Seroquel XR in Adults With Schizophrenia

AstraZeneca

Status and phase: Terminated; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Quetiapine fumarate (Seroquel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00852631

D1443L00060

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia patients with acute worsening symptoms. Consequently, to assess whether the study drug is safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42 days.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient meets the DSM-IV criteria for schizophrenia
• Patient has a PANSS total score ≥ 70 at baseline
• Patient has a CGI-S score of ≥ 4(moderately ill) at baseline
• Patient is healthy on the basis of physical examination and vital signs at baseline

Exclusion criteria

• Positive urine drug screen for Opiates, amphetamine, barbiturate, cocaine, cannabis, or ecstasy abuse
• Has history of neuroleptic malignant syndrome, seropositive for anti-HIV, hepatitis B or C virus antigen
• Patient with unstable or inadequately treated Diabetes Mellitus
• Use of potent cytochrome P450 inhibitors or inducer within 14 days before baseline

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)