Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia

Shire

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: SPD489 (Lisdexamfetamine dimesylate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01457339

SPD489-119

Details and patient eligibility

About

This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Subjects must be diagnosed with schizophrenia, on a stable dose of an antipsychotic and not have any cardiac risk factors

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

31 participants in 2 patient groups, including a placebo group

SPD489 (Lisdexamfetamine dimesylate)

Experimental group

Treatment:

Drug: SPD489 (Lisdexamfetamine dimesylate)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo