Ongoing Clinical Trials for Mental Disorders
This article provides information about 9 ongoing clinical trials investigating various treatments for mental disorders, including depression, anxiety, PTSD, and cognitive impairment. These studies are taking place across multiple European countries and are exploring both new medications and established treatments to improve outcomes for patients with mental health conditions.
Clinical trial locations
- Bulgaria
- Czechia
- Finland
- France
- Study on Long-term Safety and Effectiveness of NMRA-335140 for Patients with Major Depressive Disorder
- Study on Rituximab for Patients with Mental Disorders and Autoimmunity
- Study on the Effects of NMRA-335140 for Adults with Major Depressive Disorder
- Study on Treating Anemia After Cesarean with Ferric Carboxymaltose or Oral Iron in Women with Moderate Iron Deficiency Anemia
- Germany
- Italy
- Study on Choline Alfoscerate for Patients with Mild Cognitive Impairment
- Study on the Effectiveness and Safety of Ademetionine Injections for Patients with Major Depressive Disorder Not Responding to Antidepressants
- Study on the Effectiveness and Safety of Ademetionine with Antidepressants for Patients with Major Depressive Disorder
- Netherlands
- Norway
- Poland
- Sweden
Study on Ketamine and Midazolam for Adults with Depression and Alcohol Use Disorder
This trial is investigating the effectiveness of ketamine in treating depression among adults who also struggle with alcohol dependence and are receiving inpatient addiction therapy.
Main inclusion criteria: Participants must be between 18 and 65 years old with at least moderate depression without psychotic features and alcohol dependence as their primary substance use disorder. They must be admitted to the hospital for inpatient addiction therapy at University Hospital of North Norway.
Main exclusion criteria: Individuals without both depression and alcohol use disorder, those not admitted for addiction therapy, those outside the specified age range, and those considered part of a vulnerable population are excluded from participation.
Trial focus: The study evaluates how ketamine affects depression symptoms in individuals with co-occurring alcohol use disorder during their addiction treatment. The primary outcome measures changes in depression symptoms using the MADRS scale from the start of treatment to within three days after the final treatment session. Secondary outcomes include changes in alcohol craving, consumption patterns, neurocognitive function, and any adverse reactions.
Investigational drug: Ketamine is administered intravenously to assess its potential to reduce symptoms of depression in this specific patient population. The study compares ketamine treatment with midazolam (used as a control) to determine effectiveness.
Study on Long-term Safety and Effectiveness of NMRA-335140 for Patients with Major Depressive Disorder
This trial examines the long-term safety and effectiveness of NMRA-335140, a medication taken as a film-coated tablet once daily, in patients with Major Depressive Disorder.
Main inclusion criteria: Participants must have completed a previous NMRA-335140 Phase 3 study and signed an informed consent form. In certain locations like the Czech Republic, a caregiver must be available to assist with monitoring and accompany the participant to study visits. Participants must also agree to follow birth control and medication guidelines from the previous study.
Main exclusion criteria: Patients with other serious mental health conditions besides Major Depressive Disorder, a history of drug or alcohol abuse, certain medical conditions that could interfere with the study medication, pregnant or breastfeeding women, those participating in another clinical trial, individuals who have had recent major surgery, and those unable to follow study procedures are excluded.
Trial focus: The study assesses how well NMRA-335140 is tolerated by participants over 52 weeks. Regular assessments monitor safety through checking for adverse events, laboratory tests, physical examinations, electrocardiograms, eye examinations, and questionnaires. Effectiveness is evaluated using various scales including the Montgomery-Åsberg Depression Rating Scale, Snaith-Hamilton Pleasure Scale, and Patient Health Questionnaire-9.
Investigational drug: NMRA-335140 is administered as an 80 mg film-coated tablet taken once daily by mouth. The medication is being studied for its safety and long-term effectiveness in treating Major Depressive Disorder.
Study on Rituximab for Patients with Mental Disorders and Autoimmunity
This trial investigates whether rituximab, an immunotherapy medication, can benefit patients with mental disorders that are believed to be linked to immune system problems.
Main inclusion criteria: Adults and adolescents aged 17 or older experiencing their first episode or relapse of psychotic disorders, and children aged 6-16 with similar conditions, can participate. For the second part of the study, participants must have harmful CNS autoantibodies in their blood, a score greater than 3 on the MDC scale, and for those with heart disease history, a normal ECG is required. Women of childbearing potential must use effective birth control during the study and for at least 12 months after the last dose.
Main exclusion criteria: Patients with other serious medical conditions, those who are pregnant or breastfeeding, individuals with a history of severe allergic reactions to any medication, those currently in another clinical trial, patients with uncontrolled substance abuse problems, those who have had major surgery within the last 3 months, patients with unstable psychiatric conditions requiring immediate intervention, and those unable to provide informed consent due to cognitive impairment are excluded.
Trial focus: The study evaluates whether rituximab, given as an infusion, can improve psychiatric symptoms when added to standard psychiatric care. The primary goal is to assess remission of psychiatric symptoms over 3 months. For adults and adolescents, a 20% decrease from baseline on the BPRS-E scale is targeted, while for children, a 25% decrease on the ABC scale is aimed for.
Investigational drug: Rituximab is an immunotherapy administered as a solution for infusion. It helps modify the immune system and is being tested to see if it can improve mental health symptoms in patients with proven auto-immunity.
Study on the Effectiveness and Safety of Ademetionine Injections for Patients with Major Depressive Disorder Not Responding to Antidepressants
This trial tests whether Samyr injections, containing ademetionine, can enhance the effects of existing antidepressant medications in patients who haven’t experienced sufficient improvement in their symptoms.
Main inclusion criteria: Patients must provide written informed consent and be between 18 and 65 years old. They must have a primary diagnosis of Major Depression Disorder for at least 12 weeks according to DSM-5 criteria. Participants should be taking a prescribed SSRI or SNRI antidepressant at an approved and stable dose for at least 4 weeks, with less than 50% symptom reduction. At screening, they must have a MADRS score of at least 22, with less than 15% reduction at baseline, and a score of 19 or higher at randomization.
Main exclusion criteria: Patients with a different condition than Major Depression Disorder, those not within the specified age range, and individuals considered part of a vulnerable population are excluded.
Trial focus: The study is a double-blind trial comparing Samyr intramuscular injections (400 mg/5ml) with placebo injections. The primary focus is on changes in the MADRS score after 7 days of treatment, with regular monitoring visits to assess progress and effectiveness.
Investigational drug: Samyr IM contains ademetionine and is administered through intramuscular injection. It is being tested as an additional treatment to help improve the effects of antidepressants in patients with Major Depressive Disorder.
Study on the Effectiveness and Safety of Ademetionine with Antidepressants for Patients with Major Depressive Disorder
This trial evaluates whether Samyr tablets, when used alongside other antidepressant treatments, can improve symptoms in patients with mild to moderate Major Depressive Disorder.
Main inclusion criteria: Patients must be between 18 to 65 years old and provide written informed consent. They must have a primary diagnosis of Major Depression Disorder for at least 12 weeks, confirmed by the Mini International Neuropsychiatric Interview. Participants should be taking a prescribed SSRI or SNRI antidepressant at an approved and stable dose for at least 4 weeks, with inadequate response showing less than 50% symptom reduction. They must have a Hamilton Depression Rating Scale score between 15-20 at screening, with no more than a 10% reduction between screening and baseline.
Main exclusion criteria: Patients with an HDRS-17 score outside the range of 15-20, those with more than 10% reduction in their score at baseline, patients who have had adequate response to antidepressants, those not between 18 and 65 years old, and individuals considered part of a vulnerable population are excluded.
Trial focus: This is a six-week double-blind trial where participants receive either Samyr 400 mg gastro-resistant tablets or placebo tablets, in addition to their current antidepressant treatment. Weekly visits monitor changes in symptoms and side effects using scales such as the Patient Global Impression and Clinical Global Impression.
Investigational drug: Samyr is administered as a tablet taken orally once daily for six weeks. It contains ademetionine and is being studied for its potential to improve depressive symptoms when used alongside other antidepressant treatments.
Study on the Effects of NMRA-335140 for Adults with Major Depressive Disorder
This trial investigates the effectiveness of NMRA-335140, a kappa opioid receptor antagonist, in reducing symptoms of depression compared to placebo.
Main inclusion criteria: Participants must have a primary diagnosis of Major Depressive Disorder without psychotic features, confirmed by structured clinical interview and independent assessment. The current depressive episode must have been present for more than 4 weeks but less than 12 months before screening. Patients must have a MADRS total score of 25 or higher at both screening and baseline visits, with no more than 20% change between these visits.
Main exclusion criteria: Patients with mental health conditions other than Major Depressive Disorder, those outside the specified age range, individuals unable to follow study procedures or take medication as required, those with medical conditions that could interfere with the study drug, pregnant or breastfeeding women, those currently in another clinical trial, patients with a history of substance abuse that could interfere with the study, and those who have had or are planning major surgery during the study period are excluded.
Trial focus: This is a six-week double-blind trial where participants are randomly assigned to receive either NMRA-335140 (80 mg per day) or placebo. The primary goal is to evaluate changes in the MADRS total score from baseline to week 6. Secondary evaluations include changes in the Snaith-Hamilton Pleasure Scale total score.
Investigational drug: NMRA-335140 is a kappa opioid receptor antagonist administered orally as a film-coated tablet. It works by blocking certain receptors in the brain that are thought to be involved in mood regulation.
Study on Treating Anemia After Cesarean with Ferric Carboxymaltose or Oral Iron in Women with Moderate Iron Deficiency Anemia
This trial compares intravenous iron (Ferinject) with oral iron treatments (Timoferol) to assess their effects on the prevalence of postpartum depression at 8 weeks after delivery in women with moderate iron deficiency anemia following caesarean section.
Main inclusion criteria: Women must have given birth by caesarean delivery, be at least 18 years old, and have been pregnant for at least 32 weeks before delivery. They must have a postoperative hemoglobin level between 8.0 g/dL and 10.0 g/dL within 72 hours after delivery, and ferritin of 100 ng/mL or less or transferrin saturation of 20% or less. Participants must be hospitalized in the postpartum maternity ward, have national social security coverage, and have an EPDS score of less than 11 with a “never” answer to question 10.
Main exclusion criteria: Women who have not delivered by caesarean section, those without moderate postpartum iron deficiency anemia (blood levels outside specified ranges), individuals outside the age range, men, and those considered part of a vulnerable population are excluded.
Trial focus: The study monitors participants over 8 weeks to observe changes in their condition and evaluate treatment effectiveness. Initial assessments confirm moderate iron deficiency anemia through blood tests within 72 hours after delivery. Participants are randomly assigned to receive either oral or intravenous iron treatment, with regular monitoring for side effects, hemoglobin levels, ferritin levels, and fatigue scores. The primary outcome assesses symptoms of postpartum depression using the Edinburgh Postpartum Depression Scale at 8 weeks, with long-term follow-up at 6 months.
Investigational drugs: Intravenous iron (Ferinject containing ferric carboxymaltose) is delivered directly into the bloodstream to quickly increase iron levels. Oral iron (Timoferol) is taken by mouth in tablet or capsule form to gradually increase iron levels. Both treatments aim to reduce the risk of postpartum depression in women with moderate iron deficiency anemia.
Study on Cannabidiol for Reducing Anxiety and PTSD Symptoms in Dutch Uniformed Personnel
This trial explores whether a two-week course of Cannabidiol can help reduce anxiety symptoms before starting therapy for anxiety or PTSD in Dutch uniformed personnel.
Main inclusion criteria: Participants must be members of the Dutch uniformed personnel, such as police officers, firefighters, ambulance paramedics, military personnel, or veterans. They must be between 18 and 65 years old and waiting for therapy to treat a trauma and stressor-related disorder or an anxiety disorder, as determined by the MINI PLUS psychiatric interview.
Main exclusion criteria: People with certain psychological disorders such as PTSD or anxiety disorders cannot participate (this appears to be an error in the source data as these are the conditions being studied), individuals not within the specified age range, participants who do not belong to the specified clinical trial groups, and those considered part of a vulnerable population are excluded.
Trial focus: Participants take CBD capsules daily for two weeks, during which researchers monitor changes in anxiety levels using Beck’s anxiety index. The study also assesses how CBD affects fear responses, stress regulation, and sleep quality through questionnaires, physiological measurements, and sleep watches.
Investigational drug: Cannabidiol is a natural compound from the cannabis plant, administered in capsule form. It is being studied for its potential calming effects and ability to reduce anxiety symptoms before participants begin other treatments for anxiety or PTSD.
Study on Choline Alfoscerate for Patients with Mild Cognitive Impairment
This trial examines whether Choline Alfoscerate can slow down or stabilize changes in brain areas involved in memory and improve cognitive abilities in individuals with mild cognitive dysfunction.
Main inclusion criteria: Patients must be at least 65 years old, able to understand and sign an informed consent form (along with a family member or caregiver), and have memory problems verified by neuropsychological testing with specific scores: Mini Mental State Evaluation score of 24 or higher and Clinical Dementia Rating score of 0.5. They must have sufficient education to read, write, and communicate effectively, be independent in daily activities, be cooperative, live with or be in contact with a family member or caregiver, and have had an MRI within six months before joining. Participants must also have at least two vascular risk factors such as high blood pressure, diabetes, obesity, heart disease, high cholesterol, high homocysteine levels, smoking, previous stroke, or family history of cardiovascular diseases.
Main exclusion criteria: Patients with severe cognitive dysfunction, other serious neurological disorders, severe psychiatric disorders, uncontrolled medical conditions, those who are pregnant or breastfeeding, participants in another clinical trial, those with a history of drug or alcohol abuse, and patients who have had a recent stroke are excluded.
Trial focus: The study monitors participants to assess the effects of Choline Alfoscerate on brain structure and cognitive abilities. Regular monitoring evaluates hippocampal atrophy, entorhinal cortex, neocortex, and ventricular dilation using MRI imaging. Cognitive abilities are assessed using neuropsychological scales to evaluate executive, memory, visual-constructive, linguistic, and attentional functions, along with functional performance, mood, and motivation.
Investigational drug: Choline Alfoscerate is a cholinergic precursor administered as an oral solution. It helps increase levels of acetylcholine in the brain, a chemical important for memory and learning. The study aims to determine if this medication can slow down or stabilize changes in brain areas involved in memory.
Summary
These 9 ongoing clinical trials represent diverse approaches to treating various mental health conditions across Europe. The studies span multiple countries, with the highest concentration of trials in France, which hosts four studies, followed by several countries in Central and Eastern Europe participating in multi-national trials.
A notable pattern is the focus on depression treatments, with several trials investigating new approaches for Major Depressive Disorder. NMRA-335140, a kappa opioid receptor antagonist, appears in two large multi-country studies examining both short-term effectiveness and long-term safety. Additionally, ademetionine (Samyr) is being evaluated in two Italian trials, one using injections and another using tablets, both targeting patients who have not fully responded to standard antidepressants.
The trials also address specialized populations and conditions. One Norwegian study examines ketamine for patients with both depression and alcohol use disorder, while a Dutch trial investigates cannabidiol for uniformed personnel with anxiety and PTSD symptoms. A French study explores the unique connection between immune system dysfunction and mental disorders through rituximab treatment.
Interestingly, one trial takes an indirect approach to mental health by studying whether treating iron deficiency anemia after caesarean delivery can reduce the risk of postpartum depression. Another Italian study focuses on cognitive impairment in elderly patients with vascular risk factors.
These trials reflect the evolving understanding that mental health conditions require diverse treatment strategies, from targeting specific brain receptors to addressing underlying physical conditions and immune system factors.
