Intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder: protocol for a randomized, double-blind, placebo-controlled pilot study

DiscussionIn our study, ATP and PCr will be given by intravenous infusion. Thus patients will be hospitalized for the initial 2  weeks for safety concern. Hospitalization will be an impact factor for the recruitment, participation, drop-out, efficacy, results, etc. The evaluation of our feasibility outcomes, study setting, safety of augmentation therapy and possible efficacy trends among groups, will facilitate a full-scal e trial design and sample size calculation.Trial registrationNCT03138681. Registered on 3 May 2017. First patient: 4 May 2017.

Source: Trials - January 9, 2019 Category: Research Source Type: clinical trials