DepressionPDNCT01437189
The Effects of Sertraline on Depression in Parkinson's Disease
A study testing Sertraline in people with Depression and Parkinson's Disease, run by Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Depression, Parkinson's Disease
- What is being tested?
- Sertraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2011to 1 Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, the Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: Clinical Protocol of Self-Controlled Study on the Effects of Sertraline on Depression in Parkinson's Disease
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.
Read the 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.
- Conditions
- Depression, Parkinson's Disease
- Being tested
- Sertraline
- Keywords
- Parkinson's disease, depression, sertraline, intervention
- Medical subject headings
- Depression, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
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.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients with depression | Experimental | It is a self-controlled study only contains one arm, aims to investigate the effects of Sertraline on depression in Parkinson's disease Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: baseline, 8 weeks (endpoint)
Secondary outcomes (1)
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.
Measured: Baseline, 8 weeks (endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study start1 Aug 2011
- Primary completion1 Aug 2013
- Study completion1 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Luo, Zhejiang University
- Investigators
- Wei Luo, PH.D&M.D, Principal investigator, School of medcine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437189
- Sponsor's protocol ID
- WS1851055
- Acronym
- PD
- Status last verified
- Jan 2024
- First submitted
- 16 Sep 2011
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Marino S, Sessa E, Di Lorenzo G, Digangi G, Alagna A, Bramanti P, Di Bella P. Sertraline in the treatment of depressive disorders in patients with Parkinson's disease. Neurol Sci. 2008 Dec;29(6):391-5. doi: 10.1007/s10072-008-1021-3. Epub 2008 Nov 11.
PubMed 19002650
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Protocol of Self-Controlled Study on the Effects of Sertraline on Depression in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01437189
- Acronym / sponsor ID
- PD / WS1851055
- Conditions
- Depression, Parkinson's Disease
- Keywords
- Parkinson's disease, depression, sertraline, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 1 Aug 2013 (actual)
- Study completion
- 1 Nov 2013 (actual)
- First posted
- 20 Sep 2011 (estimated)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients with depression | Experimental | Drug: SertralineIt is a self-controlled study only contains one arm, aims to investigate the effects of Sertraline on depression in Parkinson's disease |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| SertralineAlso: ZoloftStarting 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. | Drug | Parkinson's disease patients with depression |
Primary outcome
Change From Baseline in Hamilton Depression Rating Scale (HAMD)
Time frame: 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%).
1 secondary outcome
Change From Baseline in Questionnaire of PDQ-39,
Time frame: Baseline, 8 weeks (endpoint)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19002650Marino S, Sessa E, Di Lorenzo G, Digangi G, Alagna A, Bramanti P, Di Bella P. Sertraline in the treatment of depressive disorders in patients with Parkinson's disease. Neurol Sci. 2008 Dec;29(6):391-5. doi: 10.1007/s10072-008-1021-3. Epub 2008 Nov 11.
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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.
Wei Luo, PH.D&M.D principal investigator
School of medcine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sertraline in people with Depression and Parkinson's Disease, run by Zhejiang University at 1 site in China.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jan 2024. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hamilton Depression Rating Scale (HAMD) (time frame: baseline, 8 weeks (endpoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01437189, which also lists 1 linked publication.
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 30 Jan 2024.