome measures
Measure	Fluoxetine (FLX) Plus Eszopiclone (ESZ) n=30 Participants Participants will receive treatment with eszopiclone and fluoxetine	FLX Plus Placebo n=30 Participants Participants will receive treatment with placebo and fluoxetine
Relation to Self/Others (RSO) Basis-32 Subscale Ratings	0.74 units on a scale Standard Deviation 0.71	1.04 units on a scale Standard Deviation 0.77

PRIMARY outcome

Timeframe: 9 weeks

The Q-LES-Q is scored from 0-100, with higher scores better than lower. Measured weekly for 9 weeks. Reported as mean of 9 weeks.

Outcome measures

Outcome measures
Measure	Fluoxetine (FLX) Plus Eszopiclone (ESZ) n=30 Participants Participants will receive treatment with eszopiclone and fluoxetine	FLX Plus Placebo n=30 Participants Participants will receive treatment with placebo and fluoxetine
Quality of Life Ratings, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)	50.2 units on a scale Standard Deviation 8.11	46.9 units on a scale Standard Deviation 9.0

SECONDARY outcome

Timeframe: 9 weeks

The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score, range 0-28. Lower scores represent better outcomes. Total score categories: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe).

Outcome measures

Outcome measures
Measure	Fluoxetine (FLX) Plus Eszopiclone (ESZ) n=30 Participants Participants will receive treatment with eszopiclone and fluoxetine	FLX Plus Placebo n=30 Participants Participants will receive treatment with placebo and fluoxetine
Insomnia Severity Index (ISI)	21.1 units on a scale Standard Deviation 4	20.2 units on a scale Standard Deviation 4.1

Adverse Events

Fluoxetine (FLX) Plus Eszopiclone (ESZ)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

FLX Plus Placebo

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

Vaughn McCall

August Health University

Phone: 706-721-3141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place