About this trial
This study evaluates the use of an oral multi-strain probiotic in the treatment of depression in individuals with Parkinson's Disease. Participants will be randomized to either a 12-week multi-strain probiotic treatment or placebo intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria
Between the ages of 40-80 years
Mild to Moderate PD (Hoehn and Yahr stage between 1-3 in the "ON" state)
Mild to moderate depression (BDI-II score of 14-28 in the "ON" state)
Disqualifiers
Atypical Parkinsonism
Active suicidality
Active psychosis
Cognitive score (MoCA) of < 21 in the "ON" state
Trial design
Parallel
Treatments tested in this trial
Probiotic
Dietary supplementOral probiotic delivered in powdered form.
Placebo
Dietary supplementOral placebo delivered in powdered form.
Treatment groups
Trial outcomes
Primary outcomes
Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C)
The Inventory for Depressive Symptomatology is a measure of depressive signs and symptoms administered by a trained clinician. The score range is 0-84 points, with a higher score indicating greater levels of depressive symptomatology.
Beck Depression Inventory, 2nd Edition (BDI-II)
The Beck Depression Inventory is a self-reported 21-question multiple-choice self-report inventory on a scale from 0-63. A higher score indicates greater characteristic attitudes and symptoms of depression. BDI-II is also used as a screening item for mild to moderate depression for this study.
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
QIDS-SR is a 16-item, self-administered questionnaire used to assess the severity of depressive symptoms over the past 7 days, based on DSM-IV criteria. QIDS-SR is a shortened version of IDS-C, but QIDS-SR is self-rated (filled in the form of a questionnaire) and IDS-C is clinician-rated (administered as a clinical assessment), so using both assessments allows us to incorporate both self-rated and clinician-rated measures. The score range is 0-27 points, with a higher score indicating greater levels of depressive symptomatology.
Secondary outcomes
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale is a self-reported 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders on a scale from 1 (strongly disagree) to 7 (strongly agree). The minimum score is 9 and the maximum score is 63. A higher score indicates greater fatigue severity.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment test is a one-page, 30-point assessment administered by trained individuals that is used for detecting mild cognitive impairment and dementia. Score may range from 0-30 points and a lower score may indicate greater cognitive impairment.
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The Movement Disorder Society Unified Parkinson's Disease Rating Scale is a clinical assessment of motor and non-motor symptoms in individuals with Parkinson's Disease (PD). It consists of four subscales. Subscales 1, 3, and 4 are administered by a trained individual and subscale 2 is self-reported. Each item is rated from 0 to 4. The total score can range from 0-199, with a higher score indicating greater impairment in PD.
Parkinson's Anxiety Scale (PAS)
The Parkinson's Anxiety Scale is a 12-point observer or patient-rated scale that has three subscales: persistent anxiety, episodic anxiety, and avoidance behaviour. It is rated using a Likert scale (0-4). Possible scores range from 0-48, with a higher score indicating greater severity of anxiety symptoms.
Sponsors and contacts
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