Trial Outcomes & Findings for Sodium Oxybate in Schizophrenia With Insomnia (NCT NCT00594256)

Results Overview

This rating scale generates a global sleep-quality score, as well as scores on 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The 19 items are combined to form seven "component" scores, each of which has a range of O-3 points. The seven component scores are then added to yield one "global" score, with a range of O-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

1 month

Results posted on

2016-02-08

Participant Flow

Rockland Psychiatric Center

Participant milestones

Participant milestones
Measure	Sodium Oxybate (Open Label) open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sodium Oxybate in Schizophrenia With Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sodium Oxybate (Open Label) n=8 Participants open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.8 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: ITT

This rating scale generates a global sleep-quality score, as well as scores on 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The 19 items are combined to form seven "component" scores, each of which has a range of O-3 points. The seven component scores are then added to yield one "global" score, with a range of O-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.

Outcome measures

Outcome measures
Measure	Sodium Oxybate n=8 Participants
Pittsburgh Sleep Quality Index	6.1 global score Standard Deviation 3.7

PRIMARY outcome

Timeframe: 1 month

Designed to measure daytime sleepiness. 8 items rated 0-3, with higher scores associated with a greater daytime sleepiness. overall score rated 0-24, with scores greater than 10 indicating significant daytime sleepiness.

Outcome measures

Outcome measures
Measure	Sodium Oxybate n=8 Participants
Epworth Sleepiness Scale	4.8 global score Standard Deviation 4.6

SECONDARY outcome

Timeframe: 1 month

Population: Paired t test of baseline and final values

The PANSS Negative factor is a 7-item rating scale widely used in the assessment of schizophrenia. Range is 7-49 with higher scores worse

Outcome measures

Outcome measures
Measure	Sodium Oxybate n=8 Participants
Positive and Negative Syndrome Scale (PANSS) Negative Factor	2.8 mean decrease in negative subscale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 1 month

This is a series of neurocognitive tests developed by the National Institute of Mental Health to evaluate medications targeting cognition in an efficient and reliable manner. It will be modified by the deletion of the social competence domain. The six domains include speed of processing, attention/vigilance, working memory, verbal learning, visual learning and reasoning/problem solving. The primary outcome will be the mean T-score (mean of six domains).

Outcome measures

Outcome measures
Measure	Sodium Oxybate n=8 Participants
MATRICS Neurocognitive Battery Composite	-.26 Composite T-score Standard Deviation 3.8

SECONDARY outcome

Timeframe: 1 month

Population: 4 pre post

Overnight sleep study: Subjects will undergo polysomnography four times during this study, on consecutive nights during the observation week and on consecutive nights at the end. Polysomnography will be performed in a modified seclusion room on the in patient unit. The first of the consecutive nights will be used for adaptation to the study conditions. Sleep was recorded between lights off (10 pm) and lights on (at 6:45 am). We aim for conditions for falling asleep as comfortable as possible under the experimental condition.

Outcome measures

Outcome measures
Measure	Sodium Oxybate n=4 Participants
Slow Wave Sleep Minutes	34.1 minutes Standard Deviation 26.0

Adverse Events

Sodium Oxybate (Open Label)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sodium Oxybate (Open Label) n=8 participants at risk open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
Gastrointestinal disorders nausea	25.0% 2/8 • Number of events 2
Renal and urinary disorders nocturnal enuresis	25.0% 2/8 • Number of events 2
Psychiatric disorders agitation	12.5% 1/8 • Number of events 1

Additional Information

Joshua Kantrowitz MD

Nathan Kline Institute

Phone: 845-398-5503

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place