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L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults

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ClinicalTrials.gov Identifier: NCT03761030
Recruitment Status : Terminated (The project end date was reached prior to the full sample enrollment)
First Posted : December 3, 2018
Results First Posted : May 22, 2023
Last Update Posted : May 22, 2023
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Bret Rutherford, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Major Depressive Disorder
Dysthymia
Depression
Interventions Drug: L-DOPA
Drug: Placebo Oral Tablet
Enrollment 51
Recruitment Details  
Pre-assignment Details In total, 51 subjects were enrolled. Of the 51 enrolled, 20 subjects were found to be ineligible or did not continue in the study after enrolling. Thus, 51 participants enrolled and 31 were assigned to a treatment group and began the study.
Arm/Group Title L-DOPA Arm Placebo Arm
Hide Arm/Group Description

Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose

L-DOPA: We will be using generic sinemet 25/100 tablets in this study.

Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.

Placebo Oral Tablet: 25/100 placebo tablets

Period Title: Overall Study
Started 15 16
Completed 13 12
Not Completed 2 4
Arm/Group Title L-DOPA Arm Placebo Arm Total
Hide Arm/Group Description

Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose

L-DOPA: We will be using generic sinemet 25/100 tablets in this study.

Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.

Placebo Oral Tablet: 25/100 placebo tablets

Total of all reporting groups
Overall Number of Baseline Participants 15 16 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 31 participants
69.0  (7.3) 66.7  (6.1) 67.8  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Female
9
  60.0%
10
  62.5%
19
  61.3%
Male
6
  40.0%
6
  37.5%
12
  38.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Hispanic or Latino
1
   6.7%
4
  25.0%
5
  16.1%
Not Hispanic or Latino
13
  86.7%
11
  68.8%
24
  77.4%
Unknown or Not Reported
1
   6.7%
1
   6.3%
2
   6.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   6.3%
1
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  26.7%
3
  18.8%
7
  22.6%
White
9
  60.0%
10
  62.5%
19
  61.3%
More than one race
2
  13.3%
2
  12.5%
4
  12.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 16 participants 31 participants
15 16 31
Hamilton Rating Scale for Depression (24 item)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 16 participants 31 participants
21.1  (4.7) 20.3  (3.9) 20.7  (4.3)
[1]
Measure Description: The Hamilton Rating Scale for Depression (HRSD) is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Clinical Global Impressions--Severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 16 participants 31 participants
3.7  (0.6) 4.3  (0.7) 4.0  (0.7)
[1]
Measure Description: The Clinical Global Impressions--Severity (CGI-S) scale measures the clinician's assessment of global illness severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores denote more severe illness.
1.Primary Outcome
Title Change From Baseline Hamilton Rating Scale for Depression 24-Item Scale to Study Completion (8 Weeks)
Hide Description The Hamilton Rating Scale for Depression (HRSD) is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Time Frame Change from Baseline to 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with Week 8 data available were analyzed.
Arm/Group Title L-DOPA Arm Placebo Arm
Hide Arm/Group Description:

Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose

L-DOPA: We will be using generic sinemet 25/100 tablets in this study.

Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.

Placebo Oral Tablet: 25/100 placebo tablets

Overall Number of Participants Analyzed 12 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.2  (6.4) -3.6  (5.8)
2.Secondary Outcome
Title Digit Symbol Test
Hide Description The Digit Symbol test is a neuropsychological test measuring information processing speed. It consists of digit-symbol pairs (e.g. 1/-,2/┴ ... 7/Λ,8/X,9/=) followed by a list of digits. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured. Score ranges from 0-133, with higher scores indicating higher information processing speed. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Time Frame Change from Baseline to 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with Week 8 data available were analyzed.
Arm/Group Title L-DOPA Arm Placebo Arm
Hide Arm/Group Description:

Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose

L-DOPA: We will be using generic sinemet 25/100 tablets in this study.

Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.

Placebo Oral Tablet: 25/100 placebo tablets

Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: Number of items correctly completed
2.8  (4.0) 5.0  (3.5)
3.Secondary Outcome
Title Single Task Gait Speed
Hide Description Patients' gait was assessed as walking speed in cm/s on a 15' walking course. Patients walked at their usual or normal speed for a total of 27' (starting and ending at a point 6 feet prior to and after the 15' course to eliminate acceleration and deceleration effects). Two trials were completed, and gait speed was based on the average of 2 trials. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Time Frame Change from Baseline to 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with Week 8 data available were analyzed
Arm/Group Title L-DOPA Arm Placebo Arm
Hide Arm/Group Description:

Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose

L-DOPA: We will be using generic sinemet 25/100 tablets in this study.

Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.

Placebo Oral Tablet: 25/100 placebo tablets

Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: cm/s
3.7  (14.9) -3.8  (14.7)
4.Secondary Outcome
Title Inventory of Depressive Symptomatology--Self Report (IDS-SR)
Hide Description The Inventory of Depressive Symptomatology--Self Report (IDS-SR) is a rating scale for depressive symptoms based on standard diagnostic criteria for Major Depressive Disorder. The scale ranges from 0-84 with higher scores indicating more severe depression. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Time Frame Change from Baseline to 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available Week 8 data were analyzed
Arm/Group Title L-DOPA Arm Placebo Arm
Hide Arm/Group Description:

Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose

L-DOPA: We will be using generic sinemet 25/100 tablets in this study.

Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.

Placebo Oral Tablet: 25/100 placebo tablets

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.8  (7.1) -12.1  (15.0)
5.Secondary Outcome
Title Pattern Comparison Test
Hide Description This test required participants to identify whether two visual patterns are the "same" or "not the same" (responses were made by pressing a "yes" or "no" button). Patterns were either identical or varied on one of three dimensions: color (all ages), adding/taking something away (all ages), or one versus many. Scores reflect the number of correct items completed in 90 s, with scores ranging from a minimum of 0 to a maximum of 30. Items were designed to minimize the number of errors that were made. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Time Frame Change from Baseline to 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available Week 8 data were analyzed
Arm/Group Title L-DOPA Arm Placebo Arm
Hide Arm/Group Description:

Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose

L-DOPA: We will be using generic sinemet 25/100 tablets in this study.

Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.

Placebo Oral Tablet: 25/100 placebo tablets

Overall Number of Participants Analyzed 11 10
Mean (Standard Deviation)
Unit of Measure: Number of items correctly completed
0.6  (2.1) 1.2  (2.3)
6.Secondary Outcome
Title Letter Comparison Test
Hide Description Subjects were asked to determine whether two strings of letters are the same or different. There are 3 pages and the subject is given 30 seconds per page. Scoring is based on the number answered correctly. Scores range from 0 to 21, with the higher the number, the better the score. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating means and standard deviations.
Time Frame Change from Baseline to 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available Week 8 data were analyzed
Arm/Group Title L-DOPA Arm Placebo Arm
Hide Arm/Group Description:

Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose

L-DOPA: We will be using generic sinemet 25/100 tablets in this study.

Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.

Placebo Oral Tablet: 25/100 placebo tablets

Overall Number of Participants Analyzed 11 10
Mean (Standard Deviation)
Unit of Measure: Number of items correctly completed
1.2  (1.6) 0.7  (1.4)
Time Frame Subjects were monitored over a period of 8 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title L-DOPA Arm Placebo Arm
Hide Arm/Group Description

Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa (37.5 mg carbidopa/150mg levodopa twice daily and placebo once daily) for one week, and finally increase to 112.5mg carbidopa/450mg levodopa (37.5 mg carbidopa/150mg levodopa three times daily and no placebo) for the final six weeks. Each subject assigned to the L-DOPA arm will be titrated to 450mg L-DOPA unless they cannot tolerate higher doses, in which case subjects will have their dosage reduced to the maximum tolerable dose

L-DOPA: We will be using generic sinemet 25/100 tablets in this study.

Subjects assigned to the placebo arm will take placebo oral tablet three times daily throughout the study.

