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

NCT02917122 | Terminated Phase 1 Results DMC

• 1 other identifier: A-BR-103-079
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease; Depression

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  week 0 and 6

• Change of Hamilton Rating Scale for Depression Among Different Weeks

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

  week 0 and 6

• Change of Taiwanese Depression Questionnaire Among Different Weeks

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

  week 0 and 6

Study Arms (2)

sertraline + sham tDCS

PLACEBO COMPARATOR

Patients will take sham tDCS.

Drug: Sertraline; Device: sham tDCS

sertraline + active tDCS

ACTIVE COMPARATOR

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.

Device: active tDCS; Drug: Sertraline

Interventions

active tDCS 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

Sertraline DRUG

Patients will take Sertraline.

sertraline + active tDCS; sertraline + sham tDCS

sham tDCS 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 + sham tDCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

MeSH Terms

Conditions

Parkinson Disease; Depression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Kao Chin Chen
• Organization: National Cheng Kung University

andchen@mail.ncku.edu.tw

+886-6-2353535

Study Officials

• Kao Chin Chen, PhD

  National Cheng-Kung University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: September 28, 2016
• Study Start: August 1, 2015
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 20, 2021
• Results First Posted: October 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share