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Lexapro and Pramipexole and to Treat Major Depression

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ClinicalTrials.gov Identifier: NCT00086307
Recruitment Status : Completed
First Posted : June 30, 2004
Results First Posted : July 12, 2012
Last Update Posted : January 28, 2013
Sponsor:
Information provided by (Responsible Party):
Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depression
Interventions Drug: Pramipexole
Drug: Escitalopram
Enrollment 39

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pramipexole Escitalopram Escitalopram and Pramipexole
Hide Arm/Group Description Patients receive pramipexole and placebo. Patients receive escitalopram and placebo. Patients receive escitalopram and pramipexole.
Period Title: Overall Study
Started 13 13 13
Completed 11 12 5
Not Completed 2 1 8
Reason Not Completed
Lack of Efficacy             1             1             2
Shortness of breath and muscle spasms             1             0             0
Nausea and headaches             0             0             1
Constipation and sleepiness             0             0             1
Suicidal ideation             0             0             1
Fatigue and difficulty falling asleep             0             0             1
Withdrawal by Subject             0             0             2
Arm/Group Title Pramipexole Escitalopram Escitalopram and Pramipexole Total
Hide Arm/Group Description Patients receive pramipexole and placebo. Patients receive escitalopram and placebo. Patients receive escitalopram and pramipexole. Total of all reporting groups
Overall Number of Baseline Participants 13 13 13 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 13 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
13
 100.0%
13
 100.0%
39
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 13 participants 39 participants
44.8  (10.1) 45.6  (13.6) 45.3  (12.7) 45.3  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 13 participants 39 participants
Female
7
  53.8%
9
  69.2%
11
  84.6%
27
  69.2%
Male
6
  46.2%
4
  30.8%
2
  15.4%
12
  30.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 13 participants 39 participants
13 13 13 39
1.Primary Outcome
Title Montgomery Asberg Depression Rating Scale (MADRS)
Hide Description The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 item scale for assessing the severity of depression. Items are rated on a scale of 0 to 6, so the maximum score is 60 and the minimum is 0, where 60 is the most severe depression. Scores of 18 or greater are generally considered to indicate a moderate level of depression.
Time Frame Weekly
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients with at least one post-baseline measurement were included in the analysis.
Arm/Group Title Pramipexole Escitalopram Escitalopram and Pramipexole
Hide Arm/Group Description:
Patients receive pramipexole and placebo.
Patients receive escitalopram and placebo.
Patients receive escitalopram and pramipexole.
Overall Number of Participants Analyzed 13 13 13
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
22.629  (1.508) 26.102  (1.507) 29.455  (1.732)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole, Escitalopram, Escitalopram and Pramipexole
Comments A linear mixed model with restricted maximum likelihood estimation and a first order autoregressive covariance structure was used to examine depressive symptoms over time. Fixed factors for drug, time, and a time by drug interaction were included in the model along with the intercept. No random factors were included because the subject factor did not contribute significantly to the model. Baseline symptoms were used as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .018
Comments This is the omnibus effect of drug.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.826
Confidence Interval (2-Sided) 95%
1.111 to 12.541
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.296
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pramipexole, Escitalopram and Pramipexole
Comments Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the pramipexole and escitalopram combination group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .014
Comments The significance level was adjusted using a Bonferroni correction.
Method Post hoc simple effects test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.826
Confidence Interval (2-Sided) 95%
1.111 to 12.541
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.296
Estimation Comments The pramipexole group had a lower MADRS score than the pramipexole and escitalopram group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Escitalopram, Escitalopram and Pramipexole
Comments Post-hoc simple effects tests with Bonferroni correction were used to compare the escitalopram group to the pramipexole and escitalopram combination group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .454
Comments The significance level was adjusted using a Bonferroni correction.
Method Post hoc simple effects test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.353
Confidence Interval (2-Sided) 95%
-2.360 to 9.066
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.296
Estimation Comments The escitalopram group had a lower MADRS score than the pramipexole and escitalopram group.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pramipexole, Escitalopram
Comments Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the escitalopram group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .349
Comments The significance level was adjusted using a Bonferroni correction.
Method Post hoc simple effects test
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.473
Confidence Interval (2-Sided) 95%
-1.942 to 8.888
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.162
Estimation Comments The pramipexole group had a lower MADRS score than the escitalopram group.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pramipexole Escitalopram Escitalopram and Pramipexole
Hide Arm/Group Description Patients receive pramipexole and placebo. Patients receive escitalopram and placebo. Patients receive escitalopram and pramipexole.
