Status:
COMPLETED
Lexapro and Pramipexole and to Treat Major Depression
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Major Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study compares the effectiveness of the combination of antidepressants: Lexapro and Pramipexole, with the effectiveness of each antidepressant alone. Purpose: Patients between 18 and 65 years of...
Detailed Description
Despite the availability of a wide range of antidepressant drugs, 30% to 40% of patients with major depression fail to respond to first-line antidepressant (e.g., selective serotonin reuptake inhibito...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Male or female subjects, 18 to 65 years of age.
- Female subjects of childbearing potential must be using a medically accepted means of contraception.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- Subjects must fulfill DSM-IV criteria for Major Depression (296.33) without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview, SCID-P.
- Subjects must have an initial score of greater than or equal to 20 on the MADRS at Visit 1 and Visit 2.
- Subjects must not have a greater than a 25% decrease in the MADRS total scores during washout (between Visits 1 and 2).
- Current or past history of lack of response to at least one adequate antidepressant trial (SSRI) operationally defined using the Antidepressant Treatment History Form (ATHF) (Sackeim 2001b). If this criteria has not been met, a four-week prospective trial of a standard antidepressant (at the patients' and clinicians' discretion) may be given. Subjects are excluded if greater than four failed antidepressant trials for the current major depressive (adequate dose and duration as defined by the ATHF).
- Current major depressive episode of at least 4 weeks duration.
- EXCLUSION CRITERIA:
- Presence of psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder or bipolar disorder as defined in the DSM-IV.
- Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for nicotine or caffeine) within the preceding 3 months.
- Previously failed to respond to an adequate trial (dose and duration) of escitalopram.
- Female subjects who are either pregnant or nursing.
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Subjects with uncorrected hypothyroidism or hyperthyroidism.
- Subjects with one or more seizures without a clear and resolved etiology.
- Previous treatment with pramipexole.
- Treatment with a reversible MAOI within 2 weeks prior to Visit 2.
- Treatment with fluoxetine within 5 weeks prior to Visit 2.
- Treatment with any other concomitant medication not allowed (Appendix A) 7 days prior to study Visit 2.
- Treatment with clozapine or ECT within 3 months prior to study Visit 2.
- Judged clinically to be an acute suicidal risk.
- Psychotherapy will not be permitted during the study.
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00086307
Start Date
June 1 2004
End Date
March 1 2010
Last Update
January 28 2013
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892