Effect of N-acetylcysteine as Add on Therapy With SSRI in Moderate to Severe OCD Patients
1 other identifier
interventional
60
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2020
CompletedFirst Submitted
Initial submission to the registry
May 23, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2022
CompletedNovember 16, 2021
November 1, 2021
1.8 years
May 23, 2021
November 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OCD severity score assessment
Assess the severity score of OCD symptoms by YBOCS-10 at baseline, after 4 weeks, and after10 weeks. And compare the score between two groups. YBOCS-10 range from 0-40 with the following scores: 0-14 Non significant to mild, 15-23 Mild to moderate, 23-29 Moderate to severe, 30-40 Severe to disabling.
10 weeks
Secondary Outcomes (1)
Neurochemical assessment
10 weeks
Study Arms (2)
Experimental
ACTIVE COMPARATORThis arm includes 30 OCD patients receiving SSRIs
Control
PLACEBO COMPARATORThis arm includes 30 OCD patients receiving SSRIs
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
BSMMU
Dhaka, 1000, Bangladesh
Sadia Binte Anwar Sonia
Dhaka, 1000, Bangladesh
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Prof Md. Sayedur Rahman, MBBS, M.Phil
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Resident
Study Record Dates
First Submitted
May 23, 2021
First Posted
May 27, 2021
Study Start
March 13, 2020
Primary Completion
January 10, 2022
Study Completion
January 10, 2022
Last Updated
November 16, 2021
Record last verified: 2021-11