Ongoing Clinical Trials for Bipolar Disorder
Currently, there are 10 ongoing clinical trials investigating various treatment approaches for bipolar disorder. These studies are testing different medications including mood stabilizers, antipsychotics, and novel therapeutic compounds across multiple countries in Europe. The trials focus on treating different aspects of the condition, from acute manic episodes to depressive phases and long-term mood stabilization.
Clinical trial locations
- Austria
- Bulgaria
- Croatia
- Denmark
- France
- Germany
- Greece
- Italy
- Study on the Effect of Citalopram, Sertraline, and Lithium for Patients with Bipolar Depression After First-Line Treatment Failure
- Study on Enhanced Treatment for Schizophrenia, Depression, and Bipolar Disorder Using Esketamine, Bupropion, and Quetiapine for Patients with Initial Treatment Failure
- Study on Memantine Hydrochloride for Adolescents with Bipolar Disorder
- Poland
- Romania
- Spain
- Sweden
Study Comparing Lithium and Lamotrigine for Mood Stabilization in Patients with Bipolar Disorder Type II
This trial, conducted in Denmark, compares two established mood stabilizers in patients with Type II disorder. Participants must be newly diagnosed adults between 18 and 70 years old who speak Danish or English fluently. The study accepts patients who are currently experiencing depressive episodes, hypomanic episodes, or are in remission. The diagnosis must be confirmed through a structured clinical interview.
The main goal is to determine which medication provides better mood stabilization and prevents relapses over six months. Participants will be randomly assigned to receive either lithium carbonate or lamotrigine in tablet form. The study monitors mood changes daily through a specialized system and uses standardized rating scales to measure symptoms.
The medications being tested are lithium, a well-established mood stabilizer that works by affecting neurotransmitter activity in the brain, and lamotrigine, an anticonvulsant that helps prevent mood episodes, particularly depressive ones. Both medications are taken orally once daily.
Study on Amiloride for Treating Nephrogenic Diabetes Insipidus in Bipolar Disorder Patients on Long-term Lithium Therapy
This French study addresses a specific complication that can arise from long-term lithium treatment. Participants must be adults aged 18 to 70 who have been taking lithium for at least five years and have developed nephrogenic diabetes insipidus, a condition where the kidneys cannot concentrate urine properly. This leads to excessive urination and thirst.
The trial tests whether amiloride, a potassium-sparing diuretic, can help reduce this urine concentration problem. Participants will continue their lithium treatment while adding amiloride or a placebo. The study will monitor improvements in urine concentration, nighttime urination frequency, thirst levels, and overall quality of life over 12 months, with key assessments at 2, 6, and 12 months.
Women of childbearing age must use effective contraception throughout the 12-month study period.
Study on Lumateperone for Treating Manic Episodes in Bipolar I Disorder Patients
This study, conducted in Bulgaria and Croatia, examines a newer medication for treating acute manic episodes. Participants must be hospitalized adults aged 18 to 75 currently experiencing a manic episode or mania with mixed features. The episode must have started within four weeks of screening, and patients must score 20 or higher on the Young Mania Rating Scale.
The trial compares lumateperone, an atypical antipsychotic that modulates serotonin, dopamine, and glutamate pathways in the brain, to a placebo over three weeks. The medication is taken as a 42 mg capsule once daily. The study measures changes in manic symptoms from baseline to the end of the treatment period.
Patients must be hospitalized voluntarily and cannot have been admitted more than 14 days before screening. Those with substance abuse issues, allergies to the study medication, or who are pregnant or breastfeeding cannot participate.
Study on Lumateperone for Treating Manic Episodes in Bipolar I Disorder Patients
This parallel study in Romania and Bulgaria has an identical design to the previous trial, also testing lumateperone for acute manic episodes. The inclusion and exclusion criteria are the same, requiring hospitalized adults with confirmed manic episodes and specific symptom severity scores.
Like the Croatian-Bulgarian study, this trial is double-blind and placebo-controlled, lasting three weeks. Participants receive either lumateperone 42 mg or matching placebo capsules daily. The primary measure of success is reduction in manic symptoms as measured by standardized rating scales.
Study on the Effect of Citalopram, Sertraline, and Lithium for Patients with Bipolar Depression After First-Line Treatment Failure
This multi-country study across Germany, Greece, Italy, and Spain focuses on patients experiencing their first treatment failure for bipolar depression. Participants must be at least 18 years old with confirmed Type I or Type II disorder currently in a depressive episode. They must have tried a first-line treatment for at least four weeks at the recommended dose without adequate response.
The trial compares an early-intensified treatment approach to standard care over six weeks. The intensified approach may involve medications such as escitalopram, sertraline, venlafaxine, quetiapine, sodium valproate, or bupropion. Participants must have significant symptom severity, scoring 20 or higher on the Montgomery Åsberg Depression Rating Scale and showing functional impairment.
Women who can become pregnant must use effective birth control, as must men taking valproate. The study monitors depression severity, functional ability, and quality of life throughout the treatment period.
