Sodium Oxybate in Schizophrenia With Insomnia
Condition: Schizophrenia; Insomnia Related to Schizophrenia (307.42)
MeSH terms: Sleep Initiation and Maintenance Disorders; Schizophrenia
Intervention: Sodium Oxybate
Intervention description: 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.
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Schizophrenia; Sleep Architecture; Sodium Oxybate; Insomnia; Cognition

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.
    

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.