N/A
N=35
The Effects of Sertraline on Depression in Parkinson's Disease
Depression · Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01437189 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Change From Baseline in Hamilton Depression Rating Scale (HAMD) — 48.1; 35.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sertraline (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Zhejiang University
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hamilton Depression Rating Scale (HAMD) |
48.1; 35.5 | — |
| SECONDARY Change From Baseline in Questionnaire of PDQ-39, |
51; 46 | — |
Summary
The aim of this open-label, self-control study is to evaluate the efficacy of sertraline in treating depression in Patients with Parkinson's disease. In addition, the investigators also want to find out whether patient gets better quality of life when depression is improved.
Eligibility Criteria
Inclusion Criteria
- Patients between 35 and 75 years of age from the outpatients clinic in Department of Neurology, the Second Affiliated Hospital, School of Medicine, Zhejiang University.
- All patients should have a confirmed diagnosis of PD according to Brain Bank Criteria.
- Diagnosed to be major depression episode according to DSM-IV,
- Mini Mental State Examination (MMSE) exclude dementia.
Exclusion Criteria
- Mini-Mental State Examination (MMSE) demonstrate dementia
- Any current DSM-IV Axis I diagnosis other than a depressive or anxiety disorder.
- History of psychosis or hallucinations or under treatment with atypical neuroleptics.
- Treatment-resistant depression. Treatment-resistant depression (TRD) occurs when a patient with unipolar depression fails to respond to adequate antidepressant therapy.
- Pregnancy or lactation.
- Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs).
- Concomitant use in patients taking pimozide.
Data sourced from ClinicalTrials.gov (NCT01437189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.