Intensify - Bipolar Disorder
Research type
Research Study
Full title
INTENSIFY BD: A randomised, controlled trial to investigate the effect of a six-week intensified pharmacological treatment for bipolar depression compared to treatment as usual in subjects who had a first-time treatment failure on their first-line treatment.
IRAS ID
1009116
Contact name
Inge Winter
Contact email
Sponsor organisation
University Medical Center Utrecht
Clinicaltrials.gov Identifier
Research summary
When people with a bipolar disorder are diagnosed, treatment is initiated and usually a medication is started. Beforehand it is unknown if the medication will reduce symptoms or what side effects the medication will cause. When the first-line treatment does not work sufficiently, it is currently unknown what medication works best as a second-line treatment. We think that if the first treatment does not work sufficiently, it may be better to use a combination of medications (generally used as a third-line treatment), instead of the usual second-line treatment. Third-line treatments are expected to be more effective. In this study, participants with bipolar disorder who felt their first treatment was in effective will be recruited. They will be randomised 1:1 to either treatment as usual (normal second line treatment) or early intensified treatment (one anti-depressant plus two mood stabilisers). All treatments used in this study are already widely available and frequently used in daily clinical practice, with known safety profiles. There are no new or experimental treatments. Instead, the study is testing the earlier use of a combination of medications. The study will last about 3 months, with a treatment duration of 6-weeks. As the medications are already widely used, participants may be able to stay on their medication if they wish.
REC name
East of England - Essex Research Ethics Committee
REC reference
24/EE/0067
Date of REC Opinion
14 Oct 2024
REC opinion
Further Information Favourable Opinion