Parkinson DiseasePhase 3SAD-PDNCT00086190
Study of Antidepressants in Parkinson's Disease
A Phase 3 study testing paroxetine and venlafaxine in people with Parkinson Disease and Depression, run by University of Rochester at 18 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease, Depression
- What is being tested?
- paroxetine and venlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Jun 2005to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States15 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21218
University of Maryland
Baltimore, Maryland, 21250
Beth Israel Deaconess Medical Center, Dept. of Neurology E/KS 430, 330 Brookline Avenue
Boston, Massachusetts, 02215
University of Virginia
Charlottesville, Virginia, 22901
University of Florida
Gainesville, Florida, 32610
Baylor College of Medicine, 6550 Fannin, Suite 1801
Houston, Texas, 77030
University of Kentucky
Lexington, Kentucky, 40536
University of Tennessee-Memphis
Memphis, Tennessee, 38163
University of Miami
Miami, Florida, 33136
Oregon Health Sciences University
Portland, Oregon, 97239
University of Rochester
Rochester, New York, 14627
University of California San Francisco
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
Medical University of Ohio
Toledo, Ohio
Canada2 sites
London Health Sciences Centre, University Campus Room A10-325, 339 Windermere Road
London, Ontario, N6A 5A5
Hotel-Dieu Hospital-CHUM
Montreal, Quebec, H2W 1T8
About this study
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.
Read the detailed description
Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression-a condition that causes disability and can reduce quality of life. The University of Rochester Medical Center is conducting a research study of antidepressant medications to find out more about how to treat depression in PD. Antidepressant medications have not been adequately studied in persons with PD.
The purpose of this study is to find out if the antidepressant medications paroxetine and venlafaxine can help control depression in PD and whether or not these medications affect the motor symptoms of PD such as tremor, stiffness, slowness, and balance.
This is a randomized, double blind, placebo-controlled, 12-week study of paroxetine immediate release (Paxil) and venlafaxine extended release (Effexor XR). Paroxetine and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine and venlafaxine XR have been shown to be effective in treating depression in the general population. Two hundred, twenty-eight persons will be enrolled among 15 medical centers throughout the United States and Canada. Each person will participate in the trial for 12 weeks. Each participant will be randomly assigned to take either paroxetine or venlafaxine, or a placebo.
- Conditions
- Parkinson Disease, Depression
- Being tested
- paroxetine, venlafaxine, placebo
- Keywords
- Parkinson disease, depression, Parkinson's disease, paroxetine, venlafaxine, antidepressant
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paroxetineDrug
Also called Paxil
Paroxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg.
venlafaxineDrug
Also called Effexor XR
Venlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg.
placeboOther
an inactive substance
| Study group | Role | What they receive |
|---|---|---|
| paroxetine | Active comparator | Paroxetine and venlafaxine will be compared to placebo over 12 weeks. Receives: Drug: paroxetine |
| venlafaxine extended release | Active comparator | Paroxetine and venlafaxine will be compared to placebo over 12 weeks. Receives: Drug: venlafaxine |
| placebo | Placebo comparator | Paroxetine and venlafaxine will be compared to placebo over 12 weeks. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Rating Scale (HAM-D) Scores
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.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Secondary outcomes (16)
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
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.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Beck Depression Inventory II (BDI-II)
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.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Geriatric Depression Rating Scale (GDS)
Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Brief Psychiatric Rating Scale (BPRS)
Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
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.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Snaith Clinical Anxiety Scale (CAS)
Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor
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.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor
Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar
Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall
Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.
Measured: 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
Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Mental Component Summary
Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Vitality
Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Role-Emotional
Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Change in Short Form 36 Health Survey - Mental Health
Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.
Measured: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2004 (estimated)
- Study startJun 2005
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Richard, University of Rochester
- Investigators
- Irene Richard, MD, Principal investigator, University of RochesterWilliam McDonald, MD, Principal investigator, Co-Principal Investigator--Emory University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086190
- Sponsor's protocol ID
- R01NS046487
- Acronym
- SAD-PD
- Status last verified
- Jan 2013
- First submitted
- 28 Jun 2004
- Last updated
- 4 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dooneief G, Mirabello E, Bell K, Marder K, Stern Y, Mayeux R. An estimate of the incidence of depression in idiopathic Parkinson's disease. Arch Neurol. 1992 Mar;49(3):305-7. doi: 10.1001/archneur.1992.00530270125028.
PubMed 1536634Liu CY, Wang SJ, Fuh JL, Lin CH, Yang YY, Liu HC. The correlation of depression with functional activity in Parkinson's disease. J Neurol. 1997 Aug;244(8):493-8. doi: 10.1007/s004150050131.
PubMed 9309555Kuopio AM, Marttila RJ, Helenius H, Toivonen M, Rinne UK. The quality of life in Parkinson's disease. Mov Disord. 2000 Mar;15(2):216-23. doi: 10.1002/1531-8257(200003)15:23.0.co;2-#.
PubMed 10752569Phillips P. Keeping depression at bay helps patients with Parkinson disease. JAMA. 1999 Sep 22-29;282(12):1118-9. No abstract available.
PubMed 10501101Global Parkinson's Disease Survey (GPDS) Steering Committee.. Factors impacting on quality of life in Parkinson's disease: results from an international survey. Mov Disord. 2002 Jan;17(1):60-7. doi: 10.1002/mds.10010.
PubMed 11835440Menza M, Dobkin RD, Marin H, Mark MH, Gara M, Buyske S, Bienfait K, Dicke A. A controlled trial of antidepressants in patients with Parkinson disease and depression. Neurology. 2009 Mar 10;72(10):886-92. doi: 10.1212/01.wnl.0000336340.89821.b3. Epub 2008 Dec 17.
PubMed 19092112Devos D, Dujardin K, Poirot I, Moreau C, Cottencin O, Thomas P, Destee A, Bordet R, Defebvre L. Comparison of desipramine and citalopram treatments for depression in Parkinson's disease: a double-blind, randomized, placebo-controlled study. Mov Disord. 2008 Apr 30;23(6):850-7. doi: 10.1002/mds.21966.
PubMed 18311826Yeragani VK, Roose S, Mallavarapu M, Radhakrishna RK, Pesce V. Major depression with ischemic heart disease: effects of paroxetine and nortriptyline on measures of nonlinearity and chaos of heart rate. Neuropsychobiology. 2002;46(3):125-35. doi: 10.1159/000066390.
PubMed 12422059Yeragani VK, Pesce V, Jayaraman A, Roose S. Major depression with ischemic heart disease: effects of paroxetine and nortriptyline on long-term heart rate variability measures. Biol Psychiatry. 2002 Sep 1;52(5):418-29. doi: 10.1016/s0006-3223(02)01394-x.
PubMed 12242058Nelson JC, Kennedy JS, Pollock BG, Laghrissi-Thode F, Narayan M, Nobler MS, Robin DW, Gergel I, McCafferty J, Roose S. Treatment of major depression with nortriptyline and paroxetine in patients with ischemic heart disease. Am J Psychiatry. 1999 Jul;156(7):1024-8. doi: 10.1176/ajp.156.7.1024.
PubMed 10401446Simons JA. Fluoxetine in Parkinson's disease. Mov Disord. 1996 Sep;11(5):581-2. doi: 10.1002/mds.870110517. No abstract available.
PubMed 8866503Steur EN. Increase of Parkinson disability after fluoxetine medication. Neurology. 1993 Jan;43(1):211-3. doi: 10.1212/wnl.43.1_part_1.211.
PubMed 8423889Jimenez-Jimenez FJ, Tejeiro J, Martinez-Junquera G, Cabrera-Valdivia F, Alarcon J, Garcia-Albea E. Parkinsonism exacerbated by paroxetine. Neurology. 1994 Dec;44(12):2406. doi: 10.1212/wnl.44.12.2406. No abstract available.
PubMed 7991139Salzman C. Pharmacologic treatment of depression in the elderly. J Clin Psychiatry. 1993 Feb;54 Suppl:23-8.
PubMed 8444831Altamura AC, De Novellis F, Guercetti G, Invernizzi G, Percudani M, Montgomery SA. Fluoxetine compared with amitriptyline in elderly depression: a controlled clinical trial. Int J Clin Pharmacol Res. 1989;9(6):391-6.
PubMed 2699465
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Antidepressants in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00086190
- Acronym / sponsor ID
- SAD-PD / R01NS046487
- Conditions
- Parkinson Disease, Depression
- Keywords
- Parkinson disease, depression, Parkinson's disease, paroxetine, venlafaxine, antidepressant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 29 Jun 2004 (estimated)
- Results
- Posted 4 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nearly 50 percent of individuals with Parkinson's disease (PD) suffer from depression-a condition that causes disability and can reduce quality of life. The University of Rochester Medical Center is conducting a research study of antidepressant medications to find out more about how to treat depression in PD. Antidepressant medications have not been adequately studied in persons with PD.
The purpose of this study is to find out if the antidepressant medications paroxetine and venlafaxine can help control depression in PD and whether or not these medications affect the motor symptoms of PD such as tremor, stiffness, slowness, and balance.
This is a randomized, double blind, placebo-controlled, 12-week study of paroxetine immediate release (Paxil) and venlafaxine extended release (Effexor XR). Paroxetine and venlafaxine XR are drugs that have been approved by the Food and Drug Administration (FDA) and are available by prescription. Paroxetine and venlafaxine XR have been shown to be effective in treating depression in the general population. Two hundred, twenty-eight persons will be enrolled among 15 medical centers throughout the United States and Canada. Each person will participate in the trial for 12 weeks. Each participant will be randomly assigned to take either paroxetine or venlafaxine, or a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| paroxetine | Active comparator | Drug: paroxetineParoxetine and venlafaxine will be compared to placebo over 12 weeks. |
| venlafaxine extended release | Active comparator | Drug: venlafaxineParoxetine and venlafaxine will be compared to placebo over 12 weeks. |
| placebo | Placebo comparator | Other: placeboParoxetine and venlafaxine will be compared to placebo over 12 weeks. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 30 years old or older
- diagnosed with Parkinson's disease
- experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paroxetineAlso: PaxilParoxetine 10 mg tablets or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the paroxetine or matching placebo will be increased to 20 mg, followed by a 10 mg increase every two weeks (if tolerated). Dosage for this study will not exceed 40 mg. | Drug | paroxetine |
| venlafaxineAlso: Effexor XRVenlafaxine XR 37.5 mg capsules or matching placebo given once a day for the first two weeks. If depression is not being effectively treated then the venlafaxine XR capsules or matching placebo will be increased to 75 mg followed by 75 mg increments every 2 weeks (if tolerated). Dosage for this study will not exceed 225 mg. | Drug | venlafaxine extended release |
| placeboan inactive substance | Other | placebo |
Primary outcome
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
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.
