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OpenTrials
Completed

NCT Number: NCT00449397

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

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

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Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Sites

Melbourne, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine fumarate

Drug

Primary outcomes

  1. Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale

Secondary outcomes

  1. SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Mar 20, 2007
Registry last updated
Jan 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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