In short
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for persistent depressive disorder. This trial is examining the long-term use of pramipexole as an add-on therapy specifically for patients experiencing anhedonia, the inability to feel pleasure in activities that were once enjoyable. The study is taking place in Sweden and builds on previous short-term research to evaluate the medication's effectiveness and safety over an extended period.
Clinical trial locations
Study on the Long-term Use of Pramipexole for Patients with Anhedonic Depression
This clinical trial is investigating pramipexole, a medication that works by stimulating dopamine receptors in the brain, as a long-term add-on treatment for people experiencing anhedonic depression. Anhedonia is a particularly challenging symptom of depression where individuals lose the ability to feel pleasure or interest in activities they once enjoyed.
Main inclusion criteria:
- Adults between 18 and 65 years of age, both male and female
- Previous participation in a specific short-term research study comparing pramipexole to placebo (study number EudraCT# 2022-001563-26)
- For those who received pramipexole in the previous study: willingness to continue treatment
- For those who received placebo in the previous study: presence of anhedonia symptoms as measured by the Snaith-Hamilton Pleasure Scale, with scores of 3 or 4 on at least 3 items
- Provision of informed consent, meaning participants understand the study and agree to take part
Main exclusion criteria:
- Other serious medical conditions that might interfere with the study
- Current participation in another clinical trial
- Known allergy or sensitivity to pramipexole
- Pregnancy or breastfeeding
- History of substance abuse or addiction
- Major depressive episode within the last month
- History of bipolar disorder or schizophrenia
- Neurological disorders such as Parkinson's disease
- Use of medications that might interfere with pramipexole
- Inability to comply with study procedures
Study focus and goals:
The primary goal of this study is to evaluate how effective and well-tolerated pramipexole is when used over a long period as an additional treatment for anhedonic depression. The trial will last for a maximum of 25 weeks and will monitor various aspects of participants' health and well-being, including overall mood, physical activity levels, sleep patterns, and any side effects that may occur. Participants will take pramipexole in prolonged-release tablet form, which releases the medication slowly over time.
Throughout the study, researchers will collect comprehensive data through regular follow-up visits, questionnaires, physical activity monitoring, and possibly wearable devices. Participants may also undergo neuropsychological testing and provide biological samples. The study aims to gather detailed information to better understand how pramipexole can help improve symptoms of anhedonic depression and to ensure it is a safe and effective treatment option for long-term use.
Investigational drug:
Pramipexole is the medication being tested in this trial. It is classified as a dopamine agonist, which means it works by stimulating dopamine receptors in the brain. This action can help improve mood and motivation in people with depression. In this study, pramipexole is being used as an add-on treatment, meaning it is given in addition to participants' existing treatment plans to see if it provides additional benefit in managing symptoms of anhedonia.
Summary
Currently, there is only one active clinical trial for persistent depressive disorder, specifically targeting patients with anhedonia. This trial is notable for being a follow-up study that examines long-term treatment outcomes, building on previous short-term research. The study is located in Sweden and focuses exclusively on pramipexole as an add-on therapy.
The concentration of research on pramipexole reflects growing interest in dopamine-based approaches for treating specific symptoms of depression, particularly anhedonia, which can be resistant to traditional antidepressant treatments. The trial's design, which includes participants from both active treatment and placebo groups from a previous study, allows researchers to gather valuable data on sustained effectiveness and safety over an extended period.
