drugset / Trial / NCT01234298

SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

NCT01234298 ↗

Phase 3 Withdrawn Shire
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia.

Timeline

Start
2012-01-27
Primary completion
2014-02-24
Completion
2014-02-24

Outcome

Outcome not reported

Stopped (Business): “Study was discontinued due to non-safety related business prioritization decisions”

Drugs

EvaluationDrugModalityDoseRoute
Subject Lisdexamfetamine Dimesylate Small molecule 20 mg —
Subject Lisdexamfetamine Dimesylate Small molecule 30 mg —
Subject Lisdexamfetamine Dimesylate Small molecule 40 mg —
Subject Lisdexamfetamine Dimesylate Small molecule 50 mg —
Subject Lisdexamfetamine Dimesylate Small molecule 60 mg —
Subject Lisdexamfetamine Dimesylate Small molecule 70 mg —

Indications

No indication recorded.