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

NCT ID: NCT00449397

Last Updated: 2011-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quetiapine Fumarate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gregor Berger, MD

Role: PRINCIPAL_INVESTIGATOR

ORYGEN Research Centre/ ORYGEN Youth Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Sites

Melbourne, , Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

References

Explore related publications, articles, or registry entries linked to this study.

Hides L, Cotton SM, Berger G, Gleeson J, O'Donnell C, Proffitt T, McGorry PD, Lubman DI. The reliability and validity of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in first-episode psychosis. Addict Behav. 2009 Oct;34(10):821-5. doi: 10.1016/j.addbeh.2009.03.001. Epub 2009 Mar 6.

Reference Type DERIVED
PMID: 19324499 (View on PubMed)

Berger GE, Proffitt TM, McConchie M, Kerr M, Markulev C, Yuen HP, O'Donnell C, Lubman D, Polari A, Wood S, Amminger PG, McGorry PD. Dosing quetiapine in drug-naive first-episode psychosis: a controlled, double-blind, randomized, single-center study investigating efficacy, tolerability, and safety of 200 mg/day vs. 400 mg/day of quetiapine fumarate in 141 patients aged 15 to 25 years. J Clin Psychiatry. 2008 Nov;69(11):1702-14. Epub 2008 Nov 18.

Reference Type DERIVED
PMID: 19036233 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AU-SEA-0003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Antipsychotic Therapy and First Episode
NCT00334035 COMPLETED PHASE4
Treatment of Depression With Quetiapine
NCT00174603 TERMINATED PHASE3
Seroquel XR in Adults With Schizophrenia
NCT00852631 TERMINATED PHASE3