Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Psychosis

Treatments: Drug: Quetiapine Fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00449397

AU-SEA-0003

Details and patient eligibility

About

The purpose of this study is determine the minimal effective dose and the impact on:

1. treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode
2. the final maintenance doses
3. the use of other medications
4. the amount of changes to other antipsychotic medication
5. the number of hospitalization days

Sex: All

Ages: 15 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients experiencing their first psychotic episode
• Male or Female
• Aged 15-25

Exclusion criteria

• Previous treatment with antipsychotic medication (longer than 1 week)
• History of a clinically significant physical illness
• Organic disorder presenting with psychotic symptoms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind