Bipolar at risk trial

Not Applicable

Completed

• Conditions: Topic: Mental Health; Subtopic: Bipolar affective disorder; Mental and Behavioural Disorders; Disease: Bipolar affective disorder

• Registration Number: ISRCTN10773067
• Lead Sponsor: Greater Manchester West Mental Health NHS Foundation Trust

Brief Summary

2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33063921/ qualitative investigation of participant experiences (added 29/10/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-26
• Study Completion: 2016-12-01
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Age 16-25 years old
2. Meet criteria for one of the following Bipolar At Risk (BAR) criteria:
2.1. Group I: Subthreshold mania (Young Mania Rating Scale total score between 5 and 15 + elevated mood = 2 + irritability = 2 for at least 4 days)
2.2. Group II: Depression + Cyclothymia: mild depressive symptoms (BDI-II >20 for at least 1 week) + diagnosis of cyclothymic disorder or bipolar disorder NOS as assessed by SCID I
2.3. Group III: Depression + genetic risk: mild depressive symptoms (BDI-II >20 for at least 1 week) + genetic risk (first degree relative with bipolar disorder)
3. Help seeking
4. Competent and willing to provide written, informed consent

Exclusion Criteria

1. Past history of a treated or untreated manic episode or psychosis of one week duration or longer
2. Past treatment with a mood stabiliser for longer than 6 weeks or antipsychotic for 3 weeks (equals 15 mg per week of haloperidol or equivalent)
3. Moderate to severe learning disability
4. Organic brain disorder
5. Non-english speaking (this would prevent the use of standardised assessment instruments) .
6. Inpatient/acute psychiatric care needed
7. Substance dependency

Study & Design

• Study Type: Interventional
• Study Design: Not specified