SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

PHASE3TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

February 1, 2013

Primary Completion Date

April 1, 2013

Study Completion Date

April 1, 2013

Conditions
Schizophrenia
Interventions
DRUG

SPD489 low dose range (40mg, 80mg, and 100mg)

"Capsule, dose titration,~* 40 mg capsule once-daily for 1 week; then~* 80 mg capsule once-daily for 4 weeks; then,~* 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~* if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"

DRUG

SPD489 high dose range (120mg, 140mg and 160mg)

"Capsule, dose titration,~* 40 mg capsule once-daily for 1 week; then~* 80 mg capsule once daily for 1 week; then~* 120 mg capsule once-daily for 1 week, then,~* 140 mg capsule once-daily for 2 weeks, then~* 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~* if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"

DRUG

Placebo

One capsule a day for 26 weeks

Trial Locations (4)

19139

CRI Lifetree, Philadelphia

33166

Galiz Research, Miami Springs

63304

St. Charles Psychiatric Associates, Saint Charles

63368

Psychiatric Care and Research Center, O'Fallon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT01760889 - SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia | Biotech Hunter | Biotech Hunter