PAX-D: study protocol for a randomised placebo-controlled trial evaluating the efficacy and mechanism of pramipexole as add-on treatment for people with treatment resistant depression Skip to main contentLog In Basket Search Latest content Topic collection Archive Authors About JobsYou are hereHome Archive Volume 25, Issue 2Email alertsArticleTextArticleinfoCitationToolsShareRapid ResponsesArticlemetricsAlertsPDFProtocolPAX-D: study protocol for a randomised placebo-controlled trial evaluating the efficacy and mechanism of pramipexole as add-on treatment for people with treatment resistant depression http://orcid.org/0000-0002-0516-4755Sheena Kristine Au-Yeung1, James Griffiths1, Sophie Roberts1, Chloe Edwards1, Ly-Mee Yu2, Rafal Bogacz3, Jennifer Rendell1,4, http://orcid.org/0000-0002-1248-8248Mary-Jane
A good sleep would be dop(aminergic) doc! Pramipexole in restless legs syndrome October 19, 2020 A good sleep would be dop(aminergic) doc! Pramipexole in restless legs syndrome Clinical Question: Is pramipexole effective for the treatment of restless legs syndrome (RLS)? Bottom Line: Systematic review of twelve randomized controlled trials demonstrates 63 % of patients using pramipexole report feeling much or very much better compared to 41% on placebo over 3-26 weeks. Lower doses (example 0.25/0.5mg) may have equivalent efficacy to higher doses with less risk of augmentation (paradoxical worsening of symptoms with treatment), although up to ~40% of patients may experience augmentation after 1 year. Evidence: • Systematic review 12 randomized, controlled
A Randomized Phase 3 Study Comparing P2B001 to its Components (Low-Dose Extended-Release Rasagiline and Pramipexole) and to Optimized Doses of Marketed Extended-Release Pramipexole in Early Parkinson's Disease. There remains uncertainty as to the optimal way to initiate therapy for Parkinson's disease (PD) to maximize benefit and minimize adversity. The objective was to determine if P2B001 (a fixed, low-dose, extended-release [ER] combination of pramipexole 0.6 mg and rasagiline 0.75 mg) is superior to each of its components and compare its safety and efficacy to optimized treatment with marketed doses of pramipexole-ER. This was a 12-week, double-blind study (NCT03329508). Total of 544 untreated patients with PD were randomized (2:2:2:1) to treatment with P2B001, its individual components
Pramipexole improves depression-like behavior in diabetes mellitus with depression rats by inhibiting NLRP3 inflammasome-mediated neuroinflammation and preventing impaired neuroplasticity. Diabetes mellitus (DM) is frequently associated with the occurrence and development of depression, and the co-occurrence of diabetes mellitus with depression (DD) may further reduce patients' quality of life . Recent research indicates that dopamine receptors (DRs) play a crucial role in immune and metabolic regulation. Pramipexole (PPX), a D2/3R agonist, has demonstrated promising neuroprotective and immunomodulatory effects. Nevertheless, the therapeutic effects and mechanisms of action of PPX on DM-induced depression are not clear at present. Depression, DM, and DD were induced in a rat model through
The effects of pramipexole on motivational vigour during a saccade task: a placebo-controlled study in healthy adults. Motivation allows us to energise actions when we expect reward and is reduced in depression. This effect, termed motivational vigour, has been proposed to rely on central dopamine, with dopaminergic agents showing promise in the treatment of depression. This suggests that dopaminergic agents might act to reduce depression by increasing the effects of reward or by helping energise actions. The aim of the current study was to investigate whether the dopamine agonist pramipexole enhanced motivational vigour during a rewarded saccade task. In addition, we asked whether the effects of pramipexole on vigour differ between reward contingent on performance and guaranteed reward
A novel opioid/pramipexole combination treatment for the management of acute pain: a pilot study. Despite their dangerous side effects, opioid drugs remain a standard of care for moderate to severe pain with few alternatives. Strategies to maintain the analgesic effects of opioids while minimizing the associated risks are needed. Pre-clinical studies have shown using a dopamine 3 receptor (D3R to the emergency department, from which patients were randomized to either the "control" or "study arm". The control group received standard treatment of care (morphine, 0.1 mg/kg; i.v.) and an oral placebo pill. The experimental group received half-dosed morphine and oral pramipexole pill (0.25 mg). Pain measurements including a numerical pain scale and visual analog scale were collected from enrollees
Pramipexole Enhances Reward Learning by Preserving Value Estimates. Dopamine D2-like agonists show promise as treatments for depression. They are thought to act by enhancing reward learning, however the mechanisms by which they achieve this is not clear. Reinforcement-learning accounts describe three distinct candidate mechanisms; increased reward sensitivity, increased inverse decision -temperature and decreased value-decay. As these mechanisms produce equivalent effects on behaviour, arbitrating between them requires measurement of how expectations and prediction errors are altered. We characterized the effects of 2-weeks of the D2-like agonist pramipexole on reward learning and used fMRI measures of expectation and prediction error to assess which of these three mechanistic processes
