What the trial was testing
The RESTORE enrolled 112 patients with bipolar disorder. The study was sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
52% of men responded when they restarted enzalutamide after testosterone cycling.
The Lancet. Oncology · 2018 · NCT02090114
These findings — that responded when they restarted enzalutamide after testosterone cycling — were published in the The Lancet. Oncology and represent the headline result of the study.
Researchers tracked outcomes across 112 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with bipolar disorder, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was an initial testing study and bipolar androgen therapy is not yet FDA-approved. The study showed promise for men whose cancer stopped responding to enzalutamide, but larger studies are needed. If you have metastatic prostate cancer that's progressed on enzalutamide, ask your oncologist about clinical trials testing this testosterone cycling approach or other available treatment options.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open bipolar disorder trials
A Study of Home-use Brain Stimulation to Treat Bipolar Depression
Bipolar depression is a long-lasting and disabling condition, and many people continue to experience depressive symptoms despite standard treatments. Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation that uses a very small electrical current applied through the scalp and has shown promise as a treatment for depression. This study aims to find out whether a home-based tDCS device is effective and safe in reducing symptoms of bipolar depression when compared with a placebo (sham) treatment. The study will also look at how acceptable the treatment is to participants and how well people are able to use the device at home. Who can participate? Adult patients aged 18 years and over who have a diagnosis of bipolar disorder and are currently experiencing a depressive episode. What does the study involve? Participants must meet specific eligibility criteria, which will be assessed by the research team. People who do not meet the study criteria or for whom tDCS is not suitable will not be able to take part. Participants will be randomly assigned to receive either active tDCS or a placebo (sham) treatment. Neither the participant nor the researchers assessing outcomes will know which treatment has been assigned. Participants will use a study device at home over a defined treatment period and will complete a series of assessments at set time points. These include clinician-rated interviews and self-reported questionnaires about mood and well-being. Device use and adherence data will be collected electronically. Participants will also be monitored for any side effects throughout their involvement in the study. Although the study is multi-site, participation is primarily remote, with most study activities completed from the participant's home. What are the possible benefits and risks of participating? Participants may experience an improvement in depressive symptoms. Information gained from this study may help improve future treatments for bipolar depression. tDCS is generally well tolerated. Possible side effects include mild and temporary sensations such as tingling, itching, headache, or skin irritation at the electrode sites. All participants will be monitored for adverse events, and appropriate support will be available if needed. Where is the study run from? The study is run from King's College London in collaboration with NHS research sites across the UK. When is the study starting and how long is it expected to run for? April 2026 to October 2027 Who is funding the study? The National Institute for Health and Care Research (NIHR), UK. Who is the main contact? Professor Cynthia Fu, the Chief Investigator at King's College London, cynthia.fu@kcl.ac.uk
Melatonin and Response to Lithium
Bipolar disorders are mental illnesses characterized by the recurrence of mood-episodes, that can have a severe impact on the life of individuals. The effect of lithium, one of the main medications used to treat acute episodes or prevent them from happening, is very different from one individual to an-other. So far, there is no way to predict in advance for whom patient this treatment will be effective or for whom it will not. Finding markers that can predict as early as possible the efficiency of this treatment is a major field of current research in psychiatry, in order to avoid maintaining an inefficient treatment for several years that can have negative side-effects. Over the past decades, it has been shown by multiple studies that lithium can act on the biological clock, that regulates circadian rhythmicity of the body (i.e. rhythms that presents a 24 hours periods, such as rhythms of sleep and activity, feeding, social activities...). But it is still very unclear whether the effect of lithium in regulating the mood in bipolar disorders is mediated by this action. Melatonin is one of the key-regulator of circadian rhythmicity of the human body. Our hypothesis, based on some previous studies, is that the action of lithium in type-1 bipolar disorder (BD-I) is related to an action on melatonin secretion. To test that, we want in this study to compare the noctunal secretion of melatonin between BD-I individuals with a good response to lithium versus with a poor response to lithium.