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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN65818527 |
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Date of registration:
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23/10/2000 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Of Cognitive ReAlignment Therapy in Early Schizophrenia
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Scientific title:
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Date of first enrolment:
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01/04/1996 |
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Target sample size:
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236 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN65818527 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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SW
Lewis |
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Address:
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School of Psychiatry and Behavioural Science
University of Manchester
Withington Hospital
West Didsbury
M20 8LR
Manchester
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Consecutive sample of in- or day-patients admitted with 1st and 2nd episode schizophrenia aged 18-65. Further inclusion criteria:
1. Able to give informed consent
2. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition (DSMIV) diagnostic criteria for schizophrenia, schizophreniform or schizoaffective disorder with at least a 1 month history of positive symptoms
3. No significant history of organic brain disease or substance misuses for major aetiological factor for psychosis
4. Positive and negative syndrome scale (PANSS) for schizophrenia score of at least 4 on item hallucinatory behaviour and/or item delusions
5. Score of less than 5 on PANSS item conceptual disorganisation
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Neurosciences, psychiatry
Mental and Behavioural Disorders
Schizophrenia
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Intervention(s)
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Cognitive behaviour therapy/drug treatments
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Primary Outcome(s)
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1. Change on core symptom scores on hallucination and delusion rating scales
2. Change in total symptoms scores on PANSS
3. Time to criterion of 50% recovery operationally defined -
4. Number of days in hospital before 1st discharge and during follow-up
5. Time to relapse
6. Follow-up symptom and outcome scores at 3.9 and 18 months
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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Medical Research Council (MRC) (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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