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
Orygen Youth Health Research Centre
163 participants
May 30, 2010
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
Plain Language Summary
Simplified for easier understanding
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 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)
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ACTRN12610000244000