Not recruiting

Study on the Long-term Use of Pramipexole for Patients with Anhedonic Depression

Registered drug

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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 pramipexole in individuals with depression, specifically targeting those who experience a lack of pleasure or interest in activities, known as anhedonia. Pramipexole is a medication that comes in the form of a prolonged-release tablet, which means it is designed to release the active ingredient slowly over time when taken orally. The purpose of this study is to explore how effective and tolerable pramipexole is when used over a long period as an additional treatment for anhedonic depression.

Participants in this study will have previously taken part in a related research study that compared the short-term effects of pramipexole with a placebo. Those who were initially given pramipexole and wish to continue their treatment, as well as those who received a placebo and meet certain criteria, can join this follow-up study. The study will last for a maximum of 25 weeks, during which participants will continue to take pramipexole and be monitored for its effects on their symptoms of depression.

Throughout the study, various aspects of the participants' health and well-being will be assessed, including their overall mood, physical activity levels, sleep patterns, and any side effects they may experience. The study aims to gather comprehensive data to better understand how pramipexole can help improve symptoms of anhedonic depression and to ensure that it is a safe and effective treatment option for long-term use.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, confirm previous participation in the randomized controlled trial (RCT) testing the short-term efficacy of pramipexole versus placebo.
Ensure informed consent is provided to participate in this follow-up study.
Step 2
Initial assessment
Undergo an initial assessment to confirm eligibility, especially if previously assigned to the placebo group. This includes evaluating symptoms of anhedonia using the Snaith-Hamilton Pleasure Scale (SHAPS-C).
Step 3
Medication administration
Begin taking pramipexole orally as an add-on treatment for depression. The specific dosage and frequency will be determined by the study team based on individual needs and previous treatment response.
Step 4
Regular monitoring
Attend regular follow-up visits to monitor the efficacy and tolerability of the treatment. This includes tracking changes in SHAPS-C scores and other health indicators.
Participate in assessments that may include questionnaires and physical activity monitoring.
Step 5
Data collection
Provide data on various health metrics such as sleep patterns, physical activity, and mood through questionnaires and possibly wearable devices.
Undergo neuropsychological testing and provide biological samples if required.
Step 6
Completion
Upon completion of the study, a final assessment will be conducted to evaluate the overall impact of the treatment.
Receive information on the study's findings and any potential next steps regarding your treatment.

Who can join the trial?

7 criteria

Must have previously participated in a research study testing the short-term effects of **pramipexole** (a medication) compared to a **placebo** (a substance with no active medication) with the study number EudraCT# 2022-001563-26.
If you were in the group that received **pramipexole** in the previous study and want to continue treatment, you can join this study.
If you were in the group that received a **placebo** in the previous study and meet the requirements, you can join this study.
You must have given your **informed consent**, which means you understand the study and agree to participate.
If you received a **placebo** in the previous study, you must have symptoms of **anhedonia** (difficulty feeling pleasure) as measured by a specific scale, with scores of 3 or 4 on at least 3 items of the Snaith-Hamilton Pleasure Scale (SHAPS-C).
Open to both **male** and **female** participants.
Participants should be within the age range of **18 to 65 years**.

Who cannot join the trial?

10 criteria

Patients with any other serious medical condition that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have a known allergy or sensitivity to the study medication, pramipexole.
Patients who are pregnant or breastfeeding.
Patients with a history of substance abuse or addiction.
Patients who have had a major depressive episode within the last month.
Patients with a history of bipolar disorder or schizophrenia.
Patients who are unable to comply with the study procedures.
Patients who have been diagnosed with a neurological disorder, such as Parkinson's disease.
Patients who are taking medications that might interfere with the study drug.

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Investigated drugs

Pramipexole is a medication that is being studied for its potential benefits in treating anhedonic depression, which is a type of depression where people find it hard to feel pleasure in everyday activities. In this clinical trial, pramipexole is used as an additional treatment, meaning it is added to the patient's current treatment plan to see if it can help improve their symptoms over a long period. The study aims to find out how effective and well-tolerated pramipexole is when used for a long time in people with this type of depression.

Pramipexole

What is already known about the treatment

Pramipexole – Pramipexole is administered orally in tablet form and is currently being studied for its effectiveness and safety as an additional treatment for depression, specifically targeting symptoms of anhedonia, which is the inability to feel pleasure. In medical literature, it is recognized for its potential benefits in treating depression when used alongside other medications. The main therapeutic indication for pramipexole in this context is to alleviate symptoms of depression. At the molecular level, pramipexole works by stimulating dopamine receptors in the brain, which can help improve mood and motivation. It is classified pharmacologically as a dopamine agonist.

Investigated diseases

Depression – Depression is a mental health disorder characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can affect a person's thoughts, behavior, feelings, and sense of well-being. The progression of depression can vary, with symptoms ranging from mild to severe. Over time, individuals may experience changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. Emotional symptoms can include feelings of worthlessness or excessive guilt. Depression can also lead to physical symptoms such as aches and pains without a clear physical cause.