Obsessive-Compulsive DisorderPhase 4NCT02334644
Probiotic Treatment in Adult Obsessive-Compulsive Disorder
A Phase 4 study testing Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) in people with Obsessive-Compulsive Disorder, run by McMaster University at 1 site in Canada.
Trial summary
This study will evaluate the effectiveness of 12-weeks of probiotic treatment in adults with primary Obsessive-Compulsive Disorder and whether this treatment will alter the microbiota composition in these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to 30 Apr 2021
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a principal diagnosis of OCD (DSM 5) according to the MINI with a Y-BOCS score of ≥20
- The ability to comprehend and satisfactorily comply with protocol requirements
- Written informed consent given prior to beginning of the study.
- Current use of any psychotropic agent is permitted given that that individual has been on a stable dose for at least 8 weeks.
Who cannot join
- Participants with current Major Depressive Disorder.
- A MADRS score ≥ 18. Patients with significant suicidal ideation (MADRS item 10 ≥ 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- Individuals with current autoimmune disorders (rheumatoid arthiritis, systemic lupus erythematosus, multiple sclerosis, etc.), inflammatory bowel disease, diabetes.
- Current use of herbal psychoactive treatments i.e. St. John's Wort, Kava Kava, Chamomile Extract, Valeria. Past use is permitted if treatment ended 3 months prior to entering the study and stool sampling.
- Participants receiving current psychotherapy, including cognitive behavioural therapy for an anxiety or mood disorder. Past psychotherapy is permitted if treatment ended 3 months prior to entering the study and stool sampling.
- Patients who currently fulfill criteria for a lifetime history of bipolar disorder, history of drug abuse, a history of schizophrenia or other psychotic disorders, delirium, dementia and amnesic and other cognitive disorders, or are in a current agitated state.
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- Patients meeting criteria for current substance use disorder.
- Antibiotic or probiotic use within 8 weeks of entering the study and stool sampling.
- Reports frequent consumption of foods rich in/enriched with probiotics (yogurt etc).
- Individuals with immune-compromised conditions (i.e. AIDS, lymphoma) or those undergoing long-term corticosteroid treatment.
- Individuals with a soy or lactose allergy.
- Female participants must not be breastfeeding, pregnant or seeking to get pregnant during the course of this study.
- History of allergic response to probiotics or any other related drugs.
- Currently physically unwell including experiencing nausea, fever, vomiting, abdominal pain, bloody diarrhea.
- Individuals with prosthetic heart valves, or a history of valvular heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-week Randomized Controlled Trial of Probiotic Treatment (Lactobacillus Helveticus R0052 and Bifidobacterium Longum R0175) vs Placebo in Adult Obsessive Compulsive Disorder
This study will evaluate the effectiveness of 12-weeks of probiotic treatment in adults with primary Obsessive-Compulsive Disorder and whether this treatment will alter the microbiota composition in these patients.
Read the detailed description
The study will be a prospective, randomized, double blind placebo-controlled trial. The study population will include males and females, ages 18-65, who fulfill criteria for primary DSM-5 OCD as determined by a structured interview. At screening, patients must have a YBOCS score ≥20 and a MADRS score ≤18.
If deemed eligible, patients will provide a stool sample for microbiome profiling and a blood sample for the inflammatory marker analysis. They will return for their first visit where clinician and self-rated symptom severity scales will be completed and patients will begin their randomly assigned treatment condition. Contents of two sachets (probiotic or placebo) will be consumed daily with or just after breakfast.The participants will attend 3 additional study visits, once every 4 weeks and one phone visit at week 6. During these visits, the same clinician and self-reported questionnaires will be completed. At week 6, patients will be contacted by phone to complete the YBOCS and will also provide a midpoint stool sample. At the final visit (week 12) patients will provide a third stool sample for microbiome profiling and a blood sample for inflammatory marker analysis.
Participants will be assessed using the Mini International Neuropsychiatric Interview (MINI) to determine whether criteria for a primary OCD diagnosis is met alongside any additional comorbid disorders.
Participants will complete a number of clinician and self-rated symptom severity scales as listed below:
- Yale Brown Obsessive-Compulsive Scale (YBOCS) - Clinician-rated
- Montgomery Asberg Depression Rating Scale (MADRS) - Clinician-rated
- Obsessive-Compulsive Inventory - Revised (OCI-R) - Self-rated
- Depression Anxiety Stress Scale (DASS-21) - Self-rated
- Dutch Dimensional Obsessive-Compulsive Scale (DDOCS) - Self-rated
- Sheehan Disability Scale (SDS) - Self- rated
- Quality of Life and Enjoyment Satisfaction Questionnaire - Short Form (Q-LES-Q-SF), Self-rated They will also complete additional questionnaires pertaining to their diet and bowel functioning:
- Gastrointestinal Symptom Rating Scale (GSRS)
- Short-form Leeds Dyspepsia Questionnaire (SF-LDQ)
- Rome III criteria for Irritable Bowel Syndrome
- Assessment of diet using the EPIC-Norfolk Food Frequency Questionnaire.
Subjects will also be asked to provide background information regarding travel in the past 4 months and current place (and duration) of residence as these factors may potentially affect the microbiome profile.
Patients will be weighed and their height measured to determine body mass index (BMI).
Those who meet study criteria will be provided with a collection kit and instructed on appropriate fecal sample collection. Participants will also be given a lab requisition and instructed to have blood drawn at a local lab. This blood sample will examine serum levels of IL-6, IL-1β, IL-10, IFNγ, TNF- α and CRP. Liquid Chromatography-Mass Spectrometry (LC-MS) will be used for a kynurenine/tryptophan analysis.
Fecal Sample Collection Patients and healthy controls will collect fecal samples at home using our well-established protocol. During the recruitment visit, the subjects will be provided a kit containing a single 50-ml sterile vial with an air-tight sachet, and a cooling pad. The stool sample will be brought to the MacAnxiety Research Centre, where it will be stored in -80ºC freezer until the samples are analyzed. All participants will be asked to freeze their samples and deliver them to the MacAnxiety Research Centre 2 weeks following sampling, or earlier.
The visits will be organized as follows:
- Baseline Visit (visit 1): once blood and stool samples have been collected the patients will be randomized to probiotic or placebo treatment. At this visit patients will begin their randomly assigned treatment condition to probiotic (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) or placebo. The patients will be provided with 60 sachets (probiotic or placebo) and instructed to consume 2 daily sachets with or just after breakfast. At each of the following visit they will be provided with additional 60 sachets. In this visit the clinician will also complete the following scales:
- Clinical Global Impression - Improvement (CGI-I) - Clinician-rated ii. Clinical Global Impression - Severity (CGI-S) - Clinician-rated iii. Y-BOCS iv. MADRS Participants will complete the following scales:
- Obsessive-Compulsive Inventory - Revised (OCI-R)
- Depression Anxiety Stress Scale (DASS-21)
- Dutch Dimensional Obsessive-Compulsive Scale (DDOCS)
- Sheehan Disability Scale (SDS)
- Q-LES-Q - short form
- During the 12 week period of probiotic treatment, subjects will attend 3 additional visits, once every 4 weeks. During each visit (visits 2-4) participants will be assessed by the study physician. In each visit the clinician will also complete the following scales:
- Clinical Global Impression - Improvement (CGI-I) - Clinician-rated ii. Clinical Global Impression - Severity (CGI-S) - Clinician-rated iii. Y-BOCS iv. MADRS Participants will complete the following scales:
- Obsessive-Compulsive Inventory - Revised (OCI-R)
- Depression Anxiety Stress Scale (DASS-21)
- Dutch Dimensional Obsessive-Compulsive Scale (DDOCS)
- Sheehan Disability Scale (SDS)
- Q-LES-Q - short form
- At week 6, patients will provide a midpoint stool sample as per the sample collection protocol outlined above. A member from the research team will also contact the patient via telephone to complete the YBOCS.