Placebo Oral Tablet: 25/100 placebo tablets

All-Cause Mortality
L-DOPA Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      1/16 (6.25%)    
Hide Serious Adverse Events
L-DOPA Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      2/16 (12.50%)    
Infections and infestations     
Hospitalization for infection   0/15 (0.00%)  0 1/16 (6.25%)  1
Psychiatric disorders     
Death by suicide   0/15 (0.00%)  0 1/16 (6.25%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
L-DOPA Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/15 (93.33%)      15/16 (93.75%)    
Eye disorders     
Blurred vision   2/15 (13.33%)  2 2/16 (12.50%)  2
Gastrointestinal disorders     
Nausea   5/15 (33.33%)  8 3/16 (18.75%)  3
Dry mouth   5/15 (33.33%)  5 4/16 (25.00%)  4
Diarrhea   3/15 (20.00%)  3 2/16 (12.50%)  2
Constipation   2/15 (13.33%)  2 2/16 (12.50%)  3
Stomach/throat discomfort   2/15 (13.33%)  2 1/16 (6.25%)  1
Increased appetite   1/15 (6.67%)  1 0/16 (0.00%)  0
Weight loss   1/15 (6.67%)  1 0/16 (0.00%)  0
Decreased appetite   0/15 (0.00%)  0 4/16 (25.00%)  4
Diverticulitis   0/15 (0.00%)  0 1/16 (6.25%)  1
General disorders     
Hot flashes   2/15 (13.33%)  2 0/16 (0.00%)  0
Malaise/weakness   1/15 (6.67%)  1 2/16 (12.50%)  2
Poor balance   1/15 (6.67%)  1 1/16 (6.25%)  1
Fall   0/15 (0.00%)  0 1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders     
Toe fracture   0/15 (0.00%)  0 1/16 (6.25%)  1
Neck/back pain   5/15 (33.33%)  6 1/16 (6.25%)  1
Joint/limb pain   4/15 (26.67%)  4 0/16 (0.00%)  0
Leg/ankle swelling   2/15 (13.33%)  2 0/16 (0.00%)  0
Muscle tightness/rigidity   1/15 (6.67%)  1 3/16 (18.75%)  3
Bursitis   0/15 (0.00%)  0 1/16 (6.25%)  1
Nervous system disorders     
Incidental MRI finding   2/15 (13.33%)  2 0/16 (0.00%)  0
Headache   4/15 (26.67%)  4 5/16 (31.25%)  5
Numbness   1/15 (6.67%)  1 0/16 (0.00%)  0
Word finding difficulty   0/15 (0.00%)  0 1/16 (6.25%)  1
Psychiatric disorders     
Anxiety during neuroimaging   0/15 (0.00%)  0 2/16 (12.50%)  2
Insomnia   6/15 (40.00%)  7 6/16 (37.50%)  7
Drowsiness   5/15 (33.33%)  6 2/16 (12.50%)  2
Excitement   2/15 (13.33%)  2 0/16 (0.00%)  0
Vivid dreams   1/15 (6.67%)  1 3/16 (18.75%)  3
Irritability   1/15 (6.67%)  1 0/16 (0.00%)  0
Forgetfulness   0/15 (0.00%)  0 1/16 (6.25%)  1
Suicidal ideation   0/15 (0.00%)  0 1/16 (6.25%)  1
Panic   0/15 (0.00%)  0 1/16 (6.25%)  1
Renal and urinary disorders     
Increased urination   2/15 (13.33%)  2 1/16 (6.25%)  1
Urinary tract infection   1/15 (6.67%)  1 0/16 (0.00%)  0
Cloudy urine   1/15 (6.67%)  1 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Sighing   1/15 (6.67%)  1 0/16 (0.00%)  0
Nasal congestion   0/15 (0.00%)  0 1/16 (6.25%)  1
Hyperventilation   0/15 (0.00%)  0 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders     
Itching   2/15 (13.33%)  2 0/16 (0.00%)  0
Increased sweating   0/15 (0.00%)  0 1/16 (6.25%)  1
Vascular disorders     
Dizziness   6/15 (40.00%)  6 4/16 (25.00%)  4
Increased heart rate   2/15 (13.33%)  2 0/16 (0.00%)  0
Decreased heart rate   1/15 (6.67%)  1 1/16 (6.25%)  1
Abnormal heart rhythm   1/15 (6.67%)  1 0/16 (0.00%)  0
Palpitations   0/15 (0.00%)  0 2/16 (12.50%)  2
Indicates events were collected by systematic assessment
Data collected in the trial have been presented as required but are considered unreliable.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Bret Rutherford
Organization: New York State Psychiatric Institute
Phone: 646 774 8660
EMail: bret.rutherford@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: Bret Rutherford, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03761030    
Other Study ID Numbers: 7733
4R33MH110029-03 ( U.S. NIH Grant/Contract )
First Submitted: November 29, 2018
First Posted: December 3, 2018
Results First Submitted: May 2, 2023
Results First Posted: May 22, 2023
Last Update Posted: May 22, 2023