Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT00231959
Eligibility Criteria:
Inclusion Criteria:
* Meets diagnostic criteria for major depressive disorder
* Meets criteria for current major depressive episode
* Score of at least 18 on the Montgomery-Asberg Depression Rating Scale (MADRS) at the baseline visit
* Currently being treated with antidepressant monotherapy at an adequate dose for 6 weeks or willing to enter open lead-in treatment
* Agrees to use an effective form of contraception throughout the study
Exclusion Criteria:
* Pregnant
* At risk for suicide or homicide
* Unstable medical illness (e.g., cardiovascular, liver, kidney, respiratory, endocrine, or neurologic disease, including uncontrolled seizure disorder)
* History of a substance use disorder within 6 months of study enrollment
* History of or current psychotic features
* Currently being treated with typical or atypical antipsychotic medications
* Currently being treated with a medication known to significantly decrease pramipexole clearance (e.g., cimetidine, ranitidine, diltazem, verapamil, quinine or triamterene)
* Clinical or laboratory evidence of untreated hypothyroidism
* History of a 2-week or longer course of pramipexole
* Intolerance of pramipexole at any dose
* Any investigational psychotropic drug use within the last three months
* Level 3 or greater antidepressant resistance as assessed by the ATHF
* Three or more episodes of self-harm in the year prior to study enrollment
* Documented history of poor treatment adherence or frequently missed appointments
* Parkinson's disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00231959
Study Brief:
Protocol Section:
NCT00231959