Trial Outcomes & Findings for Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia (NCT NCT00645944)

Last Updated: 2015-07-16

Results Overview

The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that provides a global measure of insomnia severity based on several indicators (e.g., difficulty falling or staying asleep, satisfaction with sleep, degree of impairment with daytime functioning). It has adequate internal consistency (Cronbach's alpha=0.91) and temporal stability (r=0.80), has been validated against sleep diary and polysomnography data and was sensitive to change in several insomnia treatment studies. The ISI scale range is: minimum = 0, maximum = 28. The interpretation is that lower is 'better sleep', while higher is considered 'worse sleep/more insomnia'.

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

8 Weeks

Results posted on

2015-07-16

Participant Flow

The study was conducted between May 2008 and February 2011 at a community mental health center. Following screening and baseline assessment, eligible patients who continued to meet inclusion criteria were randomly assigned to either placebo or eszopiclone in a 1:1 ratio using a randomization procedure blind to both research team and subjects.

179 outpatients were screened, 44 met initial eligibility criteria. Forty-three consented to participate and 4 were withdrawn prior to randomization. Of the remaining 39, 19 were randomized to placebo and 20 to eszopiclone 3mg. Two participants in the placebo arm and 1 participant in the eszopiclone arm withdrew before receiving study medication

Participant milestones

Participant milestones
Measure	Eszopiclone Group Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.	Placebo Group Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study. Placebo: Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study
Randomized STARTED	20	19
Randomized COMPLETED	19	17
Randomized NOT COMPLETED	1	2
Received Medication STARTED	19	17
Received Medication COMPLETED	13	14
Received Medication NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Eszopiclone Group Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.	Placebo Group Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study. Placebo: Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study
Randomized Withdrawal by Subject	1	2
Received Medication Adverse Event	2	1
Received Medication Withdrawal by Subject	1	1
Received Medication Lost to Follow-up	1	0
Received Medication Protocol Violation	2	1

Baseline Characteristics

Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eszopiclone Group n=19 Participants Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.	Placebo Group n=17 Participants Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study. Placebo: Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study	Total n=36 Participants Total of all reporting groups
Age, Continuous	45.7 years STANDARD_DEVIATION 7.4 • n=99 Participants	47.5 years STANDARD_DEVIATION 10.2 • n=107 Participants	46.5 years STANDARD_DEVIATION 12.9 • n=206 Participants
Sex: Female, Male Female	9 Participants n=99 Participants	9 Participants n=107 Participants	18 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	8 Participants n=107 Participants	18 Participants n=206 Participants

PRIMARY outcome

Timeframe: 8 Weeks

Population: Of 39 eligible participants, 19 were randomized to placebo and 20 to eszopiclone 3mg. Two participants in the placebo arm and 1 participant in the eszopiclone arm withdrew before receiving study medication. 36 participants were included in the modified ITT analysis

Outcome measures

Outcome measures
Measure	Eszopiclone Group n=19 Participants Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.	Placebo Group n=17 Participants Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study. Placebo: Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study
Change in Insomnia Severity Index From Baseline.	-10.7 units on a scale Interval -13.2 to -8.2	-6.9 units on a scale Interval -9.5 to -4.3

Adverse Events

Eszopiclone Group

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo Group

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Eszopiclone Group n=19 participants at risk Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.	Placebo Group n=17 participants at risk Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study. Placebo: Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study
General disorders Unpleasant Taste	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
General disorders Fatigue	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Nervous system disorders Memory Problems	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.

Other adverse events

Additional Information

Cenk Tek, M.D.

Yale University

Phone: 203-974-7484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Eszopiclone Group n=19 participants at risk Participants assigned to this arm will receive Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks. Eszopiclone: Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.	Placebo Group n=17 participants at risk Participants assigned to this arm will receive placebo (an inactive substance or a "sugar pill") to be taken each night for all weeks of the study. Placebo: Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study
General disorders Sedation/drowsiness	42.1% 8/19 • Number of events 8 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	41.2% 7/17 • Number of events 7 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
General disorders Fatigue/Weakness	10.5% 2/19 • Number of events 2 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
General disorders Irritability	10.5% 2/19 • Number of events 2 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Nervous system disorders Headache	21.1% 4/19 • Number of events 4 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Psychiatric disorders Excitement/nervousness	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Psychiatric disorders Malaise	15.8% 3/19 • Number of events 3 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Nervous system disorders Memory Problems	0.00% 0/19 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Psychiatric disorders Delusions	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Nervous system disorders Dizziness/faintness	10.5% 2/19 • Number of events 2 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Eye disorders Vision Blurred	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	10.5% 2/19 • Number of events 2 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
General disorders Dry Mouth	26.3% 5/19 • Number of events 5 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	23.5% 4/17 • Number of events 4 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
General disorders Increased Salivation	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
General disorders Unpleasant Taste	36.8% 7/19 • Number of events 7 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Nervous system disorders Tremor	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Nervous system disorders Ataxia	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/19 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Gastrointestinal disorders Nausea/Vomiting	10.5% 2/19 • Number of events 2 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Gastrointestinal disorders Stomach/ abdominal discomfort	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Gastrointestinal disorders Constipation	0.00% 0/19 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Gastrointestinal disorders Diarrhea	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Renal and urinary disorders Urination Problems	0.00% 0/19 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Reproductive system and breast disorders Libido Decrease	0.00% 0/19 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Reproductive system and breast disorders Orgasmic Dysfunction	0.00% 0/19 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	5.9% 1/17 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Skin and subcutaneous tissue disorders Sweating	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Metabolism and nutrition disorders Appetite Decrease	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Metabolism and nutrition disorders Appetite Increase	10.5% 2/19 • Number of events 2 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
Metabolism and nutrition disorders Weight Loss	10.5% 2/19 • Number of events 2 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	0.00% 0/17 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.
General disorders Other	5.3% 1/19 • Number of events 1 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.	17.6% 3/17 • Number of events 3 • 8 Weeks Adverse events reported in either placebo or eszopiclone group during double blind phase at 8 weeks.