Phase 3
N=115
Study of Antidepressants in Parkinson's Disease
Parkinson Disease · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00086190 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Change in Hamilton Depression Rating Scale (HAM-D) Scores — -13.0; -11.0; -6.8 Change in HAM-D score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- paroxetine (Drug); venlafaxine (Drug); placebo (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Depression Rating Scale (HAM-D) Scores |
-13.0; -11.0; -6.8 | — |
| SECONDARY Change in Montgomery-Asberg Depression Rating Scale (MADRS) |
-13.6; -10.9; -6.6 | — |
| SECONDARY Change in Beck Depression Inventory II (BDI-II) |
-9.7; -9.6; -5.2 | — |
| SECONDARY Change in Geriatric Depression Rating Scale (GDS) |
-6.9; -6.9; -2.8 | — |
| SECONDARY Change in Brief Psychiatric Rating Scale (BPRS) |
-9.0; -9.8; -4.4 | — |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) |
-8.7; -7.0; -4.3 | — |
| SECONDARY Change in Snaith Clinical Anxiety Scale (CAS) |
-3.6; -3.2; -2.4 | — |
| SECONDARY Change in Pittsburgh Sleep Quality Index (PSQI) |
-2.1; -2.6; -1.1 | — |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor |
-4.3; -2.0; -1.0 | — |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor |
0.4; 0.5; -0.6 | — |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar |
-1.4; -1.4; -0.5 | — |
| SECONDARY Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall |
-8.0; -8.4; -5.3 | — |
| SECONDARY Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being |
-21.4; -20.7; -10.9 | — |
| SECONDARY Change in Short Form 36 Health Survey - Mental Component Summary |
11.4; 9.5; 4.8 | — |
| SECONDARY Change in Short Form 36 Health Survey - Vitality |
13.5; 9.1; 4.7 | — |
| SECONDARY Change in Short Form 36 Health Survey - Role-Emotional |
39.5; 26.9; 12.7 | — |
| SECONDARY Change in Short Form 36 Health Survey - Mental Health |
16.7; 17.4; 9.7 | — |
Summary
The purpose of this study is to find out if two antidepressant medications, paroxetine and venlafaxine, can help control depression in Parkinson's disease, and if these medications affect the motor symptoms of Parkinson's disease such as tremor, stiffness, slowness, and balance.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00086190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.