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IRCT20120520009801N6 IRCT 2021-11-02 Mashhad University of Medical Sciences The effect of dextromethorphan on the severity of symptoms in patients with resistant OCD The effect of dextromethorphan on the severity of symptoms in patients with resistant obsessive-compulsive disorder: A triple blinded, randomized clinical trial 2022-04-19 anticipated 75 Complete https://irct.ir/trial/59650 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2 obsessive-compulsive disorder. Intervention 1: Patients are selected from outpatients who visit the clinic of EbneSina Hospital. In the intervention group, patients diagnosed with obsessive-compulsive disorder, who meet the inclusion and exclusion criteria, will randomly add one of the following 3 interventions to their high-dose (SSRI) regimen. (This study will be performed on patients with obsessive-compulsive disorder who have been on high doses of SSRI for at least 8 weeks but have a Y-BOCS index score higher than 10) The severity of symptoms of obsessive-compulsive disorder will be assessed using the Yale Brown Obsessive-Compulsive Disorder Scale before intervention and 1 month, 2 months and 3 months after intervention. The Delis-Kaplan Executive Performance Test (D-KEFS) will be evaluated before the intervention and 3 months after the intervention. adverse effect was evaluated through study and each month of drug consumption. Intervention group1: high dose of SSRI + dextromethorphan (60 mg/day) (High doses of SSRIs include sertraline: maximum 200mg / day, paroxetine: maximum 60mg / day, fluoxetine: maximum 80mg / day, fluvoxamine: maximum 300mg / day) The main medication, Dextromethorphan, is purchased from Pursina pharmaceutical company. Intervention 2: Intervention group: high dose of SSRI + memantine (20 mg/day) (High doses of SSRIs include sertraline: maximum 200mg / day, paroxetine: maximum 60mg / day, fluoxetine: maximum 80mg / day, fluvoxamine: maximum 300mg / day). Intervention 3: third group: high dose of SSRI + placebo The placebo tablet contains all the ingredients of the main pill and only lacks the active ingredient dextromethorphan and memantine, and will receive 1 tablets a day for 3 months in addition to the standard treatment regimen for obsessive-compulsive patients. The placebo tablet, which is similar to the main medication in terms of shape and color is made in Mashhad School of Pharmacy in accordance with the principles of GLP. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: starting 6 months after publication To whom: only available for people working in academic institutions Conditions: only available for people working in academic institutions and there is not another condition Where to obtain: mohamadpoorah@mums.ac.ir How to obtain: mohamadpoorah@mums.ac.ir Comments:
public Mohammadpour Amir Hooshang
School of Pharmacy, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 1882 3255 mohamadpoorah@mums.ac.ir Mashhad University of Medical Sciences scientific Amir Hooshang Mohammadpour
School of Pharmacy, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 1882 3255 mohamadpoorah@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 includ: Sertraline 200mg/day, Paroxetine 60mg/day, Fluoxetine 80mg/day and Fluvoxamine mg/day) subjects aged 18 to 60 years Obtaining the patient's informed consent 18 years 60 years Both Pregnancy or breastfeeding Using serotonergic drugs other than SSRIs Use of NMDA receptor antagonists other than dextromethorphan and memantine Psychotic and bipolar disorders (based on DSM-5 criteria) past medical history of Liver dysfunction (LFT> 3ULN) past medical history of Kidney dysfunction (GFR <60 ml / kg / min) past medical history of Thyroid Disorders History of seizures F42 Obsessive-compulsive disorder Treatment - Drugs Treatment - Drugs Treatment - Drugs Patients are selected from outpatients who visit the clinic of EbneSina Hospital. In the intervention group, patients diagnosed with obsessive-compulsive disorder, who meet the inclusion and exclusion criteria, will randomly add one of the following 3 interventions to their high-dose (SSRI) regimen. (This study will be performed on patients with obsessive-compulsive disorder who have been on high doses of SSRI for at least 8 weeks but have a Y-BOCS index score higher than 10) The severity of symptoms of obsessive-compulsive disorder will be assessed using the Yale Brown Obsessive-Compulsive Disorder Scale before intervention and 1 month, 2 months and 3 months after intervention. The Delis-Kaplan Executive Performance Test (D-KEFS) will be evaluated before the intervention and 3 months after the intervention. adverse effect was evaluated through study and each month of drug consumption. Intervention group1: high dose of SSRI + dextromethorphan (60 mg/day) (High doses of SSRIs include sertraline: maximum 200mg / day, paroxetine: maximum 60mg / day, fluoxetine: maximum 80mg / day, fluvoxamine: maximum 300mg / day) The main medication, Dextromethorphan, is purchased from Pursina pharmaceutical company. Intervention group: high dose of SSRI + memantine (20 mg/day) (High doses of SSRIs include sertraline: maximum 200mg / day, paroxetine: maximum 60mg / day, fluoxetine: maximum 80mg / day, fluvoxamine: maximum 300mg / day) third group: high dose of SSRI + placebo The placebo tablet contains all the ingredients of the main pill and only lacks the active ingredient dextromethorphan and memantine, and will receive 1 tablets a day for 3 months in addition to the standard treatment regimen for obsessive-compulsive patients. The placebo tablet, which is similar to the main medication in terms of shape and color is made in Mashhad School of Pharmacy in accordance with the principles of GLP. Evaluation of the effect of dextromethorphan in comparison with placebo on reducing the severity of symptoms in patients with obsessive-compulsive disorder based on (Y-BOCS) YALE-BROWN OBSESSIVE COMPULSIVE SCALE. Timepoint: Before intervention and 1 month, 2 months and 3 months after intervention. Method of measurement: Yale–Brown Obsessive Compulsive Scale. Comparison of changes in executive functions in different groups. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Delis-Kaplan Executive Function System (D-KEFS) tests. Adverse effect of drugs. Timepoint: In the first, second, and third months of using the medication, and whenever the patient experienced a complication, there was the possibility of contacting the clinical pharmacist who was aware of the types of codes.(However, she did not participate in any of the randomization, drug administration, or data analysis processes.). Method of measurement: patients declaration. Mashhad University of Medical Sciences Approved 2021-10-23 Mashhad University of Medical Sciences Ethic committee of Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)