Pramipexole modulates fronto-subthalamic pathway in sequential working memory. Brain dopamine may regulate the ability to maintain and manipulate sequential information online. However, the precise role of dopamine remains unclear. This pharmacological fMRI study examined whether and how the dopamine D2/3 receptor agonist pramipexole modulates fronto-subthalamic or fronto-striatal pathways during sequential working memory. This study used a double-blind, randomized crossover design. Twenty-two healthy male volunteers completed a digit ordering task during fMRI scanning after receiving a single oral dose of 0.5-mg pramipexole or placebo. The pramipexole effects on task performance, regional activity, activity pattern similarity, and functional connectivity were analyzed. Pramipexole impaired task
Comparative Pharmacokinetics and Bioequivalence Evaluation of Two Formulations of Pramipexole Dihydrochloride Extended-Release Tablets in Healthy Chinese Subjects Under Fasted and Fed States: A Randomized, Open-Label, Single-Dose, Two-Period Crossover Cl Pramipexole dihydrochloride extended-release tablet is a novel long-acting form of non-ergot dopamine agonist indicated as one of main therapeutic approaches for Parkinson's disease. However, pharmacokinetic properties of extended-release pramipexole in healthy Chinese subjects remain unclear. A single-center, randomized, open-label, two-period crossover, single-dose study was performed to investigate comparative pharmacokinetics and evaluate bioequivalence of 0.375 mg test (Yangtze River Pharmaceutical Group Co., Ltd.) and reference
Add-on pramipexole for anhedonic depression: study protocol for a randomised controlled trial and open-label follow-up in Lund, Sweden. Many depressed patients do not achieve remission with available treatments. Anhedonia is a common residual symptom associated with treatment resistance as well as low function and quality of life. There are currently no specific and effective treatments for anhedonia. Some trials have shown that dopamine agonist pramipexole is efficacious for treating depression, but more data is needed before it could become ready for clinical prime time. Given its mechanism of action, pramipexole might be a useful treatment for a depression subtype characterised by significant anhedonia and lack of motivation-symptoms associated with dopaminergic hypofunction. We recently
Effect of Zishen pingchan granules combined with pramipexole on serum BDNF, IL-1β, IL-6, CRP, TNF-α levels in depressed patients with Parkinson's disease: Results of a randomized, double-blind, controlled study. Depression is a common comorbidity in Parkinson's Disease (PD) and treatment of depression can significantly support PD management. Zishen pingchan granules (ZPG), a traditional Chinese . Eighty PD patients treated with pramipexole but still experiencing mild to moderate depression symptoms were randomly allocated to a group receiving 12-week ZPG treatment (n = 40) or placebo (n = 40). The Hamilton Depression Scale 17 items (HAM-D-17) was utilized to evaluate changes in depressive symptoms from baseline over 12 weeks, while the Unified Parkinson's Disease Rating Scales (UPDRS) part 3
PAX-D: study protocol for a randomised placebo-controlled trial evaluating the efficacy and mechanism of pramipexole as add-on treatment for people with treatment resistant depression. Clinical depression is usually treated in primary care with psychological therapies and antidepressant medication. However, when patients do not respond to at least two or more antidepressants within a depressive episode, they are considered to have treatment resistant depression (TRD). Previous small randomised controlled trials suggested that pramipexole, a dopamine D2/3 receptor agonist, may be effective for treating patients with unipolar and bipolar depression as it is known to influence motivational drive and reward processing. PAX-D will compare the effects of pramipexole vs placebo when added to current
Comparison of pramipexole and citalopram in the treatment of depression in Parkinson's disease: A randomized parallel-group trial. Depression is one of the most common neuropsychiatric symptoms in Parkinson's disease (PD). There is little evidence to guide depression treatment in these patients. The aim of this study was to compare citalopram and pramipexole in reducing depressive symptoms in patients with PD. In the present 8-week randomized trial, we compared the efficacy of pramipexole versus citalopram in the treatment of depression in PD patients. For this purpose, 44 PD patients with depression randomly received open-label oral citalopram tablets or pramipexole and their depression, quality of life, and daytime sleepiness scores were evaluated at baseline and after the 8-week trial
