Phase 2
Completed N=8
Sodium Oxybate in Schizophrenia With Insomnia
Schizophrenia · Insomnia Related to Schizophrenia (307.42)
Source: ClinicalTrials.gov NCT00594256 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Pittsburgh Sleep Quality Index — 6.1 global score — p==0.002
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pittsburgh Sleep Quality Index |
6.1 | =0.002 sig |
| PRIMARY Epworth Sleepiness Scale |
4.8 | 0.02 sig |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) Negative Factor |
2.8 | 0.04 sig |
| SECONDARY MATRICS Neurocognitive Battery Composite |
-.26 | 0.8 |
| SECONDARY Slow Wave Sleep Minutes |
34.1 | <0.01 sig |
Eligibility Criteria
Inclusion Criteria
- Patients aged 18-45 with a DSM-IV diagnosis of schizophrenia and insomnia related to schizophrenia, confirmed by a structured interview (SCID).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00594256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.