Sodium Oxybate in Schizophrenia With Insomnia

NCT00594256 | Completed Phase 2 Results

• 1 other identifier: 07I/C36-0
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The present protocol proposes study of the recently approved compound sodium oxybate (Xyrem), a gamma-aminobutyric acid type b (GABAB) and a g-hydroxybutyric acid (GHB) receptor agonist, for the study of persistent symptoms of schizophrenia. Sodium oxybate is a central nervous system depressant currently approved for treatment of narcolepsy associated with cataplexy and excessive daytime sleepiness. In addition to evaluating effects on sodium oxybate on persistent symptoms and neurocognitive deficits in schizophrenia, the study will test the hypothesis that this medication may be particularly effective in combating Insomnia Related to Schizophrenia, and in normalizing symptomatic and polysomnographic manifestations of sleep-related brain dysfunction in schizophrenia.

Conditions

Schizophrenia; Insomnia Related to Schizophrenia (307.42)

Keywords

Schizophrenia; Sleep Architecture; Sodium Oxybate; Insomnia; Cognition

Outcome Measures

Primary Outcomes (2)

• Pittsburgh Sleep Quality Index

  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.

  1 month

• Epworth Sleepiness Scale

  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.

  1 month

Secondary Outcomes (3)

• Positive and Negative Syndrome Scale (PANSS) Negative Factor

  1 month

• MATRICS Neurocognitive Battery Composite

  1 month

• Slow Wave Sleep Minutes

  1 month

Study Arms (1)

Sodium oxybate

EXPERIMENTAL

Active treatment

Drug: Sodium Oxybate

Interventions

Sodium Oxybate DRUG

Patients will undergo a one-week evaluation period, which will include a taper and discontinuation of any currently prescribed sedative/hypnotics, as well as baseline diagnostic, psychopathology, neurocognitive and polysomnographic measurements (see below for details). Hypnotic taper may be extended or abbreviated, depending on clinical judgment. Patients will then begin a 4-week trial of adjunctive Xyrem (sodium oxybate). Patients will begin at 4.5 g/night (in divided doses of 2.25 g, with 1st dose at bedtime and then 2nd dose four hours later). Dosage will increase by 1.5 g/day every week, until a dose of 9 g nightly is reached, or a patient cannot tolerate further dose escalations. Medication will be administered in divided dosage for the duration of the study. A three-week taper (by 3 g/day weekly) of sodium oxybate will follow the four-week trial of sodium oxybate.

Also known as: Xyrem

Sodium oxybate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-45 with a DSM-IV diagnosis of schizophrenia and insomnia related to schizophrenia, confirmed by a structured interview (SCID).

You may not qualify if:

• Lack of capacity to give informed consent (capacity is determined by a licensed member of the treatment team).
• Unstable medical illness.
• Diagnosis of restless leg syndrome, a seizure disorder, uncontrolled hypertension, unstable cardiac illness, or obstructive sleep apnea.
• Pregnancy or lack of adequate birth control.
• History of substance dependence disorder.
• Current treatment with valproic acid.
• Succinic semialdehyde dehydrogenase deficiency (SSADH).
• Persistent need for treatment with benzodiazepines, barbiturates, opiates or other sedative hypnotics.

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

Nathan Kline Insitute for Psychiatric Research

Orangeburg, New York, 10962, United States

Location

Related Publications (1)

• Kantrowitz JT, Oakman E, Bickel S, Citrome L, Spielman A, Silipo G, Battaglia J, Javitt DC. The importance of a good night's sleep: an open-label trial of the sodium salt of gamma-hydroxybutyric acid in insomnia associated with schizophrenia. Schizophr Res. 2010 Jul;120(1-3):225-6. doi: 10.1016/j.schres.2010.03.035. No abstract available.

  PMID: 20435443 RESULT

MeSH Terms

Conditions

Schizophrenia; Sleep Initiation and Maintenance Disorders

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Limitations and Caveats

Open Label Small sample

Results Point of Contact

• Title: Joshua Kantrowitz MD
• Organization: Nathan Kline Institute

jkantrowitz@nki.rfmh.org

845-398-5503

Study Officials

• Daniel C Javitt, MD PhD

  Nathan Kline Institute for Psychiatric Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Schizophrenia Research Center

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 15, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 8, 2016
• Results First Posted: February 8, 2016

Record last verified: 2016-01

Locations

US (1)