Study of Antidepressants in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00086190
• Date of registration: 28/06/2004
• Prospective Registration: Yes
• Primary sponsor: University of Rochester
• Public title: Study of Antidepressants in Parkinson's Disease SAD-PD
• Scientific title: Study of Antidepressants in Parkinson's Disease
• Date of first enrolment: June 2005
• Target sample size: 115
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00086190
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, Puerto Rico, United States

Contacts

• Name: William McDonald, MD
• Affiliation: Co-Principal Investigator--Emory University School of Medicine

• Name: Irene Richard, MD
• Affiliation: University of Rochester

Key inclusion & exclusion criteria

Inclusion Criteria:

To be eligible you must be:

- 30 years old or older

- diagnosed with Parkinson's disease

- experiencing symptoms of depression such as sadness, decreased energy, or problems
sleeping



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Depression

Parkinson Disease

Intervention(s)

Drug: venlafaxine

Other: placebo

Drug: paroxetine

Primary Outcome(s)

Change in Hamilton Depression Rating Scale (HAM-D) Scores [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Secondary Outcome(s)

Change in Geriatric Depression Rating Scale (GDS) [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Short Form 36 Health Survey - Mental Health [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Brief Psychiatric Rating Scale (BPRS) [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Short Form 36 Health Survey - Mental Component Summary [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Short Form 36 Health Survey - Role-Emotional [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Snaith Clinical Anxiety Scale (CAS) [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Beck Depression Inventory II (BDI-II) [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Short Form 36 Health Survey - Vitality [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Montgomery-Asberg Depression Rating Scale (MADRS) [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Unified Parkinson's Disease Rating Scale (UPDRS) [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Change in Pittsburgh Sleep Quality Index (PSQI) [Time Frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase]

Secondary ID(s)

R01NS046487

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurological Disorders and Stroke (NINDS)

Results

• Results available: Yes
• Date Posted: 04/01/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00086190