OCDNCT03754647
Effect of Vitamin C Upon SSRI-treated OCD Patients
A study testing Vitamin C in people with OCD, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Title: Effect of Vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder (OCD) patients. Purpose of the study: This study aims to examine the effect of vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- OCD
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBangladesh
- Study dates
- 14 Dec 2017to 10 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with OCD diagnosed by Psychiatry Department of BSMMU.
- OCD patients fulfills Diagnostic criteria of DSM-5.
- Insufficient or depleted plasma Vitamin C level 0.2-0.39 mg/dl or 11-28 µmol/L.
- Patients with YBOCS score more than 14.
Who cannot join
- Any physical or systemic illness / handicaps.
- Alcohol or substance abuse or dependence.
- Patients with Diabetes, Malignancy, Renal or Hepatic diseases.
- Patients receiving antidepressants within last 2 months.
- Patients with other psychological disorder (such as schizophrenia, bipolar disorder).
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
BSMMU
Dhaka, 1000
Taslima Akter, MBBS, 01738248318, Taslimamostafij@gmail.com
RAM Mostafizur Rashid, MBBS, 01724840401, mostafizrmc@gmail.com
About this study
Official title: Effect of Vitamin C Upon Selective Serotonin Reuptake Inhibitors-treated Obsessive Compulsive Disorder Patients
Title:
Effect of Vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder (OCD) patients.
Read more
Purpose of the study:
This study aims to examine the effect of vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients.
Method:
It will be a prospective type of interventional study to to assess the effects of vitamin C along with SSRIs upon OCD patients. The study will be conducted in the Department of Pharmacology and Department of Psychiatry, BSMMU, from September 2017 to February 2019. A total of 90 OCD patients will be selected according to inclusion and exclusion criteria. The patients will be divided randomly into 2 groups: group A and group B. Group A will consist of 45 patients who will receive only SSRIs orally daily and group B would consist of 45 patients who will receive vitamin C, 500 mg BID orally daily along with SSRIs for 8 weeks. To see the effects of Vitamin C, Yale-Brown score of obsessive-compulsive disorders (Y-OCD) would be assessed by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at baseline (before vitamin C administration) and 8 weeks after intervention. Biochemical parameters of oxidative stress markers such as plasma malondialdehyde (MDA), plasma reduced glutathione (GSH) and plasma vitamin C level would also be performed at baseline (before vitamin C administration) and 8 weeks after intervention.
Ethical consideration:
The study will follow the principles of the Declaration of Helsinki and of the World Medical Assembly. Patients will be informed about the study in easy language and then informed consent will be taken. This study has no potential risk to the patients. Confidentiality will be strictly maintained.
Read the detailed description
Obsessive compulsive disorder (OCD) is the fourth-most common mental disorder. The World Health Organization (WHO) estimated OCD to be among the top 10 causes of years lived with illness related disability by 2020. Various psychological, social, genetic and biochemical factors are presumed to be involved in the etiology of OCD. Researches so far have indicated that free radical induced injuries are involved in the pathology of OCD. A well-known source of antioxidant is Vitamin C, which is easily available, cheap and more powerful regarding antioxidant effects compared to many other natural sources of vitamin C. Until now little study has been performed to observe the effect of vitamin C administration concurrent to the Selective Serotonin Reuptake Inhibitors (SSRIs) in the treatment of OCD. Therefore the present study has been designed to assess the effects of vitamin C along with SSRIs upon OCD patients. The study would be a prospective type of interventional study to be conducted in the Department of Pharmacology and Department of Psychiatry, BSMMU, from September 2017 to February 2019. A total of 90 OCD patients will be selected according to inclusion and exclusion criteria. The patients will be divided randomly into 2 groups: group A and group B. Group A would consist of 45 patients who will receive only SSRIs orally daily and group B would consist of 45 patients who will receive vitamin C, 500 mg BID orally daily along with SSRIs for 8 weeks. Comparison between the two groups will be performed through biochemical parameters of oxidative stress markers such as serum malondialdehyde (MDA), serum reduced glutathione (GSH) and serum vitamin C levels at baseline (before vitamin C administration) and 8 weeks after intervention by vitamin C. 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).Data would be analyzed by Scientific Package for Social Science(SPSS) and represented by tables and figures as applicable. Significance level would be set at 0.05, 0.01 and 0.001. Patient's data will be recorded in a predetermined data sheet. Patients will be informed about the study in easy language and then informed consent will be taken. This study has no potential risk to the patients. Hence, this study would be the first to examine the efficacy of vitamin C as an adjunct to SSRIs in the treatment of OCD.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
One tablet of Vitamin C (500 mg) twice daily with SSRIs for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving SSRIs | No intervention | This group will be receive SSRIs only |
| Patients receiving Vitamin C with SSRIs | Active comparator | This group will be receive vitamin C (500mg) twice daily with SSRIs for 8 weeks Receives: Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the effect of vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients.
