Dextromethorphan augmentation therapy for moderate-to-severe obsessive–compulsive disorder: randomized, double-blind,placebo-controlled trial

Effect of dextromethorphan as an augmentation therapy in obsessive-compulsive disorder patients without adequate response to drug treatment

randomized, blinded, controlled clinical trial with a parallel group design of 54 patients.Randomization with binomial distribution

A number of 54 patients are selected from the patients who meet the conditions for entering the study. Before the start of the study, the statistician selects the patients by randomization for two groups A and B. Dextromethorphan drug And the placebo is placed in the same boxes with the code and given to the patients based on the codes.The patient, clinician, researcher, and data analyst will be blinded.

Inclusion criteria include patients over 18 years of age who have been diagnosed with moderate-to-high obsessive-compulsive disorder (YBOCS>16) and have not responded to 12 weeks of obsessive-compulsive disorder treatment with an adequate dose of an SSRI drug, and also filled out an informed consent form; The conditions of non-entry include patients who have comorbidity with other psychiatric disorders except major depressive disorder, such as psychotic disorders, drug-related disorders, and also have severe kidney and liver disease, unstable medical conditions, or pregnancy ,are is.

In the intervention group, one tablet of dextromethorphan with a dose of 15 mg BID daily is given orally along with the previously used SSRI drug for 90 days from Dana Pharmaceutical Company. In the control group, similar tablets, which is prepared by the pharmacy of Shahid Dr. Beheshti Hospital,is given orally BID daily along with the previously used SSRI drug for 90 days.

Severity of Obsessive Compulsive Disorder based on Obsessive Compulsive Scale (Y-BOCS)

In order to assign patients to two intervention and control groups, before the start of the study, the statistician determines the treatment group of the patients in the order of entering the study by generating random data with a binomial distribution with a probability of 0.5, and the patients are divided into two groups in the order of entering the study. A and B are entered. In this way, the researcher has no involvement in allocating the type of treatment. The outcome assessor and the clinician will not be aware of the randomization procedure.

In order to assign patients to two intervention and control groups, before the start of the study, the statistician determines the treatment group of the patients in the order of entering the study by generating random data with a binomial distribution with a probability of 0.5, and the patients are divided into two groups in the order of entering the study. A and B are entered. According to the number of patients studied, dextromethorphan and placebo drugs, which are completely similar in terms of shape and size, are placed in similar boxes and the boxes are coded. Codes related to the drug and the placebo will be done by someone other than the researcher and clinician, and the patient, clinical caregiver, researcher, data collector, and data analyst will not know about it. will be given to patients.

Data may be published after de-identifying individuals.

When publishing the results

Researchers working in academic and scientific institutions

For scientific research

Library of Zanjan University of Medical Sciences

Refer to the university library