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Sodium Oxybate in Schizophrenia With Insomnia

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ClinicalTrials.gov Identifier: NCT00594256
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : February 8, 2016
Last Update Posted : February 8, 2016
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Daniel C. Javitt, MD, PhD, Nathan Kline Institute for Psychiatric Research

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Schizophrenia
Insomnia Related to Schizophrenia (307.42)
Intervention Drug: Sodium Oxybate
Enrollment 8
Recruitment Details Rockland Psychiatric Center
Pre-assignment Details  
Arm/Group Title Sodium Oxybate (Open Label)
Hide Arm/Group Description 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)
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Sodium Oxybate (Open Label)
Hide Arm/Group Description 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 Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
41.8  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
1
  12.5%
Male
7
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Pittsburgh Sleep Quality Index
Hide Description 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.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Sodium Oxybate
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: global score
6.1  (3.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Oxybate
Comments Open label baseline final paired t test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Epworth Sleepiness Scale
Hide Description 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.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Oxybate
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: global score
4.8  (4.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Oxybate
Comments Open label baseline final paired t test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Positive and Negative Syndrome Scale (PANSS) Negative Factor
Hide Description 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
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Paired t test of baseline and final values
Arm/Group Title Sodiumn Oxybate
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mean decrease in negative subscale
2.8  (3.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodiumn Oxybate
Comments Open label baseline final paired t test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title MATRICS Neurocognitive Battery Composite
Hide Description 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).
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sodium Oxybate
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Composite T-score
-.26  (3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Oxybate
Comments Open label baseline final paired t test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Slow Wave Sleep Minutes
Hide Description 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.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
4 pre post
Arm/Group Title Sodium Oxybate
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: minutes
34.1  (26.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Oxybate
Comments Open label baseline final paired t test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sodium Oxybate (Open Label)
Hide Arm/Group Description 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)
All-Cause Mortality
Sodium Oxybate (Open Label)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Sodium Oxybate (Open Label)
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sodium Oxybate (Open Label)
Affected / at Risk (%) # Events
Total   5/8 (62.50%)    
Gastrointestinal disorders   
nausea   2/8 (25.00%)  2
Psychiatric disorders   
agitation   1/8 (12.50%)  1
Renal and urinary disorders   
nocturnal enuresis  2/8 (25.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joshua Kantrowitz MD
Organization: Nathan Kline Institute
Phone: 845-398-5503
EMail: jkantrowitz@nki.rfmh.org
Layout table for additonal information
Responsible Party: Daniel C. Javitt, MD, PhD, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier: NCT00594256    
Other Study ID Numbers: 07I/C36-0
First Submitted: January 3, 2008
First Posted: January 15, 2008
Results First Submitted: June 6, 2011
Results First Posted: February 8, 2016
Last Update Posted: February 8, 2016