To assess the clinical improvement of OCD patients by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and compare plasma MDA, RBC glutathione, plasma vitamin C levels at baseline and after 8 weeks of treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start14 Dec 2017
- Primary completion10 Feb 2019 (estimated)
- Study completion10 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OCDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Taslima Akter, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754647
- Sponsor's protocol ID
- BSMMU/2018/3110
- Status last verified
- Nov 2018
- First submitted
- 25 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin C Upon Selective Serotonin Reuptake Inhibitors-treated Obsessive Compulsive Disorder Patients
- ClinicalTrials.gov ID
- NCT03754647
- Acronym / sponsor ID
- BSMMU/2018/3110
- Conditions
- OCD
- Keywords
- Vitamin C, OCD, MDA, RBC Glutathione
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 10 Feb 2019 (estimated)
- Study completion
- 10 Feb 2019 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title:
Effect of Vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder (OCD) patients.
Purpose of the study:
This study aims to examine the effect of vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients.
Method:
It will be a prospective type of interventional study to to assess the effects of vitamin C along with SSRIs upon OCD patients. The study will be conducted in the Department of Pharmacology and Department of Psychiatry, BSMMU, from September 2017 to February 2019. A total of 90 OCD patients will be selected according to inclusion and exclusion criteria. The patients will be divided randomly into 2 groups: group A and group B. Group A will consist of 45 patients who will receive only SSRIs orally daily and group B would consist of 45 patients who will receive vitamin C, 500 mg BID orally daily along with SSRIs for 8 weeks. To see the effects of Vitamin C, Yale-Brown score of obsessive-compulsive disorders (Y-OCD) would be assessed by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at baseline (before vitamin C administration) and 8 weeks after intervention. Biochemical parameters of oxidative stress markers such as plasma malondialdehyde (MDA), plasma reduced glutathione (GSH) and plasma vitamin C level would also be performed at baseline (before vitamin C administration) and 8 weeks after intervention.
Ethical consideration:
The study will follow the principles of the Declaration of Helsinki and of the World Medical Assembly. Patients will be informed about the study in easy language and then informed consent will be taken. This study has no potential risk to the patients. Confidentiality will be strictly maintained.
Detailed description
Obsessive compulsive disorder (OCD) is the fourth-most common mental disorder. The World Health Organization (WHO) estimated OCD to be among the top 10 causes of years lived with illness related disability by 2020. Various psychological, social, genetic and biochemical factors are presumed to be involved in the etiology of OCD. Researches so far have indicated that free radical induced injuries are involved in the pathology of OCD. A well-known source of antioxidant is Vitamin C, which is easily available, cheap and more powerful regarding antioxidant effects compared to many other natural sources of vitamin C. Until now little study has been performed to observe the effect of vitamin C administration concurrent to the Selective Serotonin Reuptake Inhibitors (SSRIs) in the treatment of OCD. Therefore the present study has been designed to assess the effects of vitamin C along with SSRIs upon OCD patients. The study would be a prospective type of interventional study to be conducted in the Department of Pharmacology and Department of Psychiatry, BSMMU, from September 2017 to February 2019. A total of 90 OCD patients will be selected according to inclusion and exclusion criteria. The patients will be divided randomly into 2 groups: group A and group B. Group A would consist of 45 patients who will receive only SSRIs orally daily and group B would consist of 45 patients who will receive vitamin C, 500 mg BID orally daily along with SSRIs for 8 weeks. Comparison between the two groups will be performed through biochemical parameters of oxidative stress markers such as serum malondialdehyde (MDA), serum reduced glutathione (GSH) and serum vitamin C levels at baseline (before vitamin C administration) and 8 weeks after intervention by vitamin C. 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).Data would be analyzed by Scientific Package for Social Science(SPSS) and represented by tables and figures as applicable. Significance level would be set at 0.05, 0.01 and 0.001. Patient's data will be recorded in a predetermined data sheet. Patients will be informed about the study in easy language and then informed consent will be taken. This study has no potential risk to the patients. Hence, this study would be the first to examine the efficacy of vitamin C as an adjunct to SSRIs in the treatment of OCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving SSRIs | No intervention | –This group will be receive SSRIs only |
| Patients receiving Vitamin C with SSRIs | Active comparator | Dietary Supplement: Vitamin CThis group will be receive vitamin C (500mg) twice daily with SSRIs for 8 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with OCD diagnosed by Psychiatry Department of BSMMU.
- OCD patients fulfills Diagnostic criteria of DSM-5.
- Insufficient or depleted plasma Vitamin C level 0.2-0.39 mg/dl or 11-28 µmol/L.
- Patients with YBOCS score more than 14.
Key exclusion criteria (5 listed)
- Any physical or systemic illness / handicaps.
- Alcohol or substance abuse or dependence.
- Patients with Diabetes, Malignancy, Renal or Hepatic diseases.
- Patients receiving antidepressants within last 2 months.
- Patients with other psychological disorder (such as schizophrenia, bipolar disorder).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin COne tablet of Vitamin C (500 mg) twice daily with SSRIs for 8 weeks | Dietary supplement | Patients receiving Vitamin C with SSRIs |
Primary outcome
To examine the effect of vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients.
Time frame: 8 weeks
To assess the clinical improvement of OCD patients by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and compare plasma MDA, RBC glutathione, plasma vitamin C levels at baseline and after 8 weeks of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with OCD, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taslima Akter, MBBS (01738248318, taslimamostafij@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the effect of vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.