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

NCT ID: NCT02917122

Last Updated: 2021-10-20

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sertraline + sham tDCS

Patients will take sham tDCS.

Group Type PLACEBO_COMPARATOR

Sertraline

Intervention Type DRUG

Patients will take Sertraline.

sham tDCS

Intervention Type DEVICE

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.

sertraline + active 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.

Group Type ACTIVE_COMPARATOR

active tDCS

Intervention Type DEVICE

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.

Sertraline

Intervention Type DRUG

Patients will take Sertraline.

Interventions

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active 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.

Intervention Type DEVICE

Sertraline

Patients will take Sertraline.

Intervention Type DRUG

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
2. 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.
3. 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).
4. 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.
5. Reported duration of the current episode is ≥4 weeks and has not been treated with antidepressants.
6. Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥20 at the screening (baseline) visit.
7. Is a man or woman aged 18 to 75 years, inclusive.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kao Chin, Chen

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kao Chin Chen, PhD

Role: STUDY_CHAIR

National Cheng-Kung University Hospital

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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A-BR-103-079

Identifier Type: -

Identifier Source: org_study_id