MedDataX Logo

Effect of N-acetylcysteine as Add on Therapy With SSRI in Moderate to Severe OCD Patients

NCT ID: NCT04904952

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-13

Study Completion Date

2022-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Title:

Effect of n-acetylcysteine as add-on therapy with Selective Serotonin Reuptake Inhibitors in moderate to severe Obsessive Compulsive Disorder patients.

Purpose of the study:

To assess the effects of the addition of n-acetylcysteine with SSRIs on the severity of symptoms in obsessive-compulsive disorder patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 glutamate plays a significant role in the pathophysiology of OCD.N-acetylcysteine (NAC) is an amino acid derivative, is a health supplement, and has neuroprotective effects that target the glutamatergic system. Some recent trials attempted to assess the effect of n-acetylcysteine as an add-on therapy with SSRIs to improve symptoms in OCD patients. Aim: This proposed study is therefore an effort whether there is any role of n-acetylcysteine adjuncts with SSRI produce better improvement than SSRI alone in OCD patients. Method: This study will be a randomized, double-blind, placebo-controlled multicenter trial that will be conducted in the department of pharmacology, BSMMU in collaboration with the department of psychiatry, BSMMU, and Combined Military Hospital (CMH), Dhaka from the day of approval by the IRB to January 2022. A total of 56 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 30 patients who will receive SSRIs plus NAC. NAC was titrated from 600mg/day and doubling weekly to reach a maximum dose of 2400mg/day (at week-3) for the remaining 7 weeks. On the other hand, the control arm would consist of 30 patients who will receive SSRIs plus a placebo for 10 weeks. The severity of symptoms will be assessed after 4 weeks and 10 weeks follow-up. The brain glutamate level, ALT, AST, serum creatinine, and ECG will be measured at baseline and after 10 weeks. The regularity of medicine intake will be ensured over the telephone, pill count, and from the patient's compliance sheet. Statistical analysis will be obtained by SPSS (statistical package for social science) version 24. Paire't' test will be done to compare between two means of before and after the intervention. Proportion test 'Z' will be done to compare the proportion between the intervention group and the placebo group. The calculated 'p' value may suggest the level of significance (significant at p\<0.05). Ethical consideration: After approval from IRB 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

OCD

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

N-acetylcysteine, OCD, MRS, Glutamate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

This arm includes 30 OCD patients receiving SSRIs

Group Type ACTIVE_COMPARATOR

N-acetylcysteine tablet 600mg

Intervention Type DRUG

N-acetylcysteine tablet 600mg/day and doubling weekly to reach a maximum dose of 2400mg/day (at week-3) for remaining 7 weeks along with SSRIs

Control

This arm includes 30 OCD patients receiving SSRIs

Group Type PLACEBO_COMPARATOR

Placebo tablet 600mg

Intervention Type DRUG

Placebo tablet 600mg/day and doubling weekly to reach a maximum dose of 2400mg/day (at week-3) for remaining 7 weeks along with SSRIs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N-acetylcysteine tablet 600mg

N-acetylcysteine tablet 600mg/day and doubling weekly to reach a maximum dose of 2400mg/day (at week-3) for remaining 7 weeks along with SSRIs

Intervention Type DRUG

Placebo tablet 600mg

Placebo tablet 600mg/day and doubling weekly to reach a maximum dose of 2400mg/day (at week-3) for remaining 7 weeks along with SSRIs

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Newly diagnosed OCD patients diagnosed by Psychiatric Consultant of the Department of Psychiatry according to DSM-5 criteria (Appendix VI).
* Moderate to severe OCD patients having AY-BOCS score \> 16
* Age: 18 years or above
* Sex: Both male and female

Exclusion Criteria

Patients receiving antidepressant within last two months.

* Patients having any history of psychiatric and medical conditions will be excluded from the study.
* Patients having suicidal thoughts.
* Pregnancy and lactation.
* Patients who are receiving psychotherapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sadia Binte Anwar Sonia

MD, Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Prof Md. Sayedur Rahman, MBBS, M.Phil

Role: STUDY_CHAIR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

BSMMU

Dhaka, , Bangladesh

Site Status RECRUITING

Sadia Binte Anwar Sonia

Dhaka, , Bangladesh

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Bangladesh

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sadia Binte Anwar Sonia, MBBS

Role: CONTACT

Phone: 01752093329

Email: [email protected]

Prof Md. Sayedur Rahman, MBBS,M.Phil

Role: CONTACT

Phone: 01971840757

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sadia Binte Anwar Sonia, MBBS

Role: primary

Prof Md. Sayedur Rahman, MBBS,M.Phil

Role: backup

Sadia Binte Anwar Sonia, MBBS

Role: primary

Prof Md. Sayedur Rahman, MBBS.Mphil

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BSMMU/2021/2300

Identifier Type: -

Identifier Source: org_study_id