Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/06/2009
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

Dr Richard Morriss

ORCID ID

Contact details

Department of Community Psychiatry
University of Manchester
Withington Hospital
Manchester
M20 8LR
United Kingdom

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes