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Study on Buprenorphine for Treating Severe Suicidal Thoughts in Patients with Major Depression

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication buprenorphine for individuals experiencing severe suicidal thoughts during a major depressive episode. A major depressive episode is a period characterized by a severely low mood that affects daily functioning. The study aims to determine if buprenorphine, which is typically used for pain relief, can help reduce suicidal thoughts when added to the current treatment plan. Participants in the study will receive either buprenorphine or a placebo to compare the effectiveness of the medication.

The study will explore two different doses of buprenorphine: 0.8 mg and 0.4 mg, taken as a sublingual tablet, which means it is placed under the tongue to dissolve. The goal is to find out which dose is more effective in reducing suicidal thoughts. The study will last for several weeks, during which participants will be closely monitored for any changes in their symptoms and overall well-being. Regular assessments will be conducted to track the progress of the participants, including evaluations of their mood and any side effects they may experience.

Throughout the study, participants will undergo various assessments, including psychological evaluations and possibly MRI scans, to gather comprehensive data on the effects of the treatment. The study will also collect blood and stool samples to create a biobank, which is a collection of biological samples used for research purposes. The information gathered from this trial will help researchers understand the potential benefits of using buprenorphine as an additional treatment for severe suicidal thoughts in people with major depressive episodes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age (18-65 years), hospitalization status, and diagnosis of a major depressive episode without psychotic features. A Montgomery-Asberg Depression Rating Scale (MADRS) score greater than 20 and a Scale for Suicidal Ideation (SSI) score greater than 8 are required.
Informed consent must be provided, and health insurance coverage is verified.
Step 2
Treatment phase
The treatment involves the administration of buprenorphine at analgesic doses. The medication is taken orally.
Two dosages are tested: 0.8 mg and 0.4 mg. The specific dosage and frequency are determined by the study protocol.
Step 3
Primary evaluation
The primary evaluation occurs on Day 7 (D7). The main objective is to assess the effect of buprenorphine compared to a placebo on suicidal thoughts.
The Scale for Suicidal Ideation (SSI) is used to measure changes in suicidal thoughts over the past 7 days.
Step 4
Secondary evaluations
Secondary evaluations are conducted from Day 7 to Day 42. These include SSI scores, psychological pain evaluation using a Visual Analog Scale (PPP-VAS), and scores on the Beck Depression Inventory (BDI-II) and MADRS, excluding suicidal ideation items.
Additional assessments include reports on treatment discontinuation, suicide attempts, side effects, withdrawal symptoms, neuropsychological tests, and 3T Magnetic Resonance Imaging measurements.
Step 5
Sample collection
Blood and stool samples are collected to create a biobank for future research.

Who can join the trial?

11 criteria

The patient is a man or a woman aged at least 18 years old and 65 years old at the most.
The patient is hospitalized.
The patient suffers from a current major depressive episode without psychotic features according to DSM-5 criteria and a Montgomery-Asberg Depression Rating Scale (MADRS) score greater than 20, as part of a bipolar or major depressive disorder.
- Major depressive episode: A period of at least two weeks where a person feels very sad or loses interest in most activities.
- Psychotic features: Symptoms like seeing or hearing things that are not there.
- DSM-5 criteria: A guide used by doctors to diagnose mental health conditions.
- Montgomery-Asberg Depression Rating Scale (MADRS): A tool used to measure the severity of depression.
- Bipolar disorder: A mental health condition with extreme mood swings.
- Major depressive disorder: A mental health condition with persistent feelings of sadness and loss of interest.
- The patient has a current Scale for Suicidal Ideation (SSI) score greater than 8.
  - Scale for Suicidal Ideation (SSI): A tool used to measure the severity of suicidal thoughts.
  - The patient must have given his/her informed and signed consent.
  - The patient must be insured or a beneficiary of a health insurance plan.

Who cannot join the trial?

3 criteria

Individuals with certain mental disorders cannot participate. Mental disorders are conditions that affect a person's thinking, feeling, mood, or behavior, such as depression or anxiety.
Participants must be within a specific age range, which is not specified here.
Both males and females are eligible, but certain vulnerable populations are not included. Vulnerable populations might include groups like pregnant women or people with severe health conditions.

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Centre Hospitalier Universitaire De Nimes
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Nimes, France

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Investigated drugs

Buprenorphine is being studied as an additional treatment for severe suicidal thoughts during a major depressive episode. The trial aims to determine if buprenorphine can effectively reduce suicidal ideas compared to a placebo. The study also seeks to find out which dosage of buprenorphine is more effective.

Buprenorphine

What is already known about the treatment

Buprenorphine – Buprenorphine is administered orally and is being studied for its potential to reduce severe suicidal thoughts in individuals experiencing a major depressive episode. It is currently under investigation in clinical trials, with a focus on its effectiveness compared to a placebo. The main therapeutic indication is for mental disorders, specifically targeting suicidal ideation. At the molecular level, buprenorphine acts as a partial agonist at the mu-opioid receptor, which may help modulate mood and reduce suicidal thoughts. It is classified pharmacologically as an opioid medication, typically used for pain relief and opioid addiction treatment, but is being explored for new therapeutic uses in mental health.

Investigated diseases

Mental Disorders – Mental disorders encompass a wide range of conditions that affect mood, thinking, and behavior. These disorders can manifest as depression, anxiety, bipolar disorder, schizophrenia, and more. Symptoms vary widely but may include persistent sadness, excessive worry, mood swings, or distorted thinking. The progression of mental disorders can be gradual or sudden, and symptoms may fluctuate over time. Factors such as genetics, environment, and lifestyle can influence the development and course of these disorders. Understanding and managing mental disorders often require a comprehensive approach, considering both psychological and physiological aspects.