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Lexapro and Pramipexole and to Treat Major Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00086307
First received: June 29, 2004
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
Results First Received: June 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depression
Interventions: Drug: Pramipexole
Drug: Escitalopram

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
Pramipexole Patients receive pramipexole and placebo.
Escitalopram Patients receive escitalopram and placebo.
Escitalopram and Pramipexole Patients receive escitalopram and pramipexole.

Participant Flow:   Overall Study
    Pramipexole     Escitalopram     Escitalopram and Pramipexole  
STARTED     13     13     13  
COMPLETED     11     12     5  
NOT COMPLETED     2     1     8  
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  



  Baseline Characteristics
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Reporting Groups
  Description
Pramipexole Patients receive pramipexole and placebo.
Escitalopram Patients receive escitalopram and placebo.
Escitalopram and Pramipexole Patients receive escitalopram and pramipexole.
Total Total of all reporting groups

Baseline Measures
    Pramipexole     Escitalopram     Escitalopram and Pramipexole     Total  
Number of Participants  
[units: participants]
 		  13     13     13     39  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     13     13     13     39  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  44.8  ± 10.1     45.6  ± 13.6     45.3  ± 12.7     45.3  ± 11.9  
Gender  
[units: participants]
 		       
Female     7     9     11     27  
Male     6     4     2     12  
Region of Enrollment  
[units: participants]
 		       
United States     13     13     13     39  



  Outcome Measures

1.  Primary:   Montgomery Asberg Depression Rating Scale (MADRS)   [ Time Frame: Weekly ]
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Measure Type Primary
Measure Title Montgomery Asberg Depression Rating Scale (MADRS)
Measure 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  
Safety Issue No  

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.
All patients with at least one post-baseline measurement were included in the analysis.

Reporting Groups
  Description
Pramipexole Patients receive pramipexole and placebo.
Escitalopram Patients receive escitalopram and placebo.
Escitalopram and Pramipexole Patients receive escitalopram and pramipexole.

Measured Values
    Pramipexole     Escitalopram     Escitalopram and Pramipexole  
Number of Participants Analyzed  
[units: participants]
 		  13     13     13  
Montgomery Asberg Depression Rating Scale (MADRS)  
[units: Score on a scale]
Least Squares Mean ± Standard Error 		  22.629  ± 1.508     26.102  ± 1.507     29.455  ± 1.732  


Statistical Analysis 1 for Montgomery Asberg Depression Rating Scale (MADRS)
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] .018
Mean Difference (Net) [4] 6.826
Standard Error of the mean ± 2.296
95% Confidence Interval ( 1.111 to 12.541 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  This is the omnibus effect of drug.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Montgomery Asberg Depression Rating Scale (MADRS)
Groups [1] Pramipexole vs. Escitalopram and Pramipexole
Method [2] Post hoc simple effects test
P Value [3] .014
Mean Difference (Net) [4] 6.826
Standard Error of the mean ± 2.296
95% Confidence Interval ( 1.111 to 12.541 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the pramipexole and escitalopram combination group.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The significance level was adjusted using a Bonferroni correction.
[4] Other relevant estimation information:
  The pramipexole group had a lower MADRS score than the pramipexole and escitalopram group.

Statistical Analysis 3 for Montgomery Asberg Depression Rating Scale (MADRS)
Groups [1] Escitalopram vs. Escitalopram and Pramipexole
Method [2] Post hoc simple effects test
P Value [3] .454
Mean Difference (Net) [4] 3.353
Standard Error of the mean ± 2.296
95% Confidence Interval ( -2.360 to 9.066 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Post-hoc simple effects tests with Bonferroni correction were used to compare the escitalopram group to the pramipexole and escitalopram combination group.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The significance level was adjusted using a Bonferroni correction.
[4] Other relevant estimation information:
  The escitalopram group had a lower MADRS score than the pramipexole and escitalopram group.

Statistical Analysis 4 for Montgomery Asberg Depression Rating Scale (MADRS)
Groups [1] Pramipexole vs. Escitalopram
Method [2] Post hoc simple effects test
P Value [3] .349
Mean Difference (Net) [4] 3.473
Standard Error of the mean ± 2.162
95% Confidence Interval ( -1.942 to 8.888 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the escitalopram group.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The significance level was adjusted using a Bonferroni correction.
[4] Other relevant estimation information:
  The pramipexole group had a lower MADRS score than the escitalopram group.




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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.  


Results Point of Contact:  
Name/Title: Dr. Carlos A. Zarate
Organization: NIMH
phone: 301-451-0861
e-mail: zaratec@mail.nih.gov


Publications:


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
Study First Received: June 29, 2004
Results First Received: June 7, 2012
Last Updated: January 11, 2013
Health Authority: United States: Federal Government