Parkinson DiseasePhase 2NCT06530290
Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients
A Phase 2 study testing Mirtazapine 15 MG in people with Parkinson Disease and Anxiety, run by Leila Dargahi. PharmD PhD at 1 site in Iran.
Trial summary
This study is a single-center, parallel and double-blind study in Movement Disorders Clinic of Shohadaye Tajrish Hospital. Patients, researchers (physicians, outcome assessors) and data analysts are blinded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Anxiety
- What is being tested?
- Mirtazapine 15 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteIran
- Study dates
- 1 Jun 2022to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital
Tehran
Mehri Salari, MDFelloship, +989124972186, mehri.salari@gmail.com
About this study
Official title: Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial
This study is a single-center, parallel and double-blind study in Movement Disorders Clinic of Shohadaye Tajrish Hospital. Patients, researchers (physicians, outcome assessors) and data analysts are blinded. After assessing the inclusion and exclusion criteria's, patients who assigned the informed consent form, are randomly divided into control and treatment groups.Patients in treatment or placebo groups respectively receive mirtazapine (15 mg) or placebo, once a day for 12 weeks. Primary (anxiety) and secondary (depression, fatigue, sleep disorders, and quality of life) outcomes are evaluated at baseline, and after 4 and 12 weeks of treatments.
- Conditions
- Parkinson Disease, Anxiety
- Being tested
- Mirtazapine 15 MG, Placebo
- Keywords
- Parkinson's disease, Anxiety, Mirtazapine
- Medical subject headings
- Parkinson Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirtazapine 15 MGDrug
Mirtazapine (15 mg), once a day for 12 weeks
PlaceboDrug
Placebo, once a day, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mirtazapine | Experimental | Mirtazapine (15 mg), once a day, for 12 weeks Receives: Drug: Mirtazapine 15 MG |
| Placebo | Placebo comparator | Placebo, once a day, for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety score
Anxiety score using Hamilton Anxiety Rating Scale (HAM-A)
Measured: Baseline, and after 4 and 12 weeks of treatment
Anxiety score
Parkinson Anxiety Scale (PAS) questionnaires
Measured: Baseline, and after 4 and 12 weeks of treatment
Secondary outcomes (4)
Depression score
Depression score using Hamilton Depression Rating Scale (HAM-D) questionnaire
Measured: Baseline, and after 4 and 12 weeks of treatment
Fatigue score
Fatigue score using Parkinson's Disease Fatigue Scale (PDFS) questionnaire
Measured: Baseline, and after 4 and 12 weeks of treatment
Sleep disorder score
Sleep disorder score using Parkinson's disease Sleep Scale (PDSS) questionnaire
Measured: Baseline, and after 4 and 12 weeks of treatment
Quality of life score
Quality of life score using Parkinson's Disease Quality of Life (PDQL) questionnaire
Measured: Baseline, and after 4 and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Jun 2022
- Primary completion20 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leila Dargahi. PharmD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leila Dargahi. PharmD PhD, Shahid Beheshti University of Medical Sciences
- Investigators
- Leila Dargahi, PharmD/PhD, Principal investigator, Shahid Beheshti University of Medical SciencesMehri Salari, MDFellowship, Principal investigator, Shahid Beheshti University of Medical SciencesNeda Valian, PhD, Study director, Shahid Beheshti University of Medical SciencesLeila Mohaghegh Shalmani, PharmD/PhD, Study chair, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530290
- Sponsor's protocol ID
- IR.SBMU.PHNS.REC.1400.130
- Status last verified
- Jul 2024
- First submitted
- 22 Apr 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06530290
- Acronym / sponsor ID
- IR.SBMU.PHNS.REC.1400.130
- Conditions
- Parkinson Disease, Anxiety
- Keywords
- Parkinson's disease, Anxiety, Mirtazapine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Leila Dargahi. PharmD PhDUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-center, parallel and double-blind study in Movement Disorders Clinic of Shohadaye Tajrish Hospital. Patients, researchers (physicians, outcome assessors) and data analysts are blinded. After assessing the inclusion and exclusion criteria's, patients who assigned the informed consent form, are randomly divided into control and treatment groups.Patients in treatment or placebo groups respectively receive mirtazapine (15 mg) or placebo, once a day for 12 weeks. Primary (anxiety) and secondary (depression, fatigue, sleep disorders, and quality of life) outcomes are evaluated at baseline, and after 4 and 12 weeks of treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirtazapine | Experimental | Drug: Mirtazapine 15 MGMirtazapine (15 mg), once a day, for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, once a day, for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirtazapine 15 MGMirtazapine (15 mg), once a day for 12 weeks | Drug | Mirtazapine |
| PlaceboPlacebo, once a day, for 12 weeks | Drug | Placebo |
Primary outcome
Anxiety score
Time frame: Baseline, and after 4 and 12 weeks of treatment
Anxiety score using Hamilton Anxiety Rating Scale (HAM-A)
Anxiety score
Time frame: Baseline, and after 4 and 12 weeks of treatment
Parkinson Anxiety Scale (PAS) questionnaires
4 secondary outcomes
Depression score
Time frame: Baseline, and after 4 and 12 weeks of treatment
Fatigue score
Time frame: Baseline, and after 4 and 12 weeks of treatment
Sleep disorder score
Time frame: Baseline, and after 4 and 12 weeks of treatment
Quality of life score
Time frame: Baseline, and after 4 and 12 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leila Dargahi, PharmD/PhD principal investigator
Shahid Beheshti University of Medical Sciences
Mehri Salari, MDFellowship principal investigator
Shahid Beheshti University of Medical Sciences
Neda Valian, PhD study director
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirtazapine 15 MG in people with Parkinson Disease and Anxiety, run by Leila Dargahi. PharmD PhD at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leila Dargahi, PharmD/PhD (+989125069930, l.dargahi@sbmu.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety score (time frame: Baseline, and after 4 and 12 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.