At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 92 enrolled
Drug / intervention
SPD489 (lisdexamfetamine dimesylate) +1 moredrug
Likely dose
SPD489 (lisdexamfetamine dimesylate) 70 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter Study With Open-label & Randomized Double-blind Placebo-controlled Withdrawal Phases to Evaluate the Efficacy, Safety, & Tolerability of SPD489 in Adults With Schizophrenia & Predominant Negative Symptoms Who Are Clinically Stable & Taking Stable Doses of Atypical Antipsychotic Medication
In Brief
A Phase 2 clinical trial evaluating SPD489 (lisdexamfetamine dimesylate) and Placebo matching SPD489 (lisdexamfetamine dimesylate) for Schizophrenia and Predominant Negative Symptoms. Completed, enrolled 92 participants across 27 sites.
Detailed Summary
To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartSep 2009
Primary CompletionJan 2011
TodayJul 2026
First PostedJun 17, 2009
Enrollment StartSep 14, 2009
Primary CompletionJan 20, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.0 years ago
Interventions
SPD489 (lisdexamfetamine dimesylate)drug
oral, 20, 30, 40, 50, 60, or 70 mg once daily
Placebo matching SPD489 (lisdexamfetamine dimesylate)drug
oral, once daily