Evaluating the effects of vortioxetine on depression in Parkinson's disease

Tolerability, Safety and Efficacy of Vortioxetine for Treatment od Depression in Parkinson's Disease: a 16 Week Open Label Study

This study is testing if vortioxetine can safely help people with Parkinson's disease who are dealing with depression feel better.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 30 Years to 80 Years
• Sex: All
• Sponsor: IRCCS San Raffaele Roma (Academic / other)
• Locations: 2 sites (Roma and 1 other locations)
• Trial ID: NCT04301492 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety, tolerability, and efficacy of vortioxetine, a multimodal antidepressant, in treating sustained depression in patients with Parkinson's disease. The study aims to assess treatment emergent adverse events, vital signs, and the non-worsening of motor disability through the Unified Parkinson's Disease Rating Scale. Participants will undergo various assessments, including laboratory tests and neurological examinations, to evaluate the impact of vortioxetine on their depressive symptoms and overall health.

Who should consider this trial

Good fit: Ideal candidates include adults aged 30 to 80 with a diagnosis of Parkinson's disease and sustained depression.

Not a fit: Patients with atypical Parkinsonism or those at risk of suicide may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing depression in Parkinson's disease without worsening motor symptoms.

How similar studies have performed: While the approach of using vortioxetine is relatively novel in this context, other studies have shown promise in treating depression with multimodal antidepressants.

Eligibility criteria

Inclusion Criteria:

* • Male and female of every ethnic group, age 30 to 80 years

  * Diagnosis of Parkinson's disease according UK Brain Bank Criteria
  * Hoehn \&Yahr: stage 1 to 3
  * Patients with diagnosis of sustained depression
  * Hamilton Depression Rating Scale score (HAM-D-17) ≥ 14
  * Beck Depression Inventory score (BDI)≥13
  * Stable doses of antiparkinsonian drugs for at least 4 weeks.
  * Patients able to understand and provide written informed consent
  * Female patients in post-menopausal state with at least one year absence of vaginal bleeding or spotting or be surgically sterile
  * Women of childbearing potential must use an acceptable method of contraception
  * Men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study

Exclusion Criteria:

* • Atypical Parkinsonism.

  * Subjects at risk of suicide (with a score ≥ 3 at the Item 3 of the HAM-D-17)
  * Any significant psychiatric, metabolic and systemic significant concomitant disease
  * Patients with clinically significant out of range laboratory values
  * Patients with history of epileptic seizures
  * Subjects with Dopa Dysregulation Syndrome (DDS)
  * Subjects treated with irreversible IMAO and IMAO-A
  * Use of vortioxetine in the past 30 days
  * Patient treated with oral anticoagulant
  * Patients participating in a clinical trial in the last 6 weeks
  * Patients with moderate-severe cognitive decline not able to provide consent form
  * Patients currently lactating or pregnant or planning to become pregnant during the duration of the study

Where this trial is running

Roma and 1 other locations

• IRCCS San Raffaele — Roma, Italy (Recruiting)
• IRCCS San Raffaele Roma — Rome, Italy (Recruiting)

Study contacts

• Study coordinator: fabrizio stocchi, MD PhD

Conditions Depression; vortioxetine; tolerability; safety; parkinson's disease