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Imaging Dopamine Release in Depression

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ClinicalTrials.gov Identifier: NCT02033369
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : November 21, 2017
Last Update Posted : December 18, 2018
Sponsor:
Collaborators:
Columbia University
Research Foundation for Mental Hygiene, Inc.
Mclean Hospital
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Franklin Schneier, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Major Depressive Disorder
Intervention Drug: Pramipexole
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MDD Patients Healthy Controls
Hide Arm/Group Description

Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.

Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day

Individuals without depression
Period Title: Overall Study
Started 26 26
Completed 21 21
Not Completed 5 5
Reason Not Completed
Physician Decision             1             2
Not a good demographic match             0             2
Withdrawal by Subject             1             1
Lost to Follow-up             1             0
Protocol Violation             2             0
Arm/Group Title MDD Patients Healthy Control Patients Total
Hide Arm/Group Description

Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.

Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day

Healthy control patients did not receive study medication and only have baseline measures. Total of all reporting groups
Overall Number of Baseline Participants 26 25 51
Hide Baseline Analysis Population Description
Baseline information was collected for 26 patients with MDD and 25 HC control subjects. One HC subject signed consent but was withdrawn from the study before completing any assessments due to not matching well.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 25 participants 51 participants
26.5  (6.1) 26.5  (5.6) 26.5  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 51 participants
Female
13
  50.0%
12
  48.0%
25
  49.0%
Male
13
  50.0%
13
  52.0%
26
  51.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 51 participants
Hispanic or Latino
10
  38.5%
9
  36.0%
19
  37.3%
Not Hispanic or Latino
16
  61.5%
16
  64.0%
32
  62.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  11.5%
3
  12.0%
6
  11.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  19.2%
5
  20.0%
10
  19.6%
White
12
  46.2%
10
  40.0%
22
  43.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
  23.1%
7
  28.0%
13
  25.5%
Hamilton Rating Scale for Depression   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 26 participants 25 participants 51 participants
20.3  (2.7) 0.2  (0.4) 10.4  (10.3)
[1]
Measure Description: Hamilton Rating Scale for Depression (HRSD), 17-item version. This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 6, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression)
Snaith Hamilton Pleasure Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 26 participants 25 participants 51 participants
31.9  (6.5) 18.9  (4.8) 25.7  (8.7)
[1]
Measure Description: Fourteen-item self-rated anhedonia scale. Items were comprised of statements that participants rated as "strongly disagree" (1), "disagree" (2), "agree" (3), or "strongly agree" (4). The lowest possible score was 14, the highest possible score was 56.
Temporal Experience of Pleasure Scale - Anticipatory Subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 26 participants 25 participants 51 participants
36.1  (8.0) 49.0  (5.2) 42.4  (9.3)
[1]
Measure Description:

A validated self-rated subscale assessing anticipatory pleasure. It will be used for exploratory analyses of anhedonia.

18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108.

Mood and Anxiety Symptom Questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 26 participants 25 participants 51 participants
174.5  (28.6) 83.9  (13.3) 130.1  (50.8)
[1]
Measure Description: Change in Mood and Anxiety Symptom Questionnaire, Short Form. A 62-item scale assessing anxiety and depression. Items were measured on a scale of 1-5, higher number indicating higher levels of symptoms.The lowest possible score was 62, and the highest 310.
Apathy Evaluation Rating Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 26 participants 25 participants 51 participants
41.8  (9.7) 23.8  (4.9) 33.0  (11.8)
[1]
Measure Description: A validated self-rated 18 item scale assessing apathy. Items were rated from 1 (not at all true) to 4 (very true). Higher scores indicate lower apathy, lower scores indicate higher apathy. Lowest possible score is 18, highest possible score is 72.
Clinical Global Impression Severity   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 26 participants 25 participants 51 participants
3.9  (0.7) 1.0  (0) 1.9  (0.4)
[1]
Measure Description: Clinical Global Impression - severity. Seven-point likert scale rating clinical severity of mental illness from 1 (least severe) to 7 ( most severe). Physician-rated scale. One item
[2]
Measure Analysis Population Description: Only 22 MDD patients started treatment. Healthy controls, as per study design, did not receive treatment.
Temporal Experience of Pleasure Scale - Consummatory Subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 26 participants 25 participants 51 participants
29.9  (7.6) 38.4  (7.2) 34.1  (8.5)
[1]
Measure Description:

A validated self-rated subscale assessing consummatory pleasure. It will be used for exploratory analyses of anhedonia.

18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108.

1.Primary Outcome
Title Change in Hamilton Rating Scale for Depression
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
Arm/Group Title Pramipexole
Hide Arm/Group Description:

Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.

Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.4  (5.4)
2.Secondary Outcome
Title Change in Snaith Hamilton Pleasure Scale
Hide Description Fourteen-item self-rated anhedonia scale. Items were comprised of statements that participants rated as "strongly disagree" (1), "disagree" (2), "agree" (3), or "strongly agree" (4). The lowest possible score was 14, the highest possible score was 56.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
Arm/Group Title Pramipexole
Hide Arm/Group Description:

Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.

Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
26  (7.51)
3.Secondary Outcome
Title Change in Temporal Experience of Pleasure Scale - Anticipatory Subscale
Hide Description

A validated self-rated scale shown to assess anticipatory pleasure. It will be used for exploratory analyses of anhedonia.

18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108.

Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
Arm/Group Title Pramipexole
Hide Arm/Group Description:

Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.

Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
43.2  (7.9)
4.Secondary Outcome
Title Change in Mood and Anxiety Symptom Questionnaire, Short Form
Hide Description Change in Mood and Anxiety Symptom Questionnaire, Short Form. A 62-item scale assessing anxiety and depression. Items were measured on a scale of 1-5, higher number indicating higher levels of symptoms.The lowest possible score was 62, and the highest 310.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
Arm/Group Title Pramipexole
Hide Arm/Group Description:

Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.

Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
123.1  (36.3)
5.Secondary Outcome
Title Change in the Apathy Evaluation Rating Scale
Hide Description A validated self-rated 18 item scale assessing apathy. Items were rated from 1 (not at all true) to 4 (very true). Higher scores indicate lower apathy, lower scores indicate higher apathy. Lowest possible score is 18, highest possible score is 72.
Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
Arm/Group Title Pramipexole
Hide Arm/Group Description:

Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.

Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
31.7  (9.5)
6.Secondary Outcome
Title Change in Clinical Global Improvement - Severity Scale
Hide Description Seven-point Likert scale rating clinical severity of mental illness from 1 (least severe) to 7 ( most severe). Physician-rated scale. One item.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
Arm/Group Title Pramipexole
Hide Arm/Group Description:

Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.

Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.59  (1.10)
7.Secondary Outcome
Title Change in Temporal Experiences of Pleasure Scale -- Consummatory Subscale
Hide Description

A validated self-rated scale shown to assess consummatory pleasure. It will be used for exploratory analyses of anhedonia.

18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108.

Time Frame Baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.
Arm/Group Title Pramipexole
Hide Arm/Group Description:

Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg.

Pramipexole: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 – 2.5 mg/day

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
35.6  (6.6)
Time Frame 6 weeks
Adverse Event Reporting Description

Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment.

Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.

 
Arm/Group Title MDD Patients
Hide Arm/Group Description Only patients with MDD received treatment. There was only one arm.
All-Cause Mortality
MDD Patients
Affected / at Risk (%)
Total   0/22 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
MDD Patients
Affected / at Risk (%) # Events
Total   0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MDD Patients
Affected / at Risk (%) # Events
Total   22/22 (100.00%)    
Blood and lymphatic system disorders   
Bruising   2/22 (9.09%)  2
Eye disorders   
Blurry Vision   6/22 (27.27%)  6
Gastrointestinal disorders   
nausea   18/22 (81.82%)  18
Heartburn   7/22 (31.82%)  7
Vomiting   7/22 (31.82%)  7
Decreased Appetite   6/22 (27.27%)  6
Increased Appetite   6/22 (27.27%)  6
Constipation   4/22 (18.18%)  4
Diarrhea   5/22 (22.73%)  5
General disorders   
Dry Mouth   10/22 (45.45%)  10
fatigue   2/22 (9.09%)  2
Musculoskeletal and connective tissue disorders   
tremor   2/22 (9.09%)  2
Impaired Coordination   4/22 (18.18%)  4
Nervous system disorders   
headache   13/22 (59.09%)  13
Lightheadedness   10/22 (45.45%)  10
Dizziness   8/22 (36.36%)  8
Psychiatric disorders   
Restlessness   9/22 (40.91%)  9
Insomnia   9/22 (40.91%)  9
somnolence   11/22 (50.00%)  11
Sleep Attacks   5/22 (22.73%)  5
Forgetfulness   7/22 (31.82%)  7
Impaired Concentration   2/22 (9.09%)  2
compulsive behaviorws   3/22 (13.64%)  3
Reproductive system and breast disorders   
decreased libido   7/22 (31.82%)  7
Sexual Dysfunction   3/22 (13.64%)  3
Skin and subcutaneous tissue disorders   
Sweating   4/22 (18.18%)  4
Skin Problems   5/22 (22.73%)  5
Indicates events were collected by systematic assessment
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: Franklin Schneier, MD
Organization: NYSPI
Phone: 646-774-8041
EMail: fschneier@nyspi.columbia.edu
Publications:
Layout table for additonal information
Responsible Party: Franklin Schneier, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02033369     History of Changes
Other Study ID Numbers: #6853
1R01MH099322-01A1 ( U.S. NIH Grant/Contract )
First Submitted: January 9, 2014
First Posted: January 10, 2014
Results First Submitted: June 29, 2017
Results First Posted: November 21, 2017
Last Update Posted: December 18, 2018