Mental and Behavioural Disorders: Bipolar disorders Mental and Behavioural Disorders Bipolar disorders
Conditions
Interventions
Randomised controlled trial, research with outpatients
Sponsors
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 70 bipolar patients from Newcastle and North Tyneside.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
United Kingdom
Outcome results
None listed