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

Psychosis Clinical Trial

Official title:

A Naturalistic, Prospective, Single Centre, Double Blinded, Fixed Dose, Randomised, Four Week Comparison Study Investigating Efficacy, Tolerability and Safety of 200 mg Per Day Versus 400 mg Per Day Quetiapine Fumarate in 200 Drug naïve First Episode Psychosis Patients Aged 15 to 25 Years.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449397
• Other study ID #: AU-SEA-0003
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2007
• Last updated: January 25, 2011
• Start date: July 2003
• Est. completion date: January 2006

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Drug:
• Quetiapine Fumarate

Locations

Country	Name	City	State
Australia	Research Sites	Melbourne

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale
Secondary	SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates