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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00449397

Enrollment

150

Registered

2007-03-20

Start date

2003-07-31

Completion date

2006-01-31

Last updated

2011-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis

Keywords

First Episode Psychosis

Brief 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

Interventions

DRUGQuetiapine Fumarate

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

15 Years to 25 Years

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

Design outcomes

Primary

Measure	Time frame
Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale	—

Secondary

Measure	Time frame
SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026