Study to Asses Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of AZD0328 in Patients With Schizophrenia

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: AZD0328

Study type: Interventional

Funder types: Industry

Identifiers

NCT00669903

D0190C00007

Details and patient eligibility

About

This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of multiple ascending doses of AZD0328 in patients with schizophrenia

Enrollment: 100 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of schizophrenia according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)
• Low level of Extra-pyramidal symptoms
• No clinically significant findings on physical examination

Exclusion criteria

• Diagnosis of schizoaffective or schizophreniform disorders
• Any significant psychiatric or neurological disease other than schizophrenia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

AZD0328 low dose

Treatment:

Drug: AZD0328

2

Experimental group

Description:

AZD0328 Optimal dose

Treatment:

Drug: AZD0328

3

Experimental group

Description:

AZD0328 High dose

Treatment:

Drug: AZD0328

4

Placebo Comparator group

Description:

Placebo Comparator

Treatment:

Drug: Placebo