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ISRCTN
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ISRCTN21277091
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtain treatment
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To determine the efficacy of teaching patients with bipolar disorder (manic-depressive psychosis) to identify early symptoms of relapse and seek prompt treatment from health services.
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Ethics approval
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The study was approved by a medical ethics committee in each NHS trust. Each patient gave written informed consent to the trial.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Schizophrenia and other psychoses
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Participants - inclusion criteria
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1. A lifetime diagnosis of bipolar disorder elicited by a trained research assistant using a standardised psychiatric interview
2. Two or more relapses
3. One in the previous 12 months
4. Aged 18 to 75 years
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Participants - exclusion criteria
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1. An inability to read or write in English
2. Drug or alcohol misuse or dependence as a primary problem
3. An organic cerebral cause for bipolar disorder, e.g., multiple sclerosis or stroke
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Anticipated start date
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01/03/1994
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Anticipated end date
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01/04/1997
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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69
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Interventions
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7 - 12 intervention treatment sessions from a research psychologist plus routine care versus routine care only.
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Primary outcome measure(s)
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1. Time to first manic or depressive relapse
2. Number of manic or depressive relapses
3. Social functioning examined by standardised interviews every six months for 18 months
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive North West (UK)
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Trial website
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Publications
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1999 results on http://www.ncbi.nlm.nih.gov/pubmed/9888904
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Contact name
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Dr
Richard
Morriss
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Address
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Department of Community Psychiatry
University of Manchester
Withington Hospital
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City/town
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Manchester
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Zip/Postcode
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M20 8LR
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Country
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United Kingdom
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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01/06/2009
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Date ISRCTN assigned
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23/01/2004
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