Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0573157682
Study information
Scientific title
Acronym
Study hypothesis
Does group psychoeducation reduce time to manic relapse, number of manic relapses, and improve social functioning in patients with bipolar affective disorder?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Mental and Behavioural Disorders: Bipolar disorders
Intervention
Randomised controlled trial, research with outpatients
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Time to manic relapse and number of manic relapses in each 6 month period. Relapse will be defined as SCID criteria for hypomania or mania. Raters (who will be blind to the randomisation) will keep in close contact with patients, keyworkers and RMOs to ensure that relapses are spotted.
2. Social functioning determined by standardised ratings at 0, 6, 12, and 18 months after randomisation.
3. MADRS and Young scores will be determined at 0, 6, 12 and 18 months after randomisation.
Secondary outcome measures
In order to provide clarification of how patients have progressed throughout the course of the study patients in both conditions will be keeping a mood diary on a daily basis. The mood diary lists a variety of symptoms associated with bipolar disorder. Each day patients will rate the severity of each of the symptoms on a 4 point scale (0=none, 4=severe).
Overall trial start date
01/12/2003
Overall trial end date
30/11/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
70 bipolar patients from Newcastle and North Tyneside.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
70
Participant exclusion criteria
1. Patient with learning disability, axis 1 co-morbidity, alcohol or drug dependency
2. Serious suicidal intent
3. Personality disorder
4. Organic brain disorder
5. Patients undergoing any concurrent psychological therapy
6. Bipolar disorder with a seasonal pattern
Recruitment start date
01/12/2003
Recruitment end date
30/11/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Psychiatry
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
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
Newcastle, North Tyneside and Northumberland Mental Health NHS Trust (UK), NHS R&D Support Funding
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
Basic results (scientific)
Publication list