All-Cause Mortality
Pramipexole Escitalopram Escitalopram and Pramipexole
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pramipexole Escitalopram Escitalopram and Pramipexole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pramipexole Escitalopram Escitalopram and Pramipexole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/13 (61.54%)      12/13 (92.31%)      11/13 (84.62%)    
Cardiac disorders       
Tachycardia   0/13 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1
Hypertension   0/13 (0.00%)  0 1/13 (7.69%)  1 1/13 (7.69%)  1
Ear and labyrinth disorders       
Earache   1/13 (7.69%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0
Tinnitus   0/13 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0
Eye disorders       
Eye Irritation   1/13 (7.69%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0
Gastrointestinal disorders       
Abdominal Discomfort   1/13 (7.69%)  1 3/13 (23.08%)  3 2/13 (15.38%)  2
Diarrhea   1/13 (7.69%)  1 0/13 (0.00%)  0 1/13 (7.69%)  1
General disorders       
Headache   3/13 (23.08%)  3 3/13 (23.08%)  3 4/13 (30.77%)  4
Dizziness   0/13 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0
Dry Mouth   0/13 (0.00%)  0 1/13 (7.69%)  1 1/13 (7.69%)  1
Nasal Congestion   0/13 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1
Sore Throat   0/13 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1
Nausea   3/13 (23.08%)  3 1/13 (7.69%)  1 5/13 (38.46%)  5
Vomiting   1/13 (7.69%)  1 0/13 (0.00%)  0 1/13 (7.69%)  1
Flatulence   2/13 (15.38%)  2 1/13 (7.69%)  1 1/13 (7.69%)  1
Stool Discoloration   1/13 (7.69%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0
Appetite Increase   0/13 (0.00%)  0 3/13 (23.08%)  3 2/13 (15.38%)  2
Appetite Decrease   1/13 (7.69%)  1 1/13 (7.69%)  1 4/13 (30.77%)  4
Increased Thirst   1/13 (7.69%)  1 2/13 (15.38%)  2 1/13 (7.69%)  1
Increased Libido   1/13 (7.69%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0
Decreased Libido   1/13 (7.69%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0
Sexual Dysfunction   0/13 (0.00%)  0 1/13 (7.69%)  1 1/13 (7.69%)  1
Tic Movements   0/13 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0
Hair Problems   0/13 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1
Fatigue   0/13 (0.00%)  0 3/13 (23.08%)  3 0/13 (0.00%)  0
Increased Motor Activity   0/13 (0.00%)  0 0/13 (0.00%)  0 2/13 (15.38%)  2
Decreased Motor Activity   1/13 (7.69%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0
Difficulty Falling Asleep   0/13 (0.00%)  0 1/13 (7.69%)  1 5/13 (38.46%)  5
Early Morning Awakening   0/13 (0.00%)  0 2/13 (15.38%)  2 4/13 (30.77%)  4
Interrupted Sleep   1/13 (7.69%)  1 2/13 (15.38%)  2 3/13 (23.08%)  3
Drowsiness   0/13 (0.00%)  0 4/13 (30.77%)  4 0/13 (0.00%)  0
Slurred Speech   0/13 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1
Concentration Difficulty   0/13 (0.00%)  0 1/13 (7.69%)  1 2/13 (15.38%)  2
Memory Problems   1/13 (7.69%)  1 1/13 (7.69%)  1 1/13 (7.69%)  1
Accidental injury   0/13 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders       
Muscle/Bone/Joint Pain   0/13 (0.00%)  0 3/13 (23.08%)  3 3/13 (23.08%)  3
Psychiatric disorders       
Depression   1/13 (7.69%)  1 2/13 (15.38%)  2 2/13 (15.38%)  2
Anxiety   2/13 (15.38%)  2 3/13 (23.08%)  3 4/13 (30.77%)  4
Irritability   1/13 (7.69%)  1 1/13 (7.69%)  1 1/13 (7.69%)  1
Suicidal Ideas   0/13 (0.00%)  0 0/13 (0.00%)  0 1/13 (7.69%)  1
Renal and urinary disorders       
Constipation   0/13 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0
Painful Urination   1/13 (7.69%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0
Increased Frequency of Urination   0/13 (0.00%)  0 1/13 (7.69%)  1 0/13 (0.00%)  0
Reproductive system and breast disorders       
Menstrual Irregularity   1/7 (14.29%)  1 0/9 (0.00%)  0 1/11 (9.09%)  1
Premenstrual Tension   0/7 (0.00%)  0 1/9 (11.11%)  1 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Upper Respiratory Ailment   1/13 (7.69%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0
Shortness of breath   1/13 (7.69%)  1 0/13 (0.00%)  0 0/13 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatological Irritation   3/13 (23.08%)  3 1/13 (7.69%)  1 0/13 (0.00%)  0
Breast pain or swelling   1/7 (14.29%)  1 0/9 (0.00%)  0 0/11 (0.00%)  0
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
Name/Title: Dr. Carlos A. Zarate
Organization: NIMH
Phone: 301-451-0861
Responsible Party: Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00086307     History of Changes
Other Study ID Numbers: 040227
04-M-0227
First Submitted: June 29, 2004
First Posted: June 30, 2004
Results First Submitted: June 7, 2012
Results First Posted: July 12, 2012
Last Update Posted: January 28, 2013