Study on Pramipexole for Reducing Anhedonia in Patients with Major Depression

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What is this study about?

This clinical trial is focused on studying the effects of the medication Pramipexole on symptoms of anhedonia in individuals with major depression. Anhedonia is a condition where a person finds it difficult to feel pleasure in activities they usually enjoy. The study aims to determine if treatment with Pramipexole can reduce these symptoms over a nine-week period when compared to a placebo. Pramipexole is administered in the form of a prolonged-release tablet, which means it releases the medication slowly over time to maintain a steady level in the body.

Participants in the study will receive either Pramipexole or a placebo and will be monitored over the course of nine weeks. The maximum dosage of Pramipexole will be 3.15 milligrams per day, adjusted to avoid any intolerable side effects. The study will involve regular assessments to track changes in anhedonia symptoms and other related measures. These assessments will include questionnaires and possibly the use of activity meters to measure physical activity and sleep patterns. Additionally, some participants may undergo brain imaging techniques like fMRI to observe brain activity related to pleasure and reward.

The purpose of this study is to explore whether Pramipexole can be an effective additional treatment for reducing anhedonia in people with major depression. By comparing the effects of Pramipexole to a placebo, researchers hope to gain insights into its potential benefits and any side effects. The study is expected to continue until December 2026, with the goal of improving treatment options for those experiencing anhedonia as part of their depression.

1 initial assessment

Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes reviewing your medical history and current medications.

You will be asked to complete the Snaith-Hamilton Pleasure Scale (SHAPS-C) to evaluate symptoms of anhedonia, which is a reduced ability to experience pleasure.

2 baseline measurements

Baseline measurements will be taken, including the SHAPS-C score, to establish a starting point for the study.

Additional assessments may include physical activity monitoring, sleep analysis, and neuropsychological tests.

3 medication administration

You will be randomly assigned to receive either pramipexole or a placebo. Pramipexole is taken orally, with the dosage gradually increased to a maximum of 3.15 mg, depending on tolerance.

The medication will be administered over a period of nine weeks.

4 follow-up assessments

Follow-up assessments will occur at weeks 3, 6, and 9. These will include repeating the SHAPS-C and other evaluations to monitor changes in symptoms and overall health.

You may also be asked to participate in additional tests, such as brain imaging and blood tests, to gather more data on the effects of the treatment.

5 final evaluation

At the end of the nine-week period, a final evaluation will be conducted to assess the overall impact of the treatment.

This will include a comprehensive review of all collected data and a discussion of your experience during the trial.

Who Can Join the Study?

Age between 18 and 75 years.
Diagnosis of unipolar depressive episode, bipolar disorder in depressive phase, or dysthymia (a persistent mild depression).
Experiencing anhedonia symptoms, which means having little or no pleasure in activities that are usually enjoyable. This is measured by scoring 3 or 4 points on at least 3 items of the Snaith-Hamilton Pleasure Scale (SHAPS-C).
Currently taking at least one antidepressant or mood stabilizing medication for at least 4 weeks.
Has tried an antidepressant at a therapeutic dose but has not achieved remission, which means the depression has not fully gone away (refractory stage 1 depression).
Has given informed consent to participate in the study, meaning they understand the study and agree to take part.

Who Cannot Join the Study?

Patients with any other serious mental health conditions besides major depression cannot participate.
Patients who have had a recent heart attack or have severe heart disease are not eligible.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with severe liver or kidney disease are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently using certain medications that might interfere with the study treatment are not eligible.
Patients with a history of allergic reactions to similar medications are excluded.
Patients who have participated in another clinical trial within the last 30 days cannot join.
Patients with a history of substance abuse or addiction within the past year are not eligible.
Patients who are unable to comply with the study procedures or follow-up visits are excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Skane	Malmo	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.02.2023

Trial locations

Investigated drugs:

Pramipexole

Pramipexole is a medication being studied for its potential to help with symptoms of anhedonia, which is a condition where people find it hard to feel pleasure in activities they usually enjoy. In this clinical trial, researchers are looking at whether taking Pramipexole can reduce these symptoms in people with depression. The goal is to see if this medication can make a difference over a nine-week period. Pramipexole works by affecting certain chemicals in the brain that are linked to mood and motivation, and the study aims to find out if it can help improve these feelings without causing too many side effects.

Major Depressive Disorder – Major Depressive Disorder is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It often involves changes in sleep, appetite, and energy levels, leading to difficulties in daily functioning. The disorder can cause cognitive impairments, such as trouble concentrating or making decisions. Emotional symptoms may include feelings of worthlessness or excessive guilt. Physical symptoms can manifest as aches, pains, or digestive problems without a clear physical cause. The progression of the disorder varies, with symptoms potentially lasting for weeks, months, or longer if untreated.

Trial ID:

2024-512495-35-00

NCT ID:

NCT05355337

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Pramipexole for Reducing Anhedonia in Patients with Major Depression

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