Status:
COMPLETED
Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis
Lead Sponsor:
Pamlab, Inc.
Collaborating Sponsors:
Red Oak Psychiatry Associates, PA
Baylor Health Care System
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Brief Summary
This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with an antidepressant is better than an antidepressant alone in adults with major depression.
Eligibility Criteria
Inclusion
- Males or females age 18-70
- The active arm (Arm #1) includes randomly selected 100-125 charts of patients with a primary diagnosis of major depression and a CGI-S of ≥4 who began Deplin and SSRI or SNRI therapy at the same time beginning in January 2007 to the present; and, Control group (Arm #2) includes randomly selected 125-150 charts of patients with a primary diagnosis of major depression who began SSRI or SNRI therapy matched in severity (CGI-S of ≥4)
Exclusion
- Folic acid \>400 mcg taken at any time during the study
- Psychotic features in the current episode or a history of psychotic features
- Any bipolar disorder (current or past) or any psychotic disorder (current or past)
- Current or past treatment with vagus nerve stimulation, ECT, or transcranial magnetic stimulation
- Antipsychotic therapy in conjunction with their antidepressant currently or in past 4 weeks
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT01001559
Start Date
August 1 2009
End Date
June 1 2011
Last Update
December 19 2013
Active Locations (1)
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1
Red Oak Psychiatry Associates, PA
Houston, Texas, United States