- Visit 4 (week 12): Participants will undergo usual assessment, treatment response will also be determined at this visit (CGI-I score ≤ 2 as well as a 30% drop in YBOCS score). Participants will also complete the Quality of Life and Enjoyment Satisfaction Questionnaire. Patient diet will be assessed using the EPIC-Norfolk Food Frequency Questionnaire. At visit 3, participants will be provided with a collection kit and instructed on appropriate fecal sample collection (as outlined above). The sample should be collected on the prior day to visit 4. Blood samples will be drawn again be drawn at a local lab to examine levels of IL-6, IL-1β, IL-10, IFNγ, TNF- α and CRP. Liquid Chromatography-Mass Spectrometry (LC-MS) will again be used for a kynurenine/tryptophan analysis.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175), Placebo
- Keywords
- Treatment, Natural Health Product, Anxiety
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175)Dietary supplement
2 sachets/day x 12 weeks
PlaceboDietary supplement
2 sachets/day x 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) Receives: Dietary Supplement: Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) |
| 2 | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive-Compulsive Scale [YBOCS]
Measured: 12 weeks
Clinical Global Impression - Improvement ≤ 2 [CGI-I]
Measured: 12 weeks
Secondary outcomes (6)
Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire
Measured: 12 weeks
Sheehan Disability Scale
Measured: 12 weeks
Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: 12 weeks
Obsessive-Compulsive Inventory - Revised
Measured: 12 weeks
Depression Anxiety Stress Scale
Measured: 12 weeks
Dutch Dimensional Obsessive-Compulsive Scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study start1 Sep 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Why it stopped: drug expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Lallemand Health Solutions
- Responsible party
- Sponsor
- Investigators
- Michael Van Ameringen, MD, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334644
- Sponsor's protocol ID
- 15-049
- Status last verified
- Sep 2021
- First submitted
- 6 Jan 2015
- Last updated
- 10 Sep 2021
- 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 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomized Controlled Trial of Probiotic Treatment (Lactobacillus Helveticus R0052 and Bifidobacterium Longum R0175) vs Placebo in Adult Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT02334644
- Acronym / sponsor ID
- 15-049
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Treatment, Natural Health Product, Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: drug expired
- Enrolment
- 15 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, Lallemand Health Solutions
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 8 Jan 2015 (estimated)
- 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.
This study will evaluate the effectiveness of 12-weeks of probiotic treatment in adults with primary Obsessive-Compulsive Disorder and whether this treatment will alter the microbiota composition in these patients.
Detailed description
The study will be a prospective, randomized, double blind placebo-controlled trial. The study population will include males and females, ages 18-65, who fulfill criteria for primary DSM-5 OCD as determined by a structured interview. At screening, patients must have a YBOCS score ≥20 and a MADRS score ≤18.
If deemed eligible, patients will provide a stool sample for microbiome profiling and a blood sample for the inflammatory marker analysis. They will return for their first visit where clinician and self-rated symptom severity scales will be completed and patients will begin their randomly assigned treatment condition. Contents of two sachets (probiotic or placebo) will be consumed daily with or just after breakfast.The participants will attend 3 additional study visits, once every 4 weeks and one phone visit at week 6. During these visits, the same clinician and self-reported questionnaires will be completed. At week 6, patients will be contacted by phone to complete the YBOCS and will also provide a midpoint stool sample. At the final visit (week 12) patients will provide a third stool sample for microbiome profiling and a blood sample for inflammatory marker analysis.
Participants will be assessed using the Mini International Neuropsychiatric Interview (MINI) to determine whether criteria for a primary OCD diagnosis is met alongside any additional comorbid disorders.
Participants will complete a number of clinician and self-rated symptom severity scales as listed below:
- Yale Brown Obsessive-Compulsive Scale (YBOCS) - Clinician-rated
- Montgomery Asberg Depression Rating Scale (MADRS) - Clinician-rated
- Obsessive-Compulsive Inventory - Revised (OCI-R) - Self-rated
- Depression Anxiety Stress Scale (DASS-21) - Self-rated
- Dutch Dimensional Obsessive-Compulsive Scale (DDOCS) - Self-rated
- Sheehan Disability Scale (SDS) - Self- rated
- Quality of Life and Enjoyment Satisfaction Questionnaire - Short Form (Q-LES-Q-SF), Self-rated They will also complete additional questionnaires pertaining to their diet and bowel functioning:
- Gastrointestinal Symptom Rating Scale (GSRS)
- Short-form Leeds Dyspepsia Questionnaire (SF-LDQ)
- Rome III criteria for Irritable Bowel Syndrome
- Assessment of diet using the EPIC-Norfolk Food Frequency Questionnaire.
Subjects will also be asked to provide background information regarding travel in the past 4 months and current place (and duration) of residence as these factors may potentially affect the microbiome profile.
Patients will be weighed and their height measured to determine body mass index (BMI).
Those who meet study criteria will be provided with a collection kit and instructed on appropriate fecal sample collection. Participants will also be given a lab requisition and instructed to have blood drawn at a local lab. This blood sample will examine serum levels of IL-6, IL-1β, IL-10, IFNγ, TNF- α and CRP. Liquid Chromatography-Mass Spectrometry (LC-MS) will be used for a kynurenine/tryptophan analysis.
