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

• ClinicalTrials.gov Identifier: NCT02917122
• Recruitment Status: Terminated
• First Posted: September 28, 2016
• Results First Posted: October 20, 2021
• Last Update Posted: October 20, 2021
• Sponsor: National Cheng-Kung University Hospital
• Information provided by (Responsible Party): Kao Chin, Chen, National Cheng-Kung University Hospital

Tracking Information

• First Submitted Date: June 30, 2016
• First Posted Date: September 28, 2016
• Results First Submitted Date: August 26, 2021
• Results First Posted Date: October 20, 2021
• Last Update Posted Date: October 20, 2021
• Study Start Date: August 2015
• Actual Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 22, 2021)

• Change of Modified-Unified Parkinson's Disease Rating Scale Among Different Weeks [ Time Frame: week 0 and 6 ]
  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 [ Time Frame: week 0 and 6 ]
  Hamilton Rating Scale for Depression: summed, 0-50 higher value is worse
• Change of Taiwanese Depression Questionnaire Among Different Weeks [ Time Frame: week 0 and 6 ]
  Taiwanese Depression Questionnaire: summed, 0-54 higher value is worse

Original Primary Outcome Measures (submitted: September 27, 2016)

• Change of Unified Parkinson's Disease Rating Scale among different weeks [ Time Frame: week -1, 0, 2, 4, and 6 ]
• Change of Hoehn and Yahr scale among different weeks [ Time Frame: week -1, 0, 2, 4, and 6 ]
• Change of Hamilton Rating Scale for Depression among different weeks [ Time Frame: week -1, 0, 2, 4, and 6 ]
• Change of Taiwanese Depression Questionnaire among different weeks [ Time Frame: week -1, 0, 2, 4, and 6 ]
• Change of Global Assessment of Functioning among different weeks [ Time Frame: week -1, 0, 2, 4, and 6 ]
• Change of clinical global impression among different weeks [ Time Frame: week -1, 0, 2, 4, and 6 ]

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: September 27, 2016)

• Change of finger tapping test among different weeks [ Time Frame: week 0 and 6 ]
• Change of continuous performance task among different weeks [ Time Frame: week 0 and 6 ]
• Change of Wisconsin Card Sorting Test among different weeks [ Time Frame: week 0 and 6 ]
• Change of Wechsler Memory Scale - Revised among different weeks [ Time Frame: week 0 and 6 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease
• Official Title: The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease
• 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.

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Parkinson Disease
• Depression

Intervention

• Device: 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.
• Drug: Sertraline
  Patients will take Sertraline.
• Device: 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.

Study Arms

• Placebo Comparator: sertraline + sham tDCS
  Patients will take sham tDCS.
  Interventions:

  • Drug: Sertraline
  • Device: sham tDCS
• Active Comparator: 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.
  Interventions:

  • Device: active tDCS
  • Drug: Sertraline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 22, 2021): 15
• Original Estimated Enrollment (submitted: September 27, 2016): 40
• Actual Study Completion Date: August 2021
• Actual Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02917122
• Other Study ID Numbers: A-BR-103-079
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Kao Chin, Chen, National Cheng-Kung University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: National Cheng-Kung University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Kao Chin Chen, PhD; National Cheng-Kung University Hospital

• PRS Account: National Cheng-Kung University Hospital
• Verification Date: September 2021