Please note that the ANZCTR website will be unavailable from 9am until 9.30am (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis
Scientific 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.
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosis 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Psychosis and personality disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Quetiapine Fumarate

Treatment: Drugs: Quetiapine Fumarate

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale
Timepoint [1] 0 0
Secondary outcome [1] 0 0
SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates
Timepoint [1] 0 0

Key inclusion criteria
- Patients experiencing their first psychotic episode

- Male or Female

- Aged 15-25
Minimum age
15 Years
Maximum age
25 Years
Both males and females
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Sites - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry

Ethics approval
Ethics application status

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
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Gregor Berger, MD
Address 0 0
ORYGEN Research Centre/ ORYGEN Youth Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications