Study to Evaluate the Efficacy and Safety of GSK239512 in Schizophrenia

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: GSK239512; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01009060

113147

Details and patient eligibility

About

This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512 compared to placebo in patients with schizophrenia

Full description

This is a 7-week, Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group design study in male and female subjects with schizophrenia who are stabilised on antipsychotic medication. Subjects will be randomised to receive either GSK239512 or placebo for 7 weeks. They will undergo weekly review of safety, tolerability and cognitive performance measures.

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of Schizophrenia
2. No acute exacerbation of symptoms requiring hospital admission or step up care in the previous six months.
3. Not on any symptomatic treatment for cognition

Exclusion criteria

1. Poses a significant homicidal or suicidal risk or evidence of previous homicidal or suicidal risk.
2. Co-morbid psychiatric or significant physical illness
3. Alcohol or drug abuse or dependence.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups, including a placebo group

GSK239512

Experimental group

Description:

Repeat dose.

Treatment:

Drug: GSK239512

Placebo

Placebo Comparator group

Description:

Repeat dose. Placebo to match GSK239512

Treatment:

Drug: Placebo