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

NCT01760889 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-06-22

Study results available
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Summary

The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.

Conditions

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

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-01
Primary Completion
2013-04-01
Completion
2013-04-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01760889 on ClinicalTrials.gov