Opioid Receptor Antagonism Attenuates Antidepressant Effects of Ketamine methods
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In a proposed double-blind, cross-over study of 30 adults with treatment-resistant depression, we performed a planned interim analysis after studying 14 participants, 12 of whom completed both conditions in randomized order: 50mg naltrexone preceding 0.5mg/kg ketamine or placebo preceding 0.5mg/kg ketamine.
Methods
Potential study participants were brought into the clinic for a screening visit to determine eligibility. All study participants were outpatients. Inclusion criteria included a current diagnosis of a non-psychotic, non-atypical major depressive episode as part of either bipolar II disorder or major depressive disorder, defined by DSM-5 criteria ( ). For the initial enrollment, all participants were required to have a score ≥20 on the 17-item Hamilton Depression Rating Scale ( ). Each participant was also required to have not benefited sufficiently from trials of at least 4 different antidepressant medications or other somatic treatments as defined by the Massachusetts General Hospital Antidepressant Treatment History Questionnaire criteria ( ), as well as a minimum of 6 weeks of prior psychotherapy during any major depressive episode prior to intervention.
Methods
All eligible participants provided full written informed consent. The study protocol was approved by the Stanford University Institutional Review Board. All participants were required to hold any stimulant/amphetamine drugs documented during the screening phase for the 24 hours prior to ketamine administration and could resume these medications Day 1 post-infusion after the completion of the ratings. Participants were required to withhold taking any benzodiazepine for the 8 hours prior to (or any hypnotic drugs the night prior to) ketamine administration and could resume these medications Day 1 post-infusion after the completion of the ratings. Furthermore, any medical marijuana use was held for two weeks in order to allow for proper washout prior to the baseline/randomization visit (e.g., at least 5 half-lives of the drug). We excluded individuals on opiates in order to avoid naltrex...
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Evidence quotes (3)
In a proposed double-blind, cross-over study of 30 adults with treatment-resistant depression, we performed a planned interim analysis after studying 14 participants, 12 of whom completed both conditions in randomized order: 50mg naltrexone preceding 0.5mg/kg ketamine or placebo preceding 0.5mg/kg ketamine.
Potential study participants were brought into the clinic for a screening visit to determine eligibility. All study participants were outpatients. Inclusion criteria included a current diagnosis of a non-psychotic, non-atypical major depressive episode as part of either bipolar II disorder or major depressive disorder, defined by DSM-5 criteria ( ). For the initial enrollment, all participants were required to have a score ≥20 on the 17-item Hamilton Depression Rating Scale ( ). Each participant was also required to have not benefited sufficiently from trials of at least 4 different antidepressant medications or other somatic treatments as defined by the Massachusetts General Hospital Antidepressant Treatment History Questionnaire criteria ( ), as well as a minimum of 6 weeks of prior psychotherapy during any major depressive episode prior to intervention.
All eligible participants provided full written informed consent. The study protocol was approved by the Stanford University Institutional Review Board. All participants were required to hold any stimulant/amphetamine drugs documented during the screening phase for the 24 hours prior to ketamine administration and could resume these medications Day 1 post-infusion after the completion of the ratings. Participants were required to withhold taking any benzodiazepine for the 8 hours prior to (or any hypnotic drugs the night prior to) ketamine administration and could resume these medications Day 1 post-infusion after the completion of the ratings. Furthermore, any medical marijuana use was held for two weeks in order to allow for proper washout prior to the baseline/randomization visit (e.g., at least 5 half-lives of the drug). We excluded individuals on opiates in order to avoid naltrexone precipitating opioid withdrawal along with eliminating the confound of ketamine-opioid interactions. If a washout period was necessary prior to study participation, the study physician maintained ongoing contact with the participant to ensure safety during this time. Those medications deemed lik...
Machine-readable layer
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