Investigating the effectiveness of adding famotidine and vitamin B6 to standard drug treatment in reducing negative symptoms in patients with schizophrenia disorder: a clinical trial with a control group

Determine effectiveness of adding famotidine and vitamin B6 to standard pharmaceutical treatment in patients with schizophrenia disorder

Clinical trials with control group, parallel groups, double-blind, randomized, phase 3, on 80 patients, Randomization was centralized and computerized with concealed randomization sequence carried out at an external site.

This study is a double-blind trial. The study sample population is consists of all male and female with schizophrenia disorder referring to Farabi Hospital in Kermanshah, that 80 persons will be selected in the available method and randomly will be divided into two groups. Pills will be given to patients without awareness of the patient and the examiner, and the code for each drug will be recorded in the patient's questionnaire. All subjects in all two groups will be re-evaluated by completing questionnaires at baseline, 6 weeks and the end of the study (12 weeks after baseline), will be assessed.

Inclusion criteria: Both genders; Schizophrenia Disorder diagnoses with negative symptoms according to Diagnostic and Statistical Manual of Mental Disorders fifth edition by a psychiatrist; under treatment with aripiprazole. Non-inclusion criteria: Patients who are not agree to participate in the study

Intervention group: The group will receive the combination of famotidine/vitamin B6 tablets in 12 weeks, along with the standard drug treatment (aripiprazole). The daily dose will be 1 pill of 190 mg (famotidine, 40 mg and vitamin B6, 150 mg). These pills will be given to patients without awareness of the patient and the examiner, and the code for each drug will be recorded in the patient's questionnaire. Famotidine/vitamin B6 pills will be purchased from Caspin Daru Pharmaceutical Company.

Severity of negative symptoms

Patients will be divided into two equal groups (A and B) based on a randomized size 8-block design using random allocation software. To randomly assign 80 patients to the intervention and control groups, 8 different blocks of 10 different letters A and B, which indicate Famotidine/vitamin B6 and placebo groups respectively, will be initially created. These blocks will be numbered from one to eight. In the next step, each of these blocks will be randomly selected by performing lottery using 8 cards with numbers 1 to 8 on them. Thus, in each lottery, by selecting a block, a combination of 10 letters of the letters A (Famotidine/vitamin B6 group) and B (placebo group) will be obtained. At the end of the 8 drawings, after selecting 8 blocks, a total of 80 letters A and B will be obtained. The resulting combination of letters A and B is single, and will be placed in 80 separate and sealed envelopes, respectively. Following each patient recourse, an envelope will be opened to determine the group of that patient.

The medication and placebo are delivered to the patient without sticking the name of the medication. The doctor is also unaware of the type of drug used in each group. The color and smell of the main drug and placebo are the same.