Depression, Parkinson's Disease
Conditions
Keywords
Parkinson's disease, depression, sertraline, intervention
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.
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.
Interventions
DRUGSertraline
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.
Sponsors
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hamilton Depression Rating Scale (HAMD) | baseline, 8 weeks (endpoint) | The minimum and maximum value of HAMD is 0 and 96 respectively. The higher score means worse severity of depression. Combined with reducing scores rate of HAMD, there are four grades: heal (HAMD is lower than 8 or reducing rate is higher than 75%), excellent utility (reducing rate is between 50% and 75%), utility (reducing rate is between 25% and 50%) and nullity (reducing rate is lower than 25%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Questionnaire of PDQ-39, | Baseline, 8 weeks (endpoint) | The minimum and maximum value of PDQ-39 is 0 and 116respectively. The higher score means worse severity of quality of life. |
Countries
China
Participant flow
Recruitment details
Start on August/01 2011 Location: the second affiliated hospital of Zhejiang University, School of medicine.
Participants by arm
| Arm | Count |
|---|---|
| Parkinson's Disease Patients With Depression 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. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Parkinson's Disease Patients With Depression |
|---|---|
| Age, Continuous | 60 years |
| Region of Enrollment China | 35 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 3 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Change From Baseline in Hamilton Depression Rating Scale (HAMD)
The minimum and maximum value of HAMD is 0 and 96 respectively. The higher score means worse severity of depression. Combined with reducing scores rate of HAMD, there are four grades: heal (HAMD is lower than 8 or reducing rate is higher than 75%), excellent utility (reducing rate is between 50% and 75%), utility (reducing rate is between 25% and 50%) and nullity (reducing rate is lower than 25%).
Time frame: baseline, 8 weeks (endpoint)
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Parkinson's Disease Patients With Depression | Change From Baseline in Hamilton Depression Rating Scale (HAMD) | baseline | 48.1 score on a scale | Standard Error 7.4 |
| Parkinson's Disease Patients With Depression | Change From Baseline in Hamilton Depression Rating Scale (HAMD) | endpoint | 35.5 score on a scale | Standard Error 10.5 |
Secondary
Change From Baseline in Questionnaire of PDQ-39,
The minimum and maximum value of PDQ-39 is 0 and 116respectively. The higher score means worse severity of quality of life.
Time frame: Baseline, 8 weeks (endpoint)
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Parkinson's Disease Patients With Depression | Change From Baseline in Questionnaire of PDQ-39, | baseline | 51 units on a scale | Standard Deviation 10.5 |
| Parkinson's Disease Patients With Depression | Change From Baseline in Questionnaire of PDQ-39, | endpoint | 46 units on a scale | Standard Deviation 9.7 |