Depression | The Effects of Sertraline on Depression in Parkinson's Disease
Depression research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. 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. 2. All patients should have a confirmed diagnosis of PD according to Brain Bank Criteria. 3. Diagnosed to be major depression episode according to DSM-IV, 4. Mini Mental State Examination (MMSE) exclude dementia. Exclusion Criteria: 1. Mini-Mental State Examination (MMSE) demonstrate dementia 2. Any current DSM-IV Axis I diagnosis other than a depressive or anxiety disorder. 3. History of psychosis or hallucinations or under treatment with atypical neuroleptics. 4. Treatment-resistant depression. Treatment-resistant depression (TRD) occurs when a patient with unipolar depression fails to respond to adequate antidepressant therapy. 5. Pregnancy or lactation. 6. Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs). 7. Concomitant use in patients taking pimozide.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:SertralineStarting dose 25mg/day for 1 week, then increasing to 50mg/day, add on 50mg each time when the depressive symptoms are not improved, at 2-week intervals. Maximum: 200mg/day. Maintenance: lowest effective dose.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: August 2011
Completed Date: March 2013
Primary Outcome: change from baseline in Hamilton Depression Rating Scale
Secondary Outcome: change from baseline in questionnaire of PDQ-39
Study sponsors, principal investigator, and references
Lead Sponsor: Zhejiang University