The effect of dextromethorphan on the severity of symptoms in patients with resistant obsessive-compulsive disorder: A triple blinded, randomized clinical trial

Comparison of the effects of dextromethorphan (60 mg / day) against placebo on the severity of symptoms by measuring the Yale-Brown Obsseive-Compulsive Scale in patients with obsessive-compulsive disorder

A randomized clinical trial, on 48 patients, block randomization (via randomization site), parallel groups, triple-blind, phase 2.

This is a randomized triple-blind study.This study had been performed on 48 patients with obsessive-compulsive disorder, who had been referred to outpatient clinical of EbneSina Hospital. Patients had been evaluated separately by a psychiatrist. The severity of obsessive-compulsive disorder in these patients had been assessed at the beginning of the study by interviewing a psychiatrist using the Yale Brown Obsessive-Compulsive Disorder (Y-BOCS) scale , who met the inclusion and exclusion criteria, was enter the study after obtaining informed consent.The results of the psychiatrist's interview with the patient and the evaluation of (Y-BOCS) scale had been recorded in a special questionnaire for each patient at the beginning of the study (before the intervention) and 1 month, 2 months and 3 months after the intervention.

1)OCD patients who have been treated with high doses of SSRI for at least 8 weeks but have a Y-BOCS index score higher than 10. (High doses of SSRI include: Sertraline 200mg/day, Paroxetine 60mg/day, Fluoxetine 80mg/day and Fluvoxamine mg/day) 2)subjects aged 18 to 60 years 3) Obtaining the patient's informed consent

group1: high dose of SSRI + placebo group. group2: high dose of SSRI + dextromethorphan (60 mg/day) group3: high dose of SSRI + memantine (20 mg/day)

(Y-BOCS) YALE-BROWN OBSESSIVE COMPULSIVE SCALE

patients intolerance

To facilitate the random assignment of individuals to study groups, a permutation block method was employed, utilizing blocks of sizes 3 and 6. Randomization and allocation concealment were performed in accordance with CONSORT recommendations. A computer-generated randomization list was created using a web-based randomization service www.sealedenvelope.com, which was prepared by an independent statistician not involved in patient recruitment or outcome assessment. Based on this list, study medications were packaged into identical, opaque, sequentially numbered boxes corresponding to allocation codes A, B, and C. The boxes were indistinguishable in external appearance, and only the code number was visible to the recruiting clinicians. At the time of enrollment, each participant received the next available box in numerical order, ensuring that the treatment assignment remained concealed from investigators and participants until the end of the study or until unblinding was required for safety reasons

As our data are collected step by step and patients are gradually included in the study, concerning the time of inclusion and at the beginning of inclusion according to the sequence obtained in the randomization stage, after evaluating inclusion criteria, the patients will be assigned to either control groups or interventions groups by physician. These codes are provided to the physician's office. It is worth mentioning that clinical pharmacy should be fully aware of the type of code. The clinical pharmacist is also provided with the medications in terms of the assigned number (C or B or A) and is fully aware of the fact that which medication is Dextromethorphan or Memantine or placebo, as well. (This clinical pharmacist is engaged neither in prescribing and evaluating the treatments, nor in analyzing data, and is exclusively responsible for maintaining codes and delivering medications to the patients based on a random code allocated by the physician.) The assigned code is recorded in the CRF form. After taking either the medication or placebo for three months by the patients, in the clinic of Ebn-e-Sina Hospital, the patients are appraised by a physician who has no idea which drug the patients have received and is only aware of the assigned codes and then carries out the appropriate evaluations. After documentation, the results in the form of codes are provided to the person who performs the data analysis. The data analysis is performed while the data analyzer has no information about the type of the taken medication, and all confidential information is recorded and stored without mentioning the patient's name

all collected deidentified IPD

starting 6 months after publication

only available for people working in academic institutions

only available for people working in academic institutions and there is not another condition

mohamadpoorah@mums.ac.ir

mohamadpoorah@mums.ac.ir