Study on the Effects of Low-Dose Acetylsalicylic Acid in Patients with Bipolar Disorder
This Polish study explores whether low-dose aspirin can help when added to standard treatment. Participants must be adults aged 18 to 60 currently experiencing a depressive episode and already taking mood stabilizers (except valproates). The study requires a body mass index between 18 and 40.
The trial tests acetylsalicylic acid (aspirin) at 150 mg daily in gastro-resistant tablet form as an add-on therapy. The treatment has two phases: a short-term 2-month phase focused on treating depression, and a long-term 12-month phase aimed at preventing relapses. The study measures depression severity, relapse rates, and suicide attempt frequency.
Women of childbearing age must have negative pregnancy tests and agree to use highly effective contraception, as some mood stabilizers like carbamazepine can interfere with hormonal birth control.
Study on the Long-term Use of Pramipexole for Patients with Anhedonic Depression
This Swedish study focuses on long-term treatment of anhedonic depression, where patients struggle to feel pleasure in activities. Participants must have previously completed a short-term study comparing pramipexole to placebo. Those who received pramipexole and wish to continue, or those who received placebo and meet specific criteria for anhedonia, can join.
The trial tests pramipexole, a dopamine agonist that stimulates dopamine receptors in the brain to improve mood and motivation. The medication is taken as prolonged-release tablets orally. The study lasts up to 25 weeks and monitors mood stability, physical activity, sleep patterns, and side effects.
Participants must be adults aged 18 to 65 who can provide informed consent. Those receiving placebo in the previous study must score 3 or 4 on at least three items of a specific pleasure scale to demonstrate significant anhedonia.
A Study of OSU6162 in Adults with Bipolar Depression to Evaluate Safety and Effectiveness
This Swedish study examines a novel compound for bipolar depression. Participants must be adults aged 18 to 65 currently experiencing a depressive episode, with a diagnosis confirmed by structured interview. They must score 10 or higher on a specific depression scale and must be on a stable dose of one mood stabilizer (lithium, lamotrigine, valproate, or carbamazepine) for at least four weeks.
OSU6162 is a dopamine stabilizer that works by normalizing neurotransmitter activity rather than simply increasing or decreasing it. Participants take 15 mg coated tablets orally while continuing their mood stabilizer. The study involves staying in a psychiatric ward during the 60-day treatment period, with regular assessments on days 0, 5, 12, 30, 45, and 60.
Women who can become pregnant must use highly effective birth control, and men must use condoms during the study and for two weeks afterward.
Study on Enhanced Treatment for Schizophrenia, Depression, and Bipolar Disorder Using Esketamine, Bupropion, and Quetiapine for Patients with Initial Treatment Failure
This multi-country study across Austria, Germany, Italy, and Spain tests intensified treatment approaches for patients who haven’t responded to initial therapy. For those with bipolar depression, participants must be at least 18 years old with confirmed diagnosis and experiencing their first treatment failure after at least four weeks on a first-line medication.
The trial compares intensified treatment to standard care over four to six weeks. The intensified approach may include medications such as esketamine (nasal spray), quetiapine, venlafaxine, sertraline, duloxetine, escitalopram, or lithium. Participants must have moderate symptom severity and functional impairment. The study measures changes in symptoms from baseline to end of treatment.
Female participants of childbearing age must use effective contraception throughout the study period.
Study on Memantine Hydrochloride for Adolescents with Bipolar Disorder
This Italian study uniquely focuses on adolescents aged 13 to 17 with mild to moderate bipolar symptoms. Participants must have confirmed diagnosis of Type I, Type II, cyclothymic disorder, or unspecified type, currently experiencing manic, mixed, or hypomanic symptoms without psychotic features. They must score between 20 and 40 on the Young Mania Rating Scale.
The trial tests memantine, typically used for Alzheimer’s disease but being explored here as a mood stabilizer. It works by blocking specific receptors in the brain involved in mood regulation. The medication is given as 10 mg film-coated tablets taken orally. The study lasts up to 52 weeks, with a 12-week treatment phase followed by extended observation.
Both the adolescent and a parent or legal representative must consent to participation. Girls who can become pregnant must have negative pregnancy tests and use effective birth control throughout the study.
Summary
These 10 clinical trials represent diverse approaches to managing different aspects of bipolar disorder across Europe. The studies are distributed across 12 countries, with Germany, Italy, and Spain hosting multiple trials. Sweden stands out as the only country conducting research on novel compounds like OSU6162 and long-term dopamine agonist therapy.
Several trials focus on treatment-resistant patients who have not responded to initial therapy, reflecting an important clinical need. Multiple studies test lumateperone, an atypical antipsychotic, suggesting industry interest in this compound for acute manic episodes. Traditional mood stabilizers like lithium and lamotrigine continue to be studied, particularly for Type II disorder and long-term maintenance.
Notably, one trial specifically addresses adolescents, filling a gap in research for younger patients. Another trial uniquely focuses on managing lithium’s side effects rather than the disorder itself, highlighting the importance of long-term medication tolerability. The diversity of study designs, from short-term acute treatment trials to year-long maintenance studies, reflects the multifaceted nature of managing this chronic condition.
