Trial · NCT00086190
Study of Antidepressants in Parkinson's Disease
NCT00086190, Phase 3, Completed, University of Rochester; results first posted 2013-01-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Antidepressants in Parkinson's Disease. Trials, record NCT00086190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00086190
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Antidepressants in Parkinson's Disease
- NCT number
- NCT00086190
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 115 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Parkinson Disease, Depression
- Interventions
- paroxetine, venlafaxine, placebo
- First posted
- 2004-06-29
- Last updated
- 2013-01-04
- Results first posted
- 2013-01-04
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Hamilton Depression Rating Scale (HAM-D) Scores | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23. |
| Secondary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression. |
| Secondary | Change in Beck Depression Inventory II (BDI-II) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | Beck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression. |
| Secondary | Change in Geriatric Depression Rating Scale (GDS) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression. |
| Secondary | Change in Brief Psychiatric Rating Scale (BPRS) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties. |
| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0. |
| Secondary | Change in Snaith Clinical Anxiety Scale (CAS) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety. |
| Secondary | Change in Pittsburgh Sleep Quality Index (PSQI) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties. |
| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms. |
| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Hamilton Depression Rating Scale (HAM-D) Scores | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Change in HAM-D score | MEAN |
| SECONDARY | Change in Montgomery-Asberg Depression Rating Scale (MADRS) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Change in MADRS score | MEAN |
| SECONDARY | Change in Beck Depression Inventory II (BDI-II) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Change in BDI-II score | MEAN |
| SECONDARY | Change in Geriatric Depression Rating Scale (GDS) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Change in GDS score | MEAN |
| SECONDARY | Change in Brief Psychiatric Rating Scale (BPRS) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Change in BPRS score | MEAN |
| SECONDARY | Change in Unified Parkinson's Disease Rating Scale (UPDRS) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Change in UPDRS score | MEAN |
| SECONDARY | Change in Snaith Clinical Anxiety Scale (CAS) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Change in CAS score | MEAN |
| SECONDARY | Change in Pittsburgh Sleep Quality Index (PSQI) | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Change in PQSI score | MEAN |
| SECONDARY | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Change in UPDRS-motor score | MEAN |
| SECONDARY | Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor | from the beginning (0 weeks) to end (12 weeks) of the double-blind phase | 115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle. | Change in UPDRS-tremor score | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Hamilton Depression Rating Scale (HAM-D) Scores | Paroxetine | -13.0 | Standard Deviation 1.3 | Change in HAM-D score | |
| Change in Hamilton Depression Rating Scale (HAM-D) Scores | Venlafaxine Extended Release | -11.0 | Standard Deviation 1.4 | Change in HAM-D score | |
| Change in Hamilton Depression Rating Scale (HAM-D) Scores | Placebo | -6.8 | Standard Deviation 1.3 | Change in HAM-D score | |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) | Paroxetine | -13.6 | Standard Error 1.2 | Change in MADRS score | |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) | Venlafaxine Extended Release | -10.9 | Standard Error 1.3 | Change in MADRS score | |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) | Placebo | -6.6 | Standard Error 1.2 | Change in MADRS score | |
| Change in Beck Depression Inventory II (BDI-II) | Paroxetine | -9.7 | Standard Error 1.1 | Change in BDI-II score | |
| Change in Beck Depression Inventory II (BDI-II) | Venlafaxine Extended Release | -9.6 | Standard Error 1.2 | Change in BDI-II score | |
| Change in Beck Depression Inventory II (BDI-II) | Placebo | -5.2 | Standard Error 1.1 | Change in BDI-II score | |
| Change in Geriatric Depression Rating Scale (GDS) | Paroxetine | -6.9 | Standard Error 1.0 | Change in GDS score |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paroxetine | 42 | |
| Overall Study | STARTED | Venlafaxine Extended Release | 34 | |
| Overall Study | STARTED | Placebo | 39 | |
| Overall Study | COMPLETED | Paroxetine | 34 | |
| Overall Study | COMPLETED | Venlafaxine Extended Release | 30 | |
| Overall Study | COMPLETED | Placebo | 33 | |
| Overall Study | NOT COMPLETED | Paroxetine | 8 | |
| Overall Study | NOT COMPLETED | Venlafaxine Extended Release | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events87
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Insomnia | Psychiatric disorders | Paroxetine | 1 | 42 | 1 |
| other | Insomnia | Psychiatric disorders | Venlafaxine Extended Release | 7 | 34 | 7 |
| other | Insomnia | Psychiatric disorders | Placebo | 9 | 39 | 9 |
| other | Abnormal Dreaming | Psychiatric disorders | Paroxetine | 1 | 42 | 1 |
| other | Abnormal Dreaming | Psychiatric disorders | Venlafaxine Extended Release | 1 | 34 | 1 |
| other | Abnormal Dreaming | Psychiatric disorders | Placebo | 4 | 39 | 4 |
| other | Somnolence | Psychiatric disorders | Paroxetine | 8 | 42 | 8 |
| other | Somnolence | Psychiatric disorders | Venlafaxine Extended Release | 8 | 34 | 8 |
| other | Somnolence | Psychiatric disorders | Placebo | 5 | 39 | 5 |
| other | Diaphoresis | Skin and subcutaneous tissue disorders | Paroxetine | 4 | 42 | 4 |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paroxetine | ||
| Total, all-cause mortality | Venlafaxine Extended Release | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Paroxetine | 10 | 42 |
| Total, other adverse events | Venlafaxine Extended Release | 8 | 34 |
| Total, other adverse events | Placebo | 9 | 39 |
| Total, serious adverse events | Paroxetine | 0 | 42 |
| Total, serious adverse events | Venlafaxine Extended Release | 0 | 34 |
| Total, serious adverse events | Placebo | 0 | 39 |
Source ClinicalTrials.gov
Papers34
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS046487 | Study of Antidepressants in Parkinson's Disease (SAD PD) | RICHARD, IRENE H | UNIVERSITY OF ROCHESTER | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2004 to 2008 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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