The COMBINER Trial
Project overview
Currently there are a lack of treatment options for people with bipolar who experience feeling elated (hypomania, mania or psychosis).
The COMBINER trial (The effectiveness of lithium plus quetiapine COMBination versus lithium versus quetiapiNe monothErapy in the maintenance treatment of bipolar disordeR) is looking at two types of medication, lithium and quetiapine. They are used as “maintenance treatment” which means patients take them in the longer term to reduce the risk of having major episodes of depression or feeling elated.
We are investigating whether these drugs, taken together compared with on their own, are better at reducing the chances that a person will experience these episodes in the longer term. We know that both medications work, but we don’t know which is better, or if combining the two could be best.
It will take place over two years in up to twelve different mental health NHS trusts across England.
Participants will be randomly selected to receive lithium, quetiapine, or a combination of lithium and quetiapine. Some participants will have the opportunity to be interviewed about their experiences of taking part in the study.
The sponsor is the University of Birmingham and the study is led by Birmingham Clinical Trials Unit (BCTU). It is funded by the National Institute for Health Research (NIHR).
For further information visit the COMBINER study website.
Project details
In the UK bipolar disorder affects around 1.5-2% of the population, which equates to over 1 million people, or roughly 1 in 50.
For this mood disorder there is very little known about the effect of certain treatments for hypomania, mania and psychosis. This study aims to understand which maintenance treatment for bipolar disorder is better: lithium and quetiapine together, lithium alone, or quetiapine alone.
Maintenance treatment is critical for reducing the number of mood episodes experienced over a person’s lifetime. Patients say that finding the right maintenance treatment early on can stop years of suffering.
Lithium is recommended as the first line maintenance treatment, but antipsychotics are often prescribed instead of, or in addition to, lithium. Combination treatment could be more effective, but tolerability is more of an issue.
Currently there is a lack of good quality evidence to help clinicians and patients make choices about whether lithium, an antipsychotic, or a combination of both is best in maintenance treatment.
People with lived experience of bipolar and carers are involved in the Trial Management Group (TMG) in association with Birmingham Clinical Trials Unit.
McPin has employed a peer researcher with lived experience of being an informal carer for a relative with bipolar. They have an honorary contract with the University of Birmingham.
The Chief Investigator is Professor Steven Marwaha, an academic psychiatrist at Birmingham and Solihull Mental Health NHS Foundation Trust who specialises in mood disorders.
The involvement in the study will also be supported by the charity Bipolar UK.
Please get in touch with [email protected] for more information on this project.
You can also visit the COMBINER study website.
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