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The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease (Parkinson's)

Primary Purpose

Parkinson Disease, Depression

Status

Terminated

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

active tDCS

Sertraline

sham tDCS

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, transcranial direct current stimulation, depression, dopamine transporter, single photon emission computerized tomography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Suffers from Parkinson's disease fulfill the Parkinson's Disease Society Brain Bank clinical criteria with insidious 2 or more PD symptoms (bradykinesia, tremor, or rigidity).
Suffers from "DSM-IV major depressive disorder, single episode" or "DSM-IV major depressive disorder, recurrent" according to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) criteria.
Reported duration of the current episode is ≥4 weeks and has not been treated with antidepressants.
Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥20 at the screening (baseline) visit.
Is a man or woman aged 18 to 75 years, inclusive.

Exclusion criteria:

Subjects known to have allergies to sertraline and pimozide.
Subjects showed any signs of substantial risk of suicide during the trial.
Subjects ever received electroconvulsive treatment.
Subjects co-morbid with other major mental disorders or with substance/alcohol dependence or abuse in the past 6 months per DSM-IV criteria.
Nursing women, pregnant women or patients suspected pregnant.
History or presence of clinically significant hepatic, cardiovascular or renal disease, or other serious medical disease that might compromise the study.
History of seizure disorder or need to taking medications that increase the risk of seizure.
History or presence of dementia and any previous history of brain tumor, brain arteriovenous malformation, encephalitis or meningitis.
Subjects ever received or plan to receive brain surgery during the trial.
Subjects with pacemaker or are contraindicated for MRI.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

sertraline + sham tDCS

sertraline + active tDCS

Arm Description

Patients will take sham tDCS.

Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment.

Outcomes

Primary Outcome Measures

Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks

mds: modified-Unified Parkinson's Disease mds1 non-motor experiences of daily living: summed, 0-52 mds2 motor experiences of daily living: summed, 0-52 mds3 motor examination: summed, 0-132 mds4 motor complications: summed, 0-24 higher value is worse

Change of Hamilton Rating Scale for Depression Among Different Weeks

Hamilton Rating Scale for Depression: summed, 0-50 higher value is worse

Change of Taiwanese Depression Questionnaire Among Different Weeks

Taiwanese Depression Questionnaire: summed, 0-54 higher value is worse

Secondary Outcome Measures

Full Information

NCT ID

NCT02917122

First Posted

June 30, 2016

Last Updated

September 22, 2021

Sponsor

National Cheng-Kung University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02917122

Brief Title

The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease

Acronym

Parkinson's

Official Title

The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Terminated

Why Stopped

Funding is insufficient.

Study Start Date

August 2015 (undefined)

Primary Completion Date

August 2021 (Actual)

Study Completion Date

August 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cheng-Kung University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Parkinson's disease (PD) is one of the most common neurological diseases manifested by movement disturbance. The concomitant psychiatric symptoms, especially depression, are often observed and have also great impact on patients' quality of life. The treatment of depressive symptoms in PD with antidepressants as the majority remains variable and inefficient, which complicates the disease prognosis. Transcranial direct current stimulation (tDCS) is a non-invasive brain modulation technique and has been demonstrated to improve psychiatric diseases such as major depression. In this study the investigators will assess the combined effects of tDCS on sertraline for the treatment of depression in PD. Ten sessions of tDCS in two weeks will be applied and the follow-up evaluation will continue bi-weekly for one month after completing all sessions. The efficacy of tDCS vs sertraline will be compared and evaluated with behavioral and cognitive outcome. In addition, the investigators will evaluate if the baseline dopaminergic activity in brain could predict the treatment outcome by using SPECT imaging. The investigators aim to establish the therapeutic parameters and safety criteria of tDCS as an add-on or alternative therapy, and further enhance the overall clinical efficacy in the treatment of depression in PD.

Detailed Description

Study design This study is a factorial randomized, placebo-control trial, including 2 groups: 'sertraline only' (sertraline + sham tDCS), and 'combined treatment' (sertraline + active tDCS). It is planned to recruit 20 subjects for each group, which results in all together 40 participants. Patients will take 12 tDCS sessions (30min for each session): first 10 consecutive sessions for two weeks (Monday to Friday), and then 2 follow-up sessions scheduled 2 and 4 weeks after the consecutive treatment. Both pharmacological and tDCS intervention will be started simultaneously on the first day of the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Depression

Keywords

Parkinson disease, transcranial direct current stimulation, depression, dopamine transporter, single photon emission computerized tomography

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sertraline + sham tDCS

Arm Type

Placebo Comparator

Arm Description

Patients will take sham tDCS.

Arm Title

sertraline + active tDCS

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

active tDCS

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Sertraline

Intervention Description

Patients will take Sertraline.

Intervention Type

Device

Intervention Name(s)

sham tDCS

Intervention Description

Primary Outcome Measure Information:

Title

Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks

Description

Time Frame

week 0 and 6

Title

Change of Hamilton Rating Scale for Depression Among Different Weeks

Description

Hamilton Rating Scale for Depression: summed, 0-50 higher value is worse

Time Frame

week 0 and 6

Title

Change of Taiwanese Depression Questionnaire Among Different Weeks

Description

Taiwanese Depression Questionnaire: summed, 0-54 higher value is worse

Time Frame

week 0 and 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Suffers from Parkinson's disease fulfill the Parkinson's Disease Society Brain Bank clinical criteria with insidious 2 or more PD symptoms (bradykinesia, tremor, or rigidity). Suffers from "DSM-IV major depressive disorder, single episode" or "DSM-IV major depressive disorder, recurrent" according to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) criteria. Reported duration of the current episode is ≥4 weeks and has not been treated with antidepressants. Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥20 at the screening (baseline) visit. Is a man or woman aged 18 to 75 years, inclusive. Exclusion criteria: Subjects known to have allergies to sertraline and pimozide. Subjects showed any signs of substantial risk of suicide during the trial. Subjects ever received electroconvulsive treatment. Subjects co-morbid with other major mental disorders or with substance/alcohol dependence or abuse in the past 6 months per DSM-IV criteria. Nursing women, pregnant women or patients suspected pregnant. History or presence of clinically significant hepatic, cardiovascular or renal disease, or other serious medical disease that might compromise the study. History of seizure disorder or need to taking medications that increase the risk of seizure. History or presence of dementia and any previous history of brain tumor, brain arteriovenous malformation, encephalitis or meningitis. Subjects ever received or plan to receive brain surgery during the trial. Subjects with pacemaker or are contraindicated for MRI.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kao Chin Chen, PhD

Organizational Affiliation

National Cheng-Kung University Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease

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