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Study of Antidepressants in Parkinson's Disease (SAD-PD)

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ClinicalTrials.gov Identifier: NCT00086190
Recruitment Status : Completed
First Posted : June 29, 2004
Results First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Irene Richard, University of Rochester

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Parkinson Disease
Depression
Interventions: Drug: paroxetine
Drug: venlafaxine
Other: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
SAD-PD enrolled 115 participants from 20 centers in the US, Canada, and Puerto Rico from June 2005 through March 2009. Participants were recruited from movement disorder clinics. Eligible participants included men and women 30 years and older who were diagnosed with idiopathic PD, without dementia and who met depression criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Paroxetine Optimal paroxetine dosage was determined on a per patient basis. The mean dosage at week 12 was 24 +/- 11 mg/day.
Venlafaxine Extended Release Optimal venlafaxine extended release dosage was determined on a per patient basis. The mean dosage at week 12 was 121 +/- 75 mg/day.
Placebo Placebo was made to match treatment options.

Participant Flow:   Overall Study
    Paroxetine   Venlafaxine Extended Release   Placebo
STARTED   42   34   39 
COMPLETED   34   30   33 
NOT COMPLETED   8   4   6 
Adverse Event                6                2                2 
Withdrawal by Subject                0                2                2 
Protocol Violation                1                0                0 
Moved                1                0                0 
Worsening depression                0                0                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Paroxetine Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Venlafaxine Extended Release Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Placebo Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Paroxetine   Venlafaxine Extended Release   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   34   39   115 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.2  (9.8)   62.5  (11.4)   62.7  (11.0)   63.5  (10.7) 
Gender 
[Units: Participants]
       
Female   11   15   16   42 
Male   31   19   23   73 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   4   4   4   12 
Not Hispanic or Latino   38   30   35   103 
Unknown or Not Reported   0   0   0   0 
Education beyond High School 
[Units: Participants]
       
Beyond High School   35   27   27   89 
Not beyond High School   7   7   12   26 
Marriage 
[Units: Participants]
       
Married   27   27   28   82 
Not married   15   7   11   33 
Major Depression 
[Units: Participants]
       
Yes   29   22   22   73 
No   13   12   17   42 
Past Antidepressant Use 
[Units: Participants]
       
Yes   3   2   5   10 
No   39   32   34   105 
HAM-D Score [1] 
[Units: Hamilton Depression Score]
Mean (Standard Deviation)
 22.2  (6.5)   21.2  (6.0)   21.4  (4.8)   21.6  (5.8) 
[1] 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.
MADRS Score [1] 
[Units: Score]
Mean (Standard Deviation)
 21.0  (6.8)   19.4  (7.9)   19.9  (5.9)   20.1  (6.9) 
[1] Montgomery-Asberg Depression Rating Scale. Range 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.
GDS Score [1] 
[Units: Score]
Mean (Standard Deviation)
 15.5  (6.2)   15.1  (5.8)   15.0  (4.9)   15.2  (5.6) 
[1] Geriatric Depression Scale. Range 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.
BDI-II Score [1] 
[Units: Score]
Mean (Standard Deviation)
 17.2  (9.2)   17.1  (9.1)   17.5  (7.4)   17.3  (8.6) 
[1] Beck Depression Inventory II. Range 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.
Years since PD Onset 
[Units: Years]
Mean (Standard Deviation)
 6.7  (5.8)   7.4  (4.2)   7.0  (3.8)   7.0  (4.6) 
Years since PD Diagnosis 
[Units: Years]
Mean (Standard Deviation)
 5.2  (5.9)   4.7  (3.7)   4.9  (3.6)   4.9  (4.4) 
Hoehn and Yahr Stage [1] 
[Units: Participants]
       
1.0-1.5 (Unilateral Parkinson's Disease)   3   0   3   6 
2.0-2.5 (Mild Bilateral Parkinson's Disease)   32   29   31   92 
3.0-4.0 (Moderate to Severe Bilateral Parkinson's)   7   5   5   17 
[1] As the stage rating increases, the severity of the disease increases. Ranges from 1.0 to 5.0.
UPDRS Score [1] 
[Units: Score]
Mean (Standard Deviation)
       
Mental   4.8  (2.4)   5.2  (1.9)   4.6  (2.0)   4.9  (2.1) 
Activities of Daily Living   27.3  (9.6)   26.8  (12.3)   26.4  (11.5)   26.8  (11.1) 
Motor   10.6  (6.7)   11.4  (7.4)   10.8  (5.5)   10.9  (6.5) 
Total   42.7  (14.9)   43.1  (19.0)   41.7  (15.9)   42.5  (16.6) 
[1] 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 score = 0.
Schwab/England Activities of Daily Living Score ("On") [1] 
[Units: Score]
Mean (Standard Deviation)
 82.9  (11.2)   80.3  (14.6)   80.8  (13.4)   81.3  (13.1) 
[1] Schwab and England Activities of Daily Living Scale (S/E ADL). Range 0-100%. Higher percentage indicates higher level of function and lower impact of disease on life activities.
Motor Fluctuations 
[Units: Participants]
       
