Condition category
Mental and Behavioural Disorders
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
08/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof AH Young

ORCID ID

Contact details

Academic Psychiatry
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes