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Depression – Trials in Disease

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Clinical Trials for Depression: Ongoing Research and Treatment Options

There are currently 29 ongoing clinical trials investigating new treatments for depression across Europe. These studies explore various approaches including medication therapy, brain stimulation techniques, and psychological interventions for patients with different forms of depressive disorders, ranging from treatment-resistant depression to depression associated with other medical conditions.

Clinical trial locations

Esketamine Nasal Spray for Patients with Treatment-Resistant Bipolar Depression

This study in the Netherlands is examining the use of esketamine nasal spray for people with bipolar depression that has not responded to at least two different treatments. Esketamine is a medication that affects brain chemistry and may help improve mood when other treatments have not worked.

Who can participate: Adults aged 18 to 75 years with bipolar disorder (type 1 or 2) currently experiencing a depressive episode. Participants must have a depression score above 18 on a specific rating scale and have already tried at least two different antidepressant or mood-stabilizing medications without success. They must currently be taking a mood stabilizer at a stable dose for at least two weeks and be available for treatment sessions on Mondays and Fridays.

Who cannot participate: People without a bipolar disorder diagnosis during a depressive episode, those outside the age range of 18 to 65 years, individuals unable to use the nasal spray as directed, those who have not shown resistance to other bipolar depression treatments, and people in vulnerable populations who cannot give informed consent.

Treatment approach: The study involves twice-weekly administration of esketamine nasal spray (28 mg per dose) on Mondays and Fridays, given under medical supervision. Researchers will monitor the treatment’s effectiveness by measuring changes in depression scores, with success defined as at least a 50% reduction in symptoms or scores dropping below 10. The study also evaluates safety by tracking side effects and the number of participants who discontinue treatment.

Medication details: Esketamine works by affecting glutamate receptors in the brain, which may help restore neural connections and improve mood. It is being studied as an additional treatment alongside ongoing mood stabilizer medications for those with treatment-resistant bipolar depression.

Psilocybin Therapy for Hospitalized Patients with Treatment-Resistant Depression

This Belgian trial is investigating psilocybin combined with psychotherapy for people with treatment-resistant depression who are receiving inpatient addiction therapy. Psilocybin is a compound found in certain mushrooms that is being studied for its potential mental health benefits.

Who can participate: Adults aged 18 and older with moderate depression (without psychotic features) confirmed by a depression rating scale score of 20 or higher. Participants must have tried at least two different antidepressant treatments without success and be currently taking a mood stabilizer at a stable dose. They must also be admitted to the hospital for inpatient addiction therapy and have a partner willing to participate who has lived with them for at least one year. Medical stability is required, including negative alcohol and drug tests and specific heart function measurements within acceptable ranges.

Who cannot participate: Individuals with treatment-resistant depression who have not tried at least two treatments, those outside the age range of 18 to 65, people uncomfortable with psilocybin-assisted psychotherapy, those unwilling to be hospitalized for the study duration, pregnant women or those planning pregnancy, individuals with severe heart problems or serious medical conditions, those taking medications that might interact with psilocybin, people with substance abuse history, and individuals with psychiatric conditions like schizophrenia or bipolar disorder.

Treatment approach: Participants undergo preparation sessions before receiving psilocybin (28 mg) capsules during supervised therapy sessions. The treatment combines the medication with psychotherapy support to help patients explore their thoughts and feelings. Regular monitoring includes assessments of depression scores, anxiety levels, and quality of life at 3 weeks, 6 weeks, and 12 weeks after the last session. Brain activity is measured using EEG scans, and long-term follow-up continues with monthly phone calls and video consultations at 6 months and 1 year.

Medication details: Psilocybin works by interacting with serotonin receptors in the brain, particularly affecting mood and perception. It may help patients gain new perspectives during therapy sessions, potentially leading to improvements in treatment-resistant depression symptoms.

Study Comparing Lithium and Cariprazine for Treating Bipolar Depression in Patients with Bipolar Type 1 or 2 During a Depressive Episode

This Danish study compares two medications – lithium and cariprazine – for treating depressive episodes in people with bipolar disorder. Both medications are taken by mouth and are being evaluated to determine which works better for managing bipolar depression symptoms.

Who can participate: Adults aged 18 to 64 with bipolar disorder (type 1 or 2) currently experiencing a depressive episode lasting between 4 and 52 weeks. Participants must have a depression score of at least 21 on a self-reported questionnaire and should not have started or increased doses of psychotropic medications in the past two weeks (except for benzodiazepines, sleeping aids, or melatonin). They should not have begun new formal psychotherapy sessions in the past four weeks. There should be uncertainty about whether cariprazine or lithium would be the better treatment option. Female participants of childbearing age must have negative pregnancy tests and use safe birth control methods.

Who cannot participate: People not currently experiencing a depressive episode in bipolar disorder, those without a bipolar disorder diagnosis (type 1 or 2), individuals outside the specified age range, vulnerable populations, those unable to take the study medications, people with other medical conditions that might interfere with the study, those currently in another clinical trial, individuals with a history of not following medical advice, pregnant or breastfeeding women, and people with known allergies to the study medications.

Treatment approach: Participants are randomly assigned to receive either lithium or cariprazine for 8 weeks. The study uses various assessment scales to measure depression symptoms and overall well-being throughout the treatment period. Regular follow-up visits track progress and monitor for any side effects. The treatment aims to stabilize mood and reduce the severity and frequency of mood swings associated with bipolar disorder.

Medication details: Lithium is a mood stabilizer that helps balance mood swings by affecting neurotransmitter activity in the brain. Cariprazine is an antipsychotic medication that works by affecting dopamine and serotonin receptors, helping to improve mood, thinking, and behavior. Both medications are established treatments for mood disorders and are being compared to determine which is more effective for treating depressive episodes in bipolar disorder.

Study on Brain Activity in Treatment-Resistant Depression Using [18F]MC225 for Patients with Depression

This Italian study uses special brain imaging to understand why some people with depression do not respond to standard treatments. The research examines a specific protein in the brain called p-glycoprotein, which may affect how antidepressant medications work.

Who can participate: Adults aged 18 to 65 with a diagnosis of major depressive disorder and at least five years of education. Participants must be able to complete imaging procedures. For those with treatment-resistant depression, there must be a current diagnosis confirmed by lack of response to at least two previous antidepressant treatments given at the right dose and for sufficient time, where treatments did not lead to symptom disappearance. Written informed consent is required.

Who cannot participate: People outside the age range of 18 to 65, those without a depression diagnosis, individuals from vulnerable populations, those unable to undergo PET/CT scans, and people who cannot safely receive the imaging tracer.

Treatment approach: Participants receive an injection of a special imaging tracer called [18F]MC225 and undergo PET/CT scans to observe brain activity. The study compares brain images from people with treatment-resistant depression to those whose depression responds to treatment. Multiple assessments are conducted, including psychometric evaluations and repeated imaging tests, to understand how p-glycoprotein activity differs between the two groups. The study also collects blood samples to measure inflammatory markers.

Medication details: The imaging tracer [18F]MC225 is not a treatment but a diagnostic tool. It helps visualize p-glycoprotein activity in the brain by binding to this protein, allowing researchers to see how much of the tracer is taken up in different brain areas. This information may help explain why some antidepressant medications work better for certain patients than others.

Study on Brain Inflammation in Patients with Major Depressive Disorder Using 18F-DPA-714

This French study examines brain inflammation patterns in people with major depressive disorder. The research uses special imaging techniques to compare three groups: those currently experiencing depression, those in remission while taking antidepressants, and healthy individuals.

Who can participate: Men and women aged 18 to 60 who can provide written consent and understand study instructions. For the experimental group, participants must meet criteria for major depressive disorder with a depression score greater than 20 on the MADRS scale, be on antidepressant medication considered ineffective with no dosage changes for at least 2 weeks, and have medication blood levels checked. For the pathological control group, participants must have previously met depression criteria, be in remission for at least 8 weeks with a MADRS score less than 10, and be on stable antidepressant treatment. For the control group, participants must have no previous neurological or psychiatric disorders and have a CRP inflammation marker level less than 5 mg/L.

Who cannot participate: People not diagnosed with depressive disorder, those who have not been in remission for at least 8 weeks even if treated with antidepressants, individuals not matching the age and gender criteria, and those from vulnerable populations.

Treatment approach: Participants receive an injection of the imaging tracer 18F-DPA-714 through intravenous administration. Brain imaging is performed using MRI and other techniques to observe inflammation patterns. Regular assessments track depression symptoms, anxiety levels, and cognitive function using standardized scales. The study measures biological markers in blood samples to understand inflammation’s role in depression. Different groups are compared to see how brain inflammation differs between active depression, remission, and healthy states.

Medication details: The imaging tracer works by highlighting areas of brain inflammation during scans. Antidepressants used in the study help maintain mental health stability in those who are in remission, preventing the recurrence of depressive symptoms by balancing brain chemicals that affect mood and emotions.

Study on Dexamethasone for Patients with Moderate to Severe Depression: Evaluating Its Effectiveness with Mirtazapine, Citalopram, and Nortriptyline

This Danish study investigates whether adding dexamethasone, typically used for its anti-inflammatory properties, can improve symptoms when added to usual depression treatment. The research is a double-blind, randomized, placebo-controlled trial examining short-term benefits over several weeks.

Who can participate: Adults aged 18 to 64 with a diagnosis of non-psychotic, moderate to severe depressive disorder (single episode or recurrent) confirmed by a medical doctor. Participants must have a score of 22 or above on the MADRS10 depression scale, be able to give informed consent, speak Danish fluently, and currently be receiving medication for depression.

Who cannot participate: People not diagnosed with moderate to severe depression, those outside the specified age range, and individuals from vulnerable populations.

Treatment approach: Participants continue their regular depression treatment while also taking either dexamethasone or a placebo for a short period. Baseline measurements are taken on day 0, including depression severity and quality of life assessments. Follow-up assessments occur on days 4, 7, 14, and 28, measuring changes in depression symptoms using multiple rating scales. Safety monitoring tracks adverse reactions, vital signs changes, and other health outcomes. A final assessment is conducted at 28 days, with additional follow-up at 6 months to evaluate long-term outcomes.

Medication details: Dexamethasone is administered orally in tablet form as an add-on to standard care. It works by influencing the body’s stress response system, which may help alleviate depression symptoms. The study evaluates whether this anti-inflammatory medication can enhance the effects of standard antidepressant treatments when added to medications like mirtazapine, citalopram, escitalopram, nortriptyline, sertraline, venlafaxine, lithium, and quetiapine.

Study on Ketamine and CBASP for Treating Chronic Depression in Adults

This German trial examines ketamine combined with a specific type of psychotherapy called CBASP for chronic depression. The study compares this combination against placebo with CBASP and ketamine with treatment as usual to determine the most effective approach.

Who can participate: Adults aged 18 to 64 with chronic depression, defined as repeated severe or moderate depressive episodes with no full recovery between episodes for at least two months, or a current episode lasting two or more years. Participants must have treatment-resistant depression, meaning symptoms continue despite trying at least two different antidepressant medications from different categories. They must have tried at least 12 sessions of psychotherapy without achieving stable symptom relief, be able to understand and sign informed consent, follow the study visit schedule, and agree to use contraception if applicable.

Who cannot participate: People with chronic depression diagnoses, those outside the age range of 18 to 64, and individuals from vulnerable populations.

Treatment approach: Participants are randomly assigned to one of three groups: ketamine plus CBASP, placebo plus CBASP, or ketamine plus treatment as usual. Ketamine is administered intravenously twice weekly (Mondays and Fridays) at 28 mg per dose under supervision. Throughout the study, depression symptoms are assessed using standardized scales, with the primary goal of measuring symptom reduction from treatment start to six weeks after completion. Follow-up assessments monitor for relapse and long-term treatment effects.

Medication details: Ketamine works by blocking NMDA receptors in the brain, which may help restore neural connections and rapidly reduce depressive symptoms. CBASP is a psychotherapy specifically designed for chronic depression that helps patients understand how their behavior impacts others and learn new problem-solving approaches. The combination aims to provide both quick symptom relief and longer-term behavioral changes.

Study on Ketamine and Midazolam for Adults with Depression and Alcohol Use Disorder

This Norwegian study evaluates ketamine’s effects on individuals with both depression and alcohol use disorder who are receiving inpatient addiction therapy. The trial compares ketamine to a control medication to assess its impact on depression symptoms and alcohol cravings.

Who can participate: Adults aged 18 to 65 with at least moderate depression without psychotic features and alcohol dependence as their primary substance use disorder. Participants must be admitted to the hospital for inpatient addiction therapy at University Hospital of North Norway, have no alcohol in their system on treatment day (confirmed by breath test), and have a negative drug test the day before treatment. Female participants must have negative pregnancy tests.

Who cannot participate: Individuals not diagnosed with both depression and alcohol use disorder, those not admitted for addiction therapy, people outside the age range of 18 to 65, and those from vulnerable populations.

Treatment approach: Participants receive treatment through intravenous infusion with either ketamine or midazolam. Depression symptoms are measured using the MADRS scale from the study start to within three days after the final treatment session. Secondary outcomes include changes in alcohol craving, alcohol consumption, and cognitive function, as well as the frequency and severity of adverse reactions. Follow-up assessments evaluate alcohol consumption changes from three months before admission to six months after treatment.

Medication details: Ketamine is administered intravenously and works by blocking NMDA receptors in the brain, which can lead to rapid improvements in mood and cognition. It is being studied for its potential to quickly reduce depression symptoms while patients are also receiving treatment for alcohol use disorder. Midazolam, used as a control, is a sedative that helps with anxiety but does not have the same antidepressant properties as ketamine.

Study on Psilocybin, Ketamine, and Midazolam for Treating Depression in Cancer Patients

This Czech study examines three different treatments for depression in cancer patients: psilocybin, ketamine, and midazolam. The research aims to determine which treatment most effectively reduces depression symptoms in individuals dealing with both cancer and depression.

Who can participate: Men and women aged 18 to 75 with depressive syndrome occurring alongside an oncological disease that is either at an advanced stage, has a poor prognosis (expected survival of 5 years or less), is currently worsening, has returned after treatment, or is in a controlled phase but at least 6 months have passed since diagnosis. Participants who have not used standard antidepressants, are using antidepressants for at least 6 weeks at stable doses without improvement, or have tried psychosocial interventions without improvement may join. They must be able to understand study information and questionnaires, and have a caregiver who will accompany them to the first visit, pick them up after sessions, maintain personal contact at least 5 days weekly, and be available throughout the trial. Participants of childbearing age must use prescribed contraception methods.

Who cannot participate: Pregnant or breastfeeding women, individuals with severe allergic reactions to study medications, people with unstable medical conditions, those who have used certain interfering medications within a specific timeframe, individuals with substance abuse or dependency history, people who participated in another clinical trial recently, those with certain interfering mental health conditions, and people unable to comply with study procedures.

Treatment approach: After a preparation session 9 to 7 days before the first medication administration, participants receive either psilocybin 25 mg, ketamine hydrochloride, or midazolam in hard capsule form taken orally. The effects are monitored using various scales including MADRS, BECK, and FACIT at multiple time points: day 1, day 4, 1 week, 4 weeks, 8 weeks, 16 weeks, and 24 weeks. The study evaluates antidepressant effects, changes in quality of life, and the impact of acute psychological effects during sessions. Safety is assessed by monitoring vital signs, adverse events, and changes in mental health and behavior. Participants may enter an open-label extension where only psilocybin and ketamine are compared.

Medication details: Psilocybin works by affecting serotonin receptors in the brain, potentially helping patients explore their feelings in new ways during therapy. Ketamine blocks NMDA receptors, providing rapid antidepressant effects. Midazolam enhances GABA effects in the brain for sedation and anxiety relief, serving as a control to compare the other treatments’ effectiveness.

Study on the Early Effects of Ketamine and Venlafaxine for Hospitalized Patients with Severe Major Depression

This French study investigates whether adding ketamine to venlafaxine treatment can speed up improvement in severe depression symptoms. The research uses brain imaging to understand the biological changes associated with treatment response.

Who can participate: Adults aged 18 to 65 with a current major depressive episode as part of Major Depressive Disorder according to DSM-5 criteria. Participants must be hospitalized for this episode, have a minimum depression score of 24 on the HDRS scale, be in a situation where starting treatment with venlafaxine is recommended, and be members of a social security scheme. Women of childbearing age must use effective contraception throughout the study.

Who cannot participate: People without a severe major depressive episode, those not taking venlafaxine, individuals not hospitalized for their severe depression, people under 18 years old, and those from vulnerable populations.

Treatment approach: Participants receive venlafaxine orally while also being randomly assigned to receive either ketamine or placebo through intravenous administration over 7 days. Depression symptoms are assessed using the HDRS scale at baseline and after treatment. PET-MRI scans are performed before and after treatment to observe brain changes. Follow-up assessments measure treatment response, hospital stay length, and any side effects. The study focuses on short-term effects over the first two weeks, with particular attention to blood pressure, heart rate, and other potential adverse effects during and after ketamine administration.

Medication details: Ketamine is administered intravenously and works by blocking NMDA receptors in the brain, which can lead to rapid improvements in depression symptoms. Venlafaxine is taken orally and works by inhibiting the reuptake of serotonin and norepinephrine, helping to balance neurotransmitters and improve mood. The study examines whether combining these medications leads to faster and more effective treatment than using venlafaxine alone.

Study on the Effectiveness of Choline Alfoscerate for Treating Mild Depression in Elderly Patients

This Italian study examines choline alfoscerate for treating subthreshold depression in older adults. Subthreshold depression means having some depression symptoms but not enough for a full major depression diagnosis.

Who can participate: Individuals aged 65 years or older who have experienced 2 to 4 depressive symptoms for at least two weeks before joining. Participants must have a Mini-Mental State Examination score of 24 or higher and a Montreal Cognitive Assessment score of less than 26. They must be able to understand the study and sign an informed consent form.

Who cannot participate: People who are not elderly, those without subthreshold depression, and individuals from vulnerable populations.

Treatment approach: Participants receive choline alfoscerate in soft capsule form (GLIATILIN 600) taken orally. The study lasts up to 8 weeks, during which time depression and cognitive symptoms are monitored using various assessment scales including the Hamilton Depression Rating Scale, Geriatric Depression Scale, Clinical Global Impression-severity scale, and Montreal Cognitive Assessment scale. Baseline measurements are taken at the start, with regular follow-up assessments to track changes from baseline. A final evaluation at the end determines the treatment’s effectiveness.

Medication details: Choline alfoscerate works by increasing acetylcholine levels in the brain, a neurotransmitter important for memory and learning. By improving brain chemistry, it may help enhance mood and cognitive function in elderly patients with mild depression symptoms. The medication is being studied to determine if it can provide relief for older adults who do not meet full criteria for major depression but still experience troublesome symptoms.

Summary

The 29 ongoing clinical trials for depression span multiple European countries, with notable concentrations in France (8 trials), Italy (7 trials), and Germany (3 trials). The research demonstrates a diverse approach to treating various forms of depression, including treatment-resistant depression, bipolar depression, and depression associated with other medical conditions.

A significant focus of current research involves psychedelic substances, particularly psilocybin, which is being studied in multiple trials across Belgium, Austria, France, Italy, and Czechia. These studies often combine the medication with psychotherapy support to enhance therapeutic outcomes. Additionally, ketamine-based treatments feature prominently, with several trials examining its use alone or in combination with other therapies such as electroconvulsive therapy or CBASP psychotherapy.

The trials also explore augmentation strategies, where new medications are added to existing antidepressant treatments. Examples include the study of OSU6162 added to SSRI/SNRI medications in Sweden, aticaprant combined with antidepressants across multiple countries, and dexamethasone added to standard depression treatments in Denmark.

Several trials focus on special populations or specific forms of depression, including elderly patients with subthreshold depression in Italy, cancer patients with depression in Czechia, patients with both depression and alcohol use disorder in Norway, and heart failure patients experiencing depression in Poland. There are also studies examining ways to safely discontinue antidepressant medications in Italy and optimize electroconvulsive therapy outcomes in the Netherlands and Denmark.

The geographic distribution shows strong research activity in Western and Southern Europe, with fewer trials in Northern and Eastern Europe. This may reflect differences in research infrastructure, funding availability, and regulatory frameworks across European regions. The variety of approaches being studied reflects the complexity of depression as a condition and the recognition that different patients may respond to different treatment strategies.

Ongoing Clinical Trials on Depression

  • Study of Flumazenil to Reduce Side Effects of Electroconvulsive Therapy in Patients with Depression

    Recruiting

    1 1 1 1
    Investigated diseases:
    Denmark

  • Study on the Effects of Semaglutide on Mood in Patients with Major Depressive Disorder and Overweight or Obesity

    Recruiting

    1 1 1
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    Investigated drugs:
    Denmark

  • Study on Brain Activity in Treatment-Resistant Depression Using [18F]MC225 for Patients with Depression

    Recruiting

    1 1
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    Investigated drugs:
    Italy

  • Study on the Effectiveness of Choline Alfoscerate for Treating Mild Depression in Elderly Patients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Italy

  • Study on Psilocybin, Ketamine, and Midazolam for Treating Depression in Cancer Patients

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia

  • Study on Dexamethasone for Patients with Moderate to Severe Depression: Evaluating Its Effectiveness with Mirtazapine, Citalopram, and Nortriptyline

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Safe Discontinuation of Antidepressants in Patients with Remitted Depression: Amitriptyline, Fluoxetine, Paroxetine, and Drug Combination Study

    Recruiting

    1 1 1 1
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    Investigated drugs:
    Italy

  • Testing dehydroepiandrosterone combined with standard antidepressants for patients with treatment-resistant depression

    Not yet recruiting

    1 1 1
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    Germany

  • A study on the effects of support and music during psilocybin therapy for people with depression.

    Not yet recruiting

    1 1
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    Investigated drugs:
    Denmark

  • Study of prucalopride and escitalopram combination to improve treatment response in patients with major depressive disorder

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

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