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Sodium Oxybate in Schizophrenia With Insomnia

This study has been completed.
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Daniel C. Javitt, MD, PhD, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT00594256
First received: January 3, 2008
Last updated: January 5, 2016
Last verified: January 2016
Results First Received: June 6, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia
Insomnia Related to Schizophrenia (307.42)
Intervention: Drug: Sodium Oxybate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Rockland Psychiatric Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)

Participant Flow:   Overall Study
    Sodium Oxybate (Open Label)  
STARTED     8  
COMPLETED     8  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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)

Baseline Measures
    Sodium Oxybate (Open Label)  
Number of Participants  
[units: participants]
  8  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  41.8  (10)  
Gender  
[units: participants]
 
Female     1  
Male     7  
Region of Enrollment  
[units: participants]
 
United States     8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pittsburgh Sleep Quality Index   [ Time Frame: 1 month ]

2.  Primary:   Epworth Sleepiness Scale   [ Time Frame: 1 month ]

3.  Secondary:   Positive and Negative Syndrome Scale (PANSS) Negative Factor   [ Time Frame: 1 month ]

4.  Secondary:   MATRICS Neurocognitive Battery Composite   [ Time Frame: 1 month ]

5.  Secondary:   Slow Wave Sleep Minutes   [ Time Frame: 1 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Open Label Small sample


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joshua Kantrowitz MD
Organization: Nathan Kline Institute
phone: 845-398-5503
e-mail: jkantrowitz@nki.rfmh.org


Publications of Results:

Responsible Party: Daniel C. Javitt, MD, PhD, Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier: NCT00594256     History of Changes
Other Study ID Numbers: 07I/C36-0
Study First Received: January 3, 2008
Results First Received: June 6, 2011
Last Updated: January 5, 2016
Health Authority: United States: Institutional Review Board