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Awarded Trial: 03-STN-001

Grant ID

03-STN-001

Illness

Schizophrenia

Primary Drug/Intervention

CX516

Primary Dosage

900 mg t.i.d.

Secondary Drug Intervention

N/A

Secondary Dosage

N/A

Other Drug/Intervention

N/A

Other Dosage

N/A

Status

Completed

Investigator

Goff

Sample Size

105

Duration of Study Period for Each Subject

4 weeks

Outcome Measurements

PANSS, Cognitive Battery, Calgary Depression Scale, Quality of Life Scale

Results

105 patients were randomized and 95 completed the four-week trial. CX516 was associated with a small (effect size 0.32) improvement in the composite cognitive score compared to placebo, which was not statistically significant. Performance was not significantly improved on any cognitive test, nor were any symptom ratings improved with CX516. The PANSS total score was significantly reduced in the placebo group compared to CX516. CX516 was well-tolerated, although associated with a significantly greater incidence of insomnia, fatigue and gastrointestinal complaints.

Publication

N/A

Link

N/A

PI Name

Donald Goff

Degree

MD

Center

Freedom Trail Clinic, Department of Psychiatry

Institution

Massachusetts General Hospital

Address

Lindemann Mental Health Center, 25 Staniford Street

City or Town

Boston

State or Province

MA

Zip or Postal Code

2114

Country

USA

Email Address

goff@psych.mgh.harvard.edu