Major Depressive Disorder Clinical Trial
Official title:
A Randomized Trial Comparing Efficacy and Tolerability of Levomilnacipran Switch Versus Adjunctive Quetiapine in Major Depressive Disorder (MDD) With Inadequate Response to SSRIs
This study's primary objective is to compare the efficacy and tolerability of switching
patients with inadequate relief on generic SSRIs to levomilnacipran versus adding a new
treatment (quetiapine) to the participants' existing treatment with people diagnosed with
depression (major depression disorder).
The secondary objective is to examine the response and remission rates following the switch
from a generic SSRI to levomilnacipran ER and augmentation with quetiapine along with
examining changes in neurocognitive and apathy measures after the switch.
1. Study Design 1) An 8-week, randomized rater blinded parallel group, 2-arm trial 2) Trial
duration - 9 weeks 3) Drug doses
- Levomilnacipran ER; Switching to a flexible dose regime of levomilnacipran ER
40-120 mg/day after initial dose of 20mg.
- Quetiapine XR; Adjunct a flexible dose regimen of quetiapine XR 150-300 mg/day
after initial dose of 50mg.
2. Objective 1) To compare the efficacy and tolerability of switching to levomilnacipran ER
(40-120 mg/d) versus augmentation with quetiapine XR 150-300 mg/day to the patients'
existing treatment for patients with inadequate relief on generic SSRIs in patients with
MDD.
2) To examine the response following the switch from generic SSRI to levomilnacipran ER and
augmentation with quetiapine XR.
3) To examine changes in neurocognitive and apathy measures after switching from SSRI to
levomilnacipran ER and after augmentation with quetiapine XR in MDD
;
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