Enhanced Taste Recognition Following Subacute Treatment With The Dopamine D2/D3 Receptor Agonist Pramipexole in Healthy Volunteers. Patients with Parkinson's disease (PD) show impaired performance in taste recognition tests, which suggests a possible dopaminergic influence on gustatory functioning. To experimentally test this hypothesis, we assessed whether pharmacological manipulation of dopaminergic signaling in healthy volunteers can affect performance in a standardized taste recognition test. Physically and mentally healthy volunteers (n = 40, age 18-43 years) were randomly allocated to treatment with either pramipexole or placebo using a double-blind, parallel-group design. After 12 to 15 days of treatment (dose titrated up from 0.25 mg/d of pramipexole salt to 1.0 mg/d), taste
Add-On Pramipexole for the Treatment of Schizophrenia and Schizoaffective Disorder: A Randomized Controlled Trial. Several small clinical trials have reported that the dopamine agonist pramipexole was beneficial in treating patients with schizophrenia. A confirmatory trial was conducted to test this hypothesis. This 16-week, multicenter, double-blind, randomized, placebo-controlled study included 200 subjects meeting criteria for schizophrenia or schizoaffective disorder. Patients were randomized to receive either pramipexole (0.75 mg twice daily, n = 100) or placebo (n = 100) as an add-on to their regular antipsychotic treatment. The primary outcome measure was the total score on the Positive and Negative Syndrome Scale (PANSS); secondary outcome measures included PANSS subscale
Zishen pingchan granules combined with pramipexole in the improvement of depressive symptoms in Parkinson's disease: a prospective, multicenter, randomized, double-blind, controlled clinical study. Zishen Pingchan granule (ZPG), a traditional Chinese herbal recipe for treating Parkinson's disease (PD), is usually used as an add-on drug with some antiparkinsonian drugs in China. The objectives of this study were to evaluate the efficacy, safety, and tolerability of ZPG combined with pramipexole in the treatment of depression in PD (dPD). A 12-week, multicenter, randomized, double-blind, and placebo-controlled study on ZPG was performed on a total of 200 patients who were treated with pramipexole but still had mild to moderate depressive symptoms. Patients were randomly divided into ZPG (n = 100
Effects of Pramipexole Combined with Nerve Growth Factor on Cognitive Impairment and Urinary AD7c-NTP Expression in Patients with Parkinson's Disease. To explore the effects of pramipexole combined with nerve growth factor (NGF) on cognitive impairment and urinary Alzheimer-associated neural thread protein (AD7c-NTP) expression in patients with Parkinson's disease (PD). Fifty patients with PD treated in our hospital from February 2020 to April 2021 were enrolled. The patients were arbitrarily assigned into control group and study group. The former was treated with pramipexole, and the latter was treated with pramipexole combined with NGF. The efficacy, cognitive function, serum inflammatory factors, cortisol levels, serum macrophage migration inhibitory factor (MIF), brain-derived
Comparative Analysis of the Effects of Escitalopram, Pramipexole, and Transcranial Magnetic Stimulation on Depression in Patients With Parkinson Disease: An Open-Label Randomized Controlled Trial. This study aimed to compare the effects of different antidepressant therapies on depression in patients with Parkinson disease (PD) and to provide a reference for clinical treatment. A total of 328 into the experimental group. The subjects were randomly divided into 4 groups, and 118 were eventually completed: routine treatment group (n = 29), routine treatment + escitalopram group (n = 29), routine treatment + pramipexole group (n = 31), and routine treatment + transcranial magnetic stimulation (TMS) group (n = 29). After 4 weeks of treatments, the efficacy of each treatment was evaluated using HAMD score
Comparison of pramipexole versus ropinirole in the treatment of Parkinson's disease. Parkinson's disease is a progressive neurodegenerative disease characterized by motor and non-motor symptoms. Levodopa is the most effective drug in the symptomatic treatment of the disease. Dopamine receptor agonists provide sustained dopamin-ergic stimulation and have been found to delay the initiation of levodopa treatment and reduce the frequency of various motor complications due to the long-term use of levodopa. The primary aim of this study was to compare the efficacy of potent nonergoline dopamine agonists pramipexole and ropinirole in both "dopamine agonist monotherapy group" and "levodopa add-on therapy group" in Parkinson's disease. The secondary aims were to evaluate the effects of these agents
An Experimental Medicine Investigation of the Effects of Subacute Pramipexole Treatment on Emotional Information Processing in Healthy Volunteers. Treatment with the dopamine D2/D3 receptor agonist pramipexole has demonstrated promising clinical effects in patients with depression. However, the mechanisms through which pramipexole might alleviate depressive symptoms are currently not well understood. Conventional antidepressant drugs are thought to work by biasing the processing of emotional information in favour of positive relative to negative appraisal. In this study, we used an established experimental medicine assay to explore whether pramipexole treatment might have a similar effect. Employing a double-blind, parallel-group design, 40 healthy volunteers (aged 18 to 43 years, 50