---
title: Reduce anxiety symptoms with mirtazapine
nct_id: NCT06530290
phase: PHASE2
status: RECRUITING
sponsor: Leila Dargahi. PharmD PhD
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06530290"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06530290"
last_fetched: "2026-05-10T14:07:26.916Z"
source: "Parkinson's Pathways (curated)"
---
# Reduce anxiety symptoms with mirtazapine

**Goal (in five words):** Reduce anxiety symptoms with mirtazapine

**Official Title:** Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial

**Trial ID:** [NCT06530290](https://clinicaltrials.gov/study/NCT06530290)

## Key Facts

- **Phase:** PHASE2
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Leila Dargahi. PharmD PhD
- **Target Enrollment:** 64 participants
- **Start Date:** 2022-06-01
- **Completion Date:** 2025-12-20
- **Conditions:** Parkinson Disease, Anxiety
- **Interventions:** Mirtazapine 15 MG, Placebo
- **Intervention Types:** DRUG

## Summary For Families

They're testing whether mirtazapine can reduce anxiety in people with Parkinson's, a common symptom that can seriously affect daily life. Mirtazapine is an antidepressant that boosts serotonin and norepinephrine signaling by blocking alpha-2 receptors and certain serotonin receptors, which can ease anxiety and often helps sleep and appetite; it is being compared to placebo. It does not replace levodopa, and while it has no major direct interaction with levodopa, it can cause sedation or low blood pressure so the trial asks for stable Parkinson's medications. The study is enrolling adults 18 and older with mild to moderate Parkinson's (Hoehn and Yahr 1,3) who have anxiety, excluding people with deep brain stimulation, recent antidepressant or MAOI use, major depression, unstable PD meds, serious heart/liver/kidney disease, pregnancy, or recent substance abuse.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

* Men and women over 17 years old
* Patient with Parkinson's disease according to UKPDSBB criteria
* Patient with mild/moderate Parkinson's disease according to Hoehn and Yahr Scale (HY score = 1-3)
* Self-report or clinical diagnosis of anxiety
* Patients who have signed informed consent to participate in the study.

Exclusion Criteria:

* Pregnant and lactating women
* Parkinson's patients with onset of disease in less than 1 year
* Unstable medication for Parkinson's disease during the last two weeks
* Parkinson's patients with DBS
* Patients with other neurodegenerative diseases like multiple system atrophy (MSA), Huntington's and etc.
* Patients with major depressive disorder
* A history of using SSRIs, SNRIs, benzodiazepines and β-blockers during the last 4 weeks
* A history of using MAO inhibitors
* A history of alcohol and substance abuse
* A history of acute stress during the last 3 months
* A history of suicide
* A history of cardiovascular diseases
* A history of liver and or kidney disorders
```

## Locations (1)

- Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital, Tehran, Iran _(35.6944, 51.4215)_
  - Mehri Salari, MDFelloship — (CONTACT) — +989124972186 — mehri.salari@gmail.com

## Central Contacts

- Leila Dargahi, PharmD/PhD — (CONTACT) — +989125069930 — l.dargahi@sbmu.ac.ir

---

*Canonical: https://parkinsonspathways.com/trial/NCT06530290*  
*HTML version: https://parkinsonspathways.com/trial/NCT06530290*  
*Source data: https://clinicaltrials.gov/study/NCT06530290*