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Clinical Trials/NCT00449397
NCT00449397
Completed
Phase 3

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.

AstraZeneca1 site in 1 country150 target enrollmentJuly 2003
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ConditionsPsychosis
DrugsQuetiapine Fumarate

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Psychosis
Sponsor
AstraZeneca
Enrollment
150
Locations
1
Primary Endpoint
Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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
Registry
clinicaltrials.gov
Start Date
July 2003
End Date
January 2006
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Study Sites (1)

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