Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms

Shire

Status and phase: Completed; Phase 2

Conditions: Schizophrenia and Predominant Negative Symptoms

Treatments: Drug: SPD489 (lisdexamfetamine dimesylate); Drug: Placebo matching SPD489 (lisdexamfetamine dimesylate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00922272

SPD489-204

Details and patient eligibility

About

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).

Enrollment: 92 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18-55
• Clinically stable Schizophrenia and predominant negative symptoms
• Taking a stable dose of antipsychotic medication

Exclusion criteria

• Clinically notable positive symptoms defined by PANSS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups, including a placebo group

SPD489 (Lisdexamfetamine dimesylate)

Experimental group

Treatment:

Drug: SPD489 (lisdexamfetamine dimesylate)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo matching SPD489 (lisdexamfetamine dimesylate)