Significant Benefit
In the TRD-1 study, 148 patients were randomized in a 2:3:3 design to receive either L-methylfolate for 60 days (7.5 mg/d in phase 1 and 15 mg/d in phase 2), placebo for 30 days followed by L-methylfolate for 30 days (7.5 mg/d), or placebo for 60 days.
The 75-patient TRD-2 was identical in design to TRD-1 except for a target dose of 15 mg/d of L-methylfolate throughout both phases.
The coprimary endpoints for both studies were the differences in response rates and in degree of improvement in the Hamilton Depression Rating Scale (HDRS-17) between treatment groups. An HDRS-17 response was defined asa 50% or greater reduction in HDRS-17 scale scores during treatment or a final score of 7 or less.
The TRD-1 study found no difference in outcome between the treatment groups.
The TRD-2 study showed greater efficacy for adjunctive 15 mg/d of L-methylfolate administered for up to 30 days vs placebo when added to continued SSRI therapy plus placebo on both primary outcome measures (degree of change and response rates according to the HDRS, P = .05 and .04, respectively).
There was no difference in the rates of treatment withdrawal due to adverse events in the L-methylfolate 15 mg/d/antidepressant and the placebo/antidepressant groups.
Finally, the number of patients needed to treat (NNT) for a response in the TRD-2 study was between 5 and 6 patients in favor of adjunctive 15 mg/dof L-methylfolate vs placebo. "This is on a par with NNTs reported for other augmentation strategies in MDD," Dr. Papakostas said.
Adjunctive L-Methylfolate May Help in Treatment-Resistant Depression
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