Pamlab LLC Study Shows Combining L-methylfolate With an Antidepressant at the Start of Treatment Significantly Improves Depression Symptoms
5/25/2010 8:06:12 AM
NEW ORLEANS, May 24 /PRNewswire/ -- New data presented today at the American Psychiatric Association's annual meeting suggests a benefit to combining L-methylfolate, a prescription medical food called Deplin®, with an antidepressant at the start of treatment. This retrospective analysis showed a significantly greater improvement in depression symptoms in a shorter period of time, when patients with Major Depressive Disorder (MDD) were started on combination therapy. The retrospective study compared patients taking L-methylfolate with either a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI) versus patients who were only prescribed an SSRI or SNRI.
"We know from studies that nearly 70% of depressed individuals will not reach remission by taking one antidepressant alone, so clearly a new approach is needed," explained the study's principal investigator, Lawrence D. Ginsberg, M.D. of Red Oak Psychiatry, Houston, Texas. "Adding L-methylfolate to an antidepressant at the start of treatment has valuable benefits for these patients."
The study demonstrated that:
- 2.5 times more patients achieved major improvements in their depressive symptoms, functionality and behavior on combination therapy than on antidepressant monotherapy.
- Patients on combination therapy experienced 23% more rapid improvement than those taking antidepressant monotherapy (p=0.03). The more rapid time to major improvement demonstrated in the combination group was sustained throughout the study period (approximately two years).
- By 60 days, patients on combination therapy had already experienced a significant improvement (p=0.011) in their CGI scores compared to those on antidepressant monotherapy.
- Discontinuation rates due to adverse events were significantly lower in the combination group (17.9%) versus the antidepressant monotherapy group (34%) (p=0.0078), even though the overall rates of adverse events in both groups were not statistically different.
The primary outcome measure used in the study was a two point decline in the Clinical Global Impression-Severity (CGI-S) score, a seven point scale developed by the National Institute of Mental Health. The CGI-S score is a clinician-determined measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.
"We found that starting patients with a combination of L-methylfolate and an antidepressant was a much more time-efficient approach to help patients get better," explained Dr. Ginsberg. "Even with an aggressive endpoint, looking for a clinically relevant reduction in symptoms, we found that not only did patients on combination therapy experience a significant improvement in symptom severity but they were able to get better faster and with sustained improvement."
About the Study
Researchers performed a retrospective two-arm chart review of 242 adults, ages 18-70, with a primary diagnosis of MDD (single or recurrent), a CGI-S score of four (moderately ill) or five (markedly ill) and were experiencing some degree of functional impairment. Charts of eligible patients were divided into a combination group (SSRI or SNRI in combination with L-methylfolate 7.5-15 mg at treatment initiation; n=95) or a control arm (SSRI or SNRI monotherapy at treatment onset; n=147). Data were recorded on patient characteristics, including pre-treatment versus treatment scores using the CGI-S scale.
Deplin is a prescription medical food for the dietary management of suboptimal L-methylfolate levels in patients with depression. Up to 70 percent of people who suffer from depression may have a specific genetic factor that compromises their ability to convert folic acid into L-methylfolate. L-methylfolate is the only form of folate that can cross the blood brain barrier and regulate serotonin, norepinephrine and dopamine, the neurotransmitters associated with mood.
Founded in 1957, Pamlab is a fully integrated pharmaceutical company, with approximately 300 employees, specializing in prescription medical foods. Pamlab's products are marketed and sold nationally, helping hundreds of thousands of patients with depression, diabetic peripheral neuropathy, dementia, high-risk pregnancy and other diseases and conditions. For more information, please visit www.pamlab.com.
Each year, nearly 10 percent of the population, or more than 20 million American adults, will struggle with depressive illness. MDD is a recurring and chronic illness, frequently returning for two or more episodes, with episodes that often last two years or more. Researchers estimate that by the year 2020, depression will be the second leading cause of disability worldwide.