- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04904952
Effect of N-acetylcysteine as Add on Therapy With SSRI in Moderate to Severe OCD Patients
Effect of N-acetylcysteine as Add on Therapy With Selective Serotonin Reuptake Inhibitors in Moderate to Severe Obsessive Compulsive Disorder Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sadia Binte Anwar Sonia, MBBS
- Phone Number: 01752093329
- Email: sadiasonia365@gmail.com
Study Contact Backup
- Name: Prof Md. Sayedur Rahman, MBBS,M.Phil
- Phone Number: 01971840757
- Email: srkhasru@bsmmu.edu.bd
Study Locations
-
-
-
Dhaka, Bangladesh, 1000
- Recruiting
- BSMMU
-
Contact:
- Sadia Binte Anwar Sonia, MBBS
- Phone Number: 01752093329
- Email: sadiasonia365@gmail.com
-
Contact:
- Prof Md. Sayedur Rahman, MBBS,M.Phil
- Phone Number: 01971840757
- Email: srkhasru@bsmmu.edu.bd
-
Dhaka, Bangladesh, 1000
- Recruiting
- Sadia Binte Anwar Sonia
-
Contact:
- Sadia Binte Anwar Sonia, MBBS
- Phone Number: 01752093329
- Email: sadiasonia365@gmail.com
-
Contact:
- Prof Md. Sayedur Rahman, MBBS.Mphil
- Phone Number: 01971840757
- Email: srkhasru@bsmmu.edu.bd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Experimental
This arm includes 30 OCD patients receiving SSRIs
|
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 Comparator: Control
This arm includes 30 OCD patients receiving 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OCD severity score assessment
Time Frame: 10 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurochemical assessment
Time Frame: 10 weeks
|
To estimate the brain glutamate level by Magnetic Resonance Spectroscopy (MRS) at baseline and after 10 weeks supplementation of n-acetylcysteine and SSRI.
To compare the brain glutamate level by Magnetic Resonance Spectroscopy (MRS) at baseline and after 10 weeks supplementation of n-acetylcysteine and SSRI.
|
10 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Prof Md. Sayedur Rahman, MBBS, M.Phil, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSMMU/2021/2300
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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