Obsessive-compulsive disorder (OCD) is the fourth most common mental disorder in Bangladesh
and around the world. Selective serotonin reuptake inhibitors (SSRIs) are commonly
administered drugs for treating children and adolescents with OCD. The treatment of this
condition has remained unsatisfactory, only 40-60% of patients with OCD respond to SSRIs, and
about 40 to 60% of patients with OCD do not completely respond to this drug. Researchers
throughout the world are involved to obtain new pharmacotherapy for the treatment of OCD. A
good number of evidences have proved that oxidative stress plays a significant role in the
pathophysiology of OCD.Researches so far have indicated that free radical induced injuries
are involved in the pathology of OCD.Pyridoxine (Vit B6) is a water soluble vitamin, has anti
oxidant effects.Therefore the present study has been designed to assess the effects of
pyridoxine along with standard treatment upon OCD patients.
Aim: This proposed study is therefore an effort whether there is any role of Pyridoxine (vit
B6) adjuncts with standard treatment produce better improvement than standard treatment alone
in OCD patients. Method: This study will be a randomized, double-blind, placebo-controlled
trial that will be conducted in the department of pharmacology, BSMMU in collaboration with
the department of psychiatry, BSMMU, Dhaka from the day of approval by the IRB (Institutional
Review Board) to July 2024. A total of 76 patients suffering from OCD will be selected
according to inclusion and exclusion criteria. The diagnosis of patients suffering from OCD
and the selection of drug and dosage would be performed by a senior professor of the
psychiatry department. After completing the necessary formalities including informed consent
of the patients, the patient would undergo a selected questionnaire Yale-Brown Obsessive
Scale (Y-BOCS-10) to assess the severity of the disease. The patients would be randomly
allocated into two arms: control and intervention. Patients in the intervention arm would
consist of 38 patients who will receive standard treatment plus tab pyridoxine 25 mg twice
daily for 8 weeks. On the other hand, the control arm would consist of 38 patients who will
receive standard treatment plus a placebo for 8 weeks. The severity of symptoms will be
assessed after 8 weeks follow-up. Biochemical parameters of oxidative stress markers (RBC
glutathione, plasma MDA) will be measured at baseline and after 8 weeks.Along with the
biochemical parameters, Yale-Brown score of obsessive-compulsive disorders (Y-OCD) would also
be assessed by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at baseline and after 8 weeks.
The regularity of medicine intake will be ensured over the telephone and from the patient's
compliance sheet. Statistical analysis will be obtained by SPSS (statistical package for
social science) version 24. The calculated 'p' value may suggest the level of significance
(significant at p<0.05). Ethical consideration: After approval from IRB (Institutional Review
Board) every eligible patient will be informed about the intervention and the study
objectives. Patients will also be informed that they can participate or to withdraw at any
time without compromising their medical care. Patient confidentiality will be strictly
maintained. Patient's personal data regarding the name, age, sex, and other information will
not be disclosed anywhere and will be used only for research purposes.
