Sodium Oxybate in Schizophrenia With Insomnia

PHASE2CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
SchizophreniaInsomnia Related to Schizophrenia (307.42)
Interventions
DRUG

Sodium Oxybate

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.

Trial Locations (1)

10962

Nathan Kline Insitute for Psychiatric Research, Orangeburg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

lead

Nathan Kline Institute for Psychiatric Research

OTHER