Post-traumatic stress state
Conditions
Interventions
Randomized, double-blind, crossover, placebo-controlled clinical trial to evaluate the efficacy of esketamine in augmenting standard treatment of post-traumatic stress disorder. 35 patients aged 18 to
that is, those who previously used esketamine are switched to receive placebo, and those who received placebo are switched to esketamine. During the infusions, pulse oximetry (measurement of oxygen in
Sponsors
Universidade Federal da Bahia
Hospital Universitário Professor Edgard Santos
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Male or female, eighteen to sixty-five years old. Level of understanding sufficient to agree to the necessary tests and exams and sign the Free and Informed Consent Form. Fulfill the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, for the diagnosis of post-traumatic stress disorder, from the structured diagnostic interview The Mini International Neuropsychiatric Interview. Initial score of at least fifty points on the Clinician-Administered Post Traumatic Stress Disorder Scale. A woman of childbearing age who agrees to use contraceptive methods or to commit to abstaining from sexual activity in order not to become pregnant during the study
Exclusion criteria
Exclusion criteria: Diagnosis of bipolar disorder and schizophrenia or any other psychotic disorder. Current diagnosis of bulimia or anorexia nervosa. Individuals with a history of alcohol or drug use disorder (other than nicotine or caffeine) within the last 3 months and must have a negative alcohol and drug test at screening. Women who are pregnant or breastfeeding. Serious and unstable clinical diseases. History of seizures without a clear and resolved etiology. Treatment with a monoamine oxidase inhibitor within 4 weeks prior to the study. Treatment with any other concomitant medication that may interfere with the outcome assessment or participant safety (benzodiazepines, scopolamine, antihistamines, psilocybin, methamphetamines, propranolol). In case of use of a benzodiazepine for the treatment of insomnia, the dose should be reduced, use a non-benzodiazepine hypnotic and wait three half-lives for entry into the study. Presence of any clinical disease that may alter the morphology and/or physiology of the brain. Clinically significant abnormal laboratory tests. Investigators or their immediate family members. Active suicide risk. Severe depression (score greater than 28 on the Montgomery-Asberg Depression Scale). Patients who, after randomization, need to change the standard treatment with drug withdrawal or inclusion of new ones in their treatment regimen for post-traumatic stress disorder should be excluded from the study to minimize potential biases caused by differences between groups. The last addition, change, or dose increase of antidepressant should be 30 days apart before randomization. Women of childbearing age who do not use contraceptive methods or do not abstain from sexual activity or become pregnant during the study will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare between the control and placebo groups of changes in post-traumatic stress disorder symptoms measured from the change in the Impact of Event Scale–Revised total score between the pre-drug assessment and the assessment 24 hours after application. We will use as a method a linear mixed model of fixed effects using the Impact of Event Scale – Revised scores as the dependent variable, time (representing the different moments), treatment and their interaction as fixed effects and individuals as random effects. Main effects will be analyzed using the F statistic, and post hoc paired analyzes will be conducted with Tukey correction for multiple comparisons. The constrained maximum likelihood estimate will be used to analyze incomplete data. Significant effects will be examined with simple effects tests. The primary analysis will follow the intent-to-treat principle. Significance is assessed at P < 0.05, two-tailed. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the changes in post-traumatic stress disorder symptoms measured from the variation in the total score of the Impact of Event Scale– Revised scale, between the assessment before drug administration and the assessment 48 hours after application. We will use the method described for the primary outcome.;Evaluate the changes in symptoms of post-traumatic stress disorder measured from the variation in the total score of the Impact of Event Scale– Revised scale, between the assessment before drug administration and the assessment 72 hours after application. We will use the method described for the primary outcome.;Evaluate the changes in symptoms of post-traumatic stress disorder measured from the variation in the total score of the Impact of Event Scale– Revised scale, between the evaluation before drug administration and the evaluation 7 days after application. We will use the method described for the primary outcome.;To compare the proportion of responders (subjects who achieved a reduction of at least 50% of symptoms by the Impact of Event Scale–Revised scale) of the control group and placebo after 24 hours of application. We will use as a method to compare the proportions of the placebo and control groups using Pearson's chi-square test or Fisher's exact test for proportions. Differences will be accepted using a 95% confidence interval, in a one-sided test.;Evaluate the changes in symptoms from the variation in the total score of the Clinical Global Impression–Severity, Clinical Global Impression–Improvemen, Patient Global Impression of Severity, Patient Global Impression of Change, and Montgomery-Asberg depression scale scales between assessment before application of drugs and evaluations for days 2, 3, 4, 7 and 14 after application. We will use the method described for the primary outcome.;To assess changes in post-traumatic stress disorder symptom clusters (intrusion, avoidance, excitability and reactivity, negative mood, and cognition) measured from t | — |
Countries
Brazil
Contacts
Public ContactLucas Quarantini
Hospital Universitário Professor Edgard Santos
Outcome results
None listed