TerminatedPhase 4ACTRN12610000244000

A comparison study of quetiapine medication and psychological therapy versus placebo tablets and psychological therapy in patients who are deemed at risk of developing a psychotic disorder.

The NEURAPRO-Q (North America, EURope, Australia PROdrome) Study: A multicentre randomised controlled trial (RCT) to evaluate the effect of Quetiapine and Cognitive-Behavioural Case Management on the incidence of first episode psychosis in Symptomatic Patients at Ultra-High Risk for Early Progression to Schizophrenia and Other Psychotic Disorders


Sponsor

Orygen Youth Health Research Centre

Enrollment

163 participants

Start Date

May 30, 2010

Study Type

Interventional

Conditions

Summary

This study was terminated in July 2011 due to feasibility reasons. Although ethics approval had been obtained, recruitment of participants never commenced.


Eligibility

Sex: Both males and femalesMin Age: 15 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether combining the medication quetiapine with psychological therapy can help young people aged 15 to 40 who are at high risk of developing a psychotic disorder. The goal is to see if early treatment can prevent or delay the onset of full psychosis.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

To investigate the effect of quetiapine, in addition to CBCM (cognitive behavioural case management) on the incidence of first episode psychosis. The quetiapine dose will be flexible at the discretion

To investigate the effect of quetiapine, in addition to CBCM (cognitive behavioural case management) on the incidence of first episode psychosis. The quetiapine dose will be flexible at the discretion of the treating clinician (within the 50-400mg range). Patients will commence on a dose of 50mg per day. This will gradually be titrated upwards in increments of 50mg per week with 400mg as the maximum dose. Note that 400mg is the mximum dose and therefore not necessarily the ideal dose for each patient. Duration of treatment will be over a 6 month period. The mode of administration will be oral capsules. Cognitive Behavioural Case Management (CBCM) is a psychological treatment that incorporates Cognitive Behaviour Therapy (CBT) into case management, and will be provided by the clinician on a one-on-one (approximately one hour) weekly session for 6 months, and then on an "as needs" basis for up to 12 months from entry. A standardised manual has been developed by Orygen to ensure consistency across all sites.


Locations(2)

Minneapolis, United States of America

Hong Kong, Hong Kong

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ACTRN12610000244000