Yes   25   20   24   69 
No   17   14   15   46 
PDQ-39 Total [1] 
[Units: Score on PDQ-39 Questionnaire]
Mean (Standard Deviation)
 36.8  (16.3)   37.2  (15.6)   39.6  (14.8)   37.9  (15.6) 
[1] Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.
Short Form-36 Health Survey Scores [1] 
[Units: Score]
Mean (Standard Deviation)
       
Physical Component Summary   37.5  (9.3)   36.2  (10.3)   37.1  (10.4)   36.9  (10) 
Mental Component Summary   41.4  (8.8)   38.3  (10.1)   40.0  (9.3)   39.9  (9.4) 
[1] Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.
Snaith CAS [1] 
[Units: Score]
Mean (Standard Deviation)
 6.7  (3.9)   7.8  (4.5)   7.5  (4.3)   7.3  (4.2) 
[1] Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.
Mini Mental State Examination Score [1] 
[Units: Score]
Mean (Standard Deviation)
 28.7  (1.4)   28.9  (1.8)   28.5  (1.5)   28.7  (1.6) 
[1] Mini Mental State Examination (MMSE). Range 0-30. Higher score indicates better cognitive status. Score less than 9 = severe cognitive impairment, 10-20 moderate impairment, 21-24 mild impairment, 25 and greater considered normal.
BPRS Score [1] 
[Units: Score]
Mean (Standard Deviation)
 33.6  (10.7)   35.7  (8.9)   34.4  (9.3)   34.6  (9.6) 
[1] Brief Psychiatric Rating Scale. Maximum score 126, minimum score 0. Higher score indicates greater psychiatric difficulties.
Treatment of PD - Levodopa [1] 
[Units: Participants]
       
Treatment - Yes   38   27   32   97 
Treatment - No   4   7   7   18 
[1] Participants taking Levodopa for treatment of Parkinson's Disease.
Treatment of PD - Agonist [1] 
[Units: Participants]
       
Treatment - Yes   17   13   12   42 
Treatment - No   25   21   27   73 
[1] Participants taking Agonist for treatment of Parkinson's Disease.
Treatment for PD - Catechol O-methyltransferase Inhibitor [1] 
[Units: Participants]
       
Treatment - Yes   9   9   11   29 
Treatment - No   33   25   28   86 
[1] Participants taking Catechol O-methyltransferase (COMT) Inhibitor for treatment of Parkinson's Disease.
Treatment of PD - Amantadine [1] 
[Units: Participants]
       
Treatment - Yes   6   4   6   16 
Treatment - No   36   30   33   99 
[1] Participants taking Amantadine for treatment of Parkinson's Disease.
Treatment of PD - Anticholinergic [1] 
[Units: Participants]
       
Treatment - Yes   3   4   3   10 
Treatment - No   39   30   36   105 
[1] Participants taking Anticholinergic for treatment of Parkinson's Disease.


  Outcome Measures

1.  Primary:   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 ]

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

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

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

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

6.  Secondary:   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 ]

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

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

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   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 ]

14.  Secondary:   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 ]

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

16.  Secondary:   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 ]

17.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Irene H. Richard, MD
Organization: University of Rochester Medical Center
phone: 585-341-7500
e-mail: irene_richard@urmc.rochester.edu


Publications:
Dubovsky S. Geriatric Neuropsychopharmacology. In: Coffey C, Cummings J, eds. Textbook of Geriatric Neuropsychiatry. Washington, DC: American Psychiatric Press, 1994:595-631.
Applebaum PS, Grisso T. MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research. Sarasota, FL: Professional Resource Press, 2001.
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th ed. Washington, DC, 1994.
Spitzer RL, Gibbon M, Williams JBW. Structured clinical interview for Axis I DSM-IV disorders: Biometrics Research Department. New York State Psychiatric Institute 1994.
Conners C, Barkley R. Rating scales and checklists for psychopharmacologic trials. Psychopharm Bull 1985;21:80-854.
Fahn S, Elton RL. Unified Parkinson's Disease Rating Scale. In: Fahn S, Marsden CD, Calne DB, Goldstein M, eds. Recent Developments in Parkinson's Disease. Florham Park, NJ: MacMillan Healthcare Information, 1992:153-163.
Little RJA, Rubin DB. Statistical Analysis with Missing Data, Second Edition. Hoboken: John Wiley and Sons, 2002.


Responsible Party: Irene Richard, University of Rochester
ClinicalTrials.gov Identifier: NCT00086190     History of Changes
Other Study ID Numbers: R01NS046487 ( U.S. NIH Grant/Contract )
First Submitted: June 28, 2004
First Posted: June 29, 2004
Results First Submitted: January 11, 2012
Results First Posted: January 4, 2013
Last Update Posted: January 4, 2013