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The Effects of Sertraline on Depression in Parkinson's Disease (PD; PDD)

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ClinicalTrials.gov Identifier: NCT01437189
Recruitment Status : Unknown
Verified August 2011 by Wei Luo, Zhejiang University.
Recruitment status was:  Recruiting
First Posted : September 20, 2011
Last Update Posted : September 20, 2011
Sponsor:
Information provided by (Responsible Party):
Wei Luo, Zhejiang University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Depression Parkinson's Disease Drug: Sertraline Not Applicable

Detailed Description:

Depression in PD is associated with more severe cognitive and functional impairments, a faster progression of illness, worse quality of life, increase mortality and higher burden for caregivers, when compare PD patients without depression. Depression accounts for approximately 40-50% in PD patients, which is also well known as a main factor impacting on health-related quality of life (HRQoL) in negative way in the context of PD and even their caregivers. In our previous cross-sectional study, the investigators have already studied the prevalence of depressive symptoms in PD patients and also have proved how depressive symptoms severely worsen HRQoL in PD patients in the area of the mainland China. In order to improve HRQoL of PD, some interventions, for example, taking some antidepressants to improve depression are urgently required. In addition, the investigators had already tested the validity and reliability of Chinese version of the 39-item Parkinson's disease questionnaire (PDQ-39) in mainland China, the paper about which already have been published in journal of Zhejiang university science B (biomedicine and biotechnology) already, therefore, the investigators can use the questionnaire of Chinese version of PDQ-39 to assess PD patients' quality of life.

Treatment of depression with antidepressant drugs is well established. In the last 20 years, the application of antidepressant has risen mainly due to the introduction of the selective serotonin reuptake inhibitors (SSRIs). These drugs are now the most commonly prescribed antidepressants in patients with depression in general. Regarding depression in the context of PD, a recent survey in the U.S. showed that 63% of the prescriptions for depression in PD were for SSRIs and only 7.5% for tricyclic antidepressants (TCAs). The preference of SSRIs over the older TCAs is supposedly based on their similar efficacy but better tolerability, especially when compared with tertiary amines, such as amitriptyline or imipramine. Sertraline is characterized by a low selectivity for serotonin relative to dopamine reuptake, suggesting a favorable efficacy profile. There was a randomized study pointing out that both sertraline and low-dose amitriptyline improved depressive symptoms in PD, and a significant benefit on quality of life was observed only with sertraline. Still, more studies are needed to demonstrate whether sertraline is effective to depression in PD patients. Further more, there is no trial about the efficacy and safety of sertraline on depression in PD in mainland China. It's necessary for us to initiate and conduct this trial in mainland China.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Protocol of Self-Controlled Study on the Effects of Sertraline on Depression in Parkinson's Disease
Study Start Date : August 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: Sertraline
    Starting 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.
    Other Name: Zoloft

Outcome Measures
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Primary Outcome Measures :
  1. change from baseline in Hamilton Depression Rating Scale [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. change from baseline in questionnaire of PDQ-39 [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437189


Contacts
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Contact: Wei Luo, PH.D&M.D 13757120109 luoweirock@yahoo.com.cn

Locations
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China, Zhejiang
Department of Neurology, the Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Wei Luo, PH.D&M.D    13757120109    luoweirock@yahoo.com.cn   
Sponsors and Collaborators
Zhejiang University
Investigators
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Principal Investigator: Wei Luo, PH.D&M.D School of medcine, Zhejiang University
More Information
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Responsible Party: Wei Luo, associate professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT01437189    
Other Study ID Numbers: WS1851055
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: August 2011
Keywords provided by Wei Luo, Zhejiang University:
Parkinson's disease
depression
sertraline
intervention
Additional relevant MeSH terms:
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Parkinson Disease
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
 Synucleinopathies
Neurodegenerative Diseases
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs