NCT01437189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
10.3 years until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

September 16, 2011

Results QC Date

March 24, 2022

Last Update Submit

January 25, 2024

Conditions

DepressionParkinson's Disease

Keywords

Parkinson's diseasedepressionsertralineintervention

Outcome Measures

Primary Outcomes (1)

  • 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%).

    baseline, 8 weeks (endpoint)

Secondary Outcomes (1)

  • Change From Baseline in Questionnaire of PDQ-39,

    Baseline, 8 weeks (endpoint)

Study Arms (1)

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

Drug: Sertraline

Interventions

SertralineDRUG

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.

Also known as: Zoloft
Parkinson's disease patients with depression

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, the Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

  • 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.

    PMID: 19002650BACKGROUND

MeSH Terms

Conditions

DepressionParkinson Disease

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Bo Wang
Organization
ZhejiangU
wangke1121@163.com
87784711

Study Officials

  • Wei Luo, PH.D&M.D

    School of medcine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 16, 2011

First Posted

September 20, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2013

Study Completion

November 1, 2013

Last Updated

January 30, 2024

Results First Posted

January 30, 2024

Record last verified: 2024-01

Locations

CN(1)