16 secondary outcomes
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 Beck Depression Inventory II (BDI-II)
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
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 Brief Psychiatric Rating Scale (BPRS)
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 Snaith Clinical Anxiety Scale (CAS)
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
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 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 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 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 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 Short Form 36 Health Survey - Vitality
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 Short Form 36 Health Survey - Mental Health
Time frame: from the beginning (0 weeks) to end (12 weeks) of the double-blind phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1536634Dooneief G, Mirabello E, Bell K, Marder K, Stern Y, Mayeux R. An estimate of the incidence of depression in idiopathic Parkinson's disease. Arch Neurol. 1992 Mar;49(3):305-7. doi: 10.1001/archneur.1992.00530270125028.
- Background: PubMed 9309555Liu CY, Wang SJ, Fuh JL, Lin CH, Yang YY, Liu HC. The correlation of depression with functional activity in Parkinson's disease. J Neurol. 1997 Aug;244(8):493-8. doi: 10.1007/s004150050131.
- Background: PubMed 10752569Kuopio AM, Marttila RJ, Helenius H, Toivonen M, Rinne UK. The quality of life in Parkinson's disease. Mov Disord. 2000 Mar;15(2):216-23. doi: 10.1002/1531-8257(200003)15:23.0.co;2-#.
- Background: PubMed 10501101Phillips P. Keeping depression at bay helps patients with Parkinson disease. JAMA. 1999 Sep 22-29;282(12):1118-9. No abstract available.
- Background: PubMed 11835440Global Parkinson's Disease Survey (GPDS) Steering Committee.. Factors impacting on quality of life in Parkinson's disease: results from an international survey. Mov Disord. 2002 Jan;17(1):60-7. doi: 10.1002/mds.10010.
- Background: PubMed 19092112Menza M, Dobkin RD, Marin H, Mark MH, Gara M, Buyske S, Bienfait K, Dicke A. A controlled trial of antidepressants in patients with Parkinson disease and depression. Neurology. 2009 Mar 10;72(10):886-92. doi: 10.1212/01.wnl.0000336340.89821.b3. Epub 2008 Dec 17.
- Background: PubMed 18311826Devos D, Dujardin K, Poirot I, Moreau C, Cottencin O, Thomas P, Destee A, Bordet R, Defebvre L. Comparison of desipramine and citalopram treatments for depression in Parkinson's disease: a double-blind, randomized, placebo-controlled study. Mov Disord. 2008 Apr 30;23(6):850-7. doi: 10.1002/mds.21966.
- Background: PubMed 12422059Yeragani VK, Roose S, Mallavarapu M, Radhakrishna RK, Pesce V. Major depression with ischemic heart disease: effects of paroxetine and nortriptyline on measures of nonlinearity and chaos of heart rate. Neuropsychobiology. 2002;46(3):125-35. doi: 10.1159/000066390.
- Background: PubMed 12242058Yeragani VK, Pesce V, Jayaraman A, Roose S. Major depression with ischemic heart disease: effects of paroxetine and nortriptyline on long-term heart rate variability measures. Biol Psychiatry. 2002 Sep 1;52(5):418-29. doi: 10.1016/s0006-3223(02)01394-x.
- Background: PubMed 10401446Nelson JC, Kennedy JS, Pollock BG, Laghrissi-Thode F, Narayan M, Nobler MS, Robin DW, Gergel I, McCafferty J, Roose S. Treatment of major depression with nortriptyline and paroxetine in patients with ischemic heart disease. Am J Psychiatry. 1999 Jul;156(7):1024-8. doi: 10.1176/ajp.156.7.1024.
- Background: PubMed 8866503Simons JA. Fluoxetine in Parkinson's disease. Mov Disord. 1996 Sep;11(5):581-2. doi: 10.1002/mds.870110517. No abstract available.
- Background: PubMed 8423889Steur EN. Increase of Parkinson disability after fluoxetine medication. Neurology. 1993 Jan;43(1):211-3. doi: 10.1212/wnl.43.1_part_1.211.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Richard, MD principal investigator
University of Rochester
William McDonald, MD principal investigator
Co-Principal Investigator--Emory University School of Medicine
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paroxetine and venlafaxine in people with Parkinson Disease and Depression, run by University of Rochester at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00086190, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.