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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2016
• Main ID: NCT02917122
• Date of registration: 30/06/2016
• Prospective Registration: No
• Primary sponsor: National Cheng-Kung University Hospital
• Public title: The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease Parkinson's
• Scientific title: The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease
• Date of first enrolment: August 2015
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02917122
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Contacts

• Name: Kao Chin Chen, PhD
• Affiliation: National Cheng-Kung University Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson Disease

Depression

Intervention(s)

Drug: Sertraline

Device: active tDCS

Device: sham tDCS

Primary Outcome(s)

Change of Hamilton Rating Scale for Depression 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 Taiwanese Depression Questionnaire 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 clinical global impression among different weeks [Time Frame: week -1, 0, 2, 4, and 6]

Change of Unified Parkinson's Disease Rating Scale among different weeks [Time Frame: week -1, 0, 2, 4, and 6]

Secondary Outcome(s)

Change of Wechsler Memory Scale - Revised 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 continuous performance task among different weeks [Time Frame: week 0 and 6]

Change of finger tapping test among different weeks [Time Frame: week 0 and 6]

Secondary ID(s)

A-BR-103-079

Source(s) of Monetary Support

Please refer to primary and secondary sponsors