Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
The study was approved by a medical ethics committee in each NHS trust. Each patient gave written informed consent to the trial.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Schizophrenia and other psychoses
Intervention
7 - 12 intervention treatment sessions from a research psychologist plus routine care versus routine care only.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/1994
Overall trial end date
01/04/1997
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
69
Participant exclusion criteria
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
Recruitment start date
01/03/1994
Recruitment end date
01/04/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Community Psychiatry
Manchester
M20 8LR
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive North West (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1999 results on http://www.ncbi.nlm.nih.gov/pubmed/9888904
Publication citations
-
Results
Perry A, Tarrier N, Morriss R, McCarthy E, Limb K, Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtain treatment., BMJ, 1999, 318, 7177, 149-153.