Fecal Sample Collection Patients and healthy controls will collect fecal samples at home using our well-established protocol. During the recruitment visit, the subjects will be provided a kit containing a single 50-ml sterile vial with an air-tight sachet, and a cooling pad. The stool sample will be brought to the MacAnxiety Research Centre, where it will be stored in -80ºC freezer until the samples are analyzed. All participants will be asked to freeze their samples and deliver them to the MacAnxiety Research Centre 2 weeks following sampling, or earlier.
The visits will be organized as follows:
- Baseline Visit (visit 1): once blood and stool samples have been collected the patients will be randomized to probiotic or placebo treatment. At this visit patients will begin their randomly assigned treatment condition to probiotic (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) or placebo. The patients will be provided with 60 sachets (probiotic or placebo) and instructed to consume 2 daily sachets with or just after breakfast. At each of the following visit they will be provided with additional 60 sachets. In this visit the clinician will also complete the following scales:
- Clinical Global Impression - Improvement (CGI-I) - Clinician-rated ii. Clinical Global Impression - Severity (CGI-S) - Clinician-rated iii. Y-BOCS iv. MADRS Participants will complete the following scales:
- Obsessive-Compulsive Inventory - Revised (OCI-R)
- Depression Anxiety Stress Scale (DASS-21)
- Dutch Dimensional Obsessive-Compulsive Scale (DDOCS)
- Sheehan Disability Scale (SDS)
- Q-LES-Q - short form
- During the 12 week period of probiotic treatment, subjects will attend 3 additional visits, once every 4 weeks. During each visit (visits 2-4) participants will be assessed by the study physician. In each visit the clinician will also complete the following scales:
- Clinical Global Impression - Improvement (CGI-I) - Clinician-rated ii. Clinical Global Impression - Severity (CGI-S) - Clinician-rated iii. Y-BOCS iv. MADRS Participants will complete the following scales:
- Obsessive-Compulsive Inventory - Revised (OCI-R)
- Depression Anxiety Stress Scale (DASS-21)
- Dutch Dimensional Obsessive-Compulsive Scale (DDOCS)
- Sheehan Disability Scale (SDS)
- Q-LES-Q - short form
- At week 6, patients will provide a midpoint stool sample as per the sample collection protocol outlined above. A member from the research team will also contact the patient via telephone to complete the YBOCS.
- Visit 4 (week 12): Participants will undergo usual assessment, treatment response will also be determined at this visit (CGI-I score ≤ 2 as well as a 30% drop in YBOCS score). Participants will also complete the Quality of Life and Enjoyment Satisfaction Questionnaire. Patient diet will be assessed using the EPIC-Norfolk Food Frequency Questionnaire. At visit 3, participants will be provided with a collection kit and instructed on appropriate fecal sample collection (as outlined above). The sample should be collected on the prior day to visit 4. Blood samples will be drawn again be drawn at a local lab to examine levels of IL-6, IL-1β, IL-10, IFNγ, TNF- α and CRP. Liquid Chromatography-Mass Spectrometry (LC-MS) will again be used for a kynurenine/tryptophan analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175)Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) |
| 2 | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a principal diagnosis of OCD (DSM 5) according to the MINI with a Y-BOCS score of ≥20
- The ability to comprehend and satisfactorily comply with protocol requirements
- Written informed consent given prior to beginning of the study.
- Current use of any psychotropic agent is permitted given that that individual has been on a stable dose for at least 8 weeks.
Key exclusion criteria (15 listed)
- Participants with current Major Depressive Disorder.
- A MADRS score ≥ 18. Patients with significant suicidal ideation (MADRS item 10 ≥ 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- Individuals with current autoimmune disorders (rheumatoid arthiritis, systemic lupus erythematosus, multiple sclerosis, etc.), inflammatory bowel disease, diabetes.
- Current use of herbal psychoactive treatments i.e. St. John's Wort, Kava Kava, Chamomile Extract, Valeria. Past use is permitted if treatment ended 3 months prior to entering the study and stool sampling.
- Participants receiving current psychotherapy, including cognitive behavioural therapy for an anxiety or mood disorder. Past psychotherapy is permitted if treatment ended 3 months prior to entering the study and stool sampling.
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 |
|---|---|---|
| Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175)2 sachets/day x 12 weeks | Dietary supplement | 1 |
| Placebo2 sachets/day x 12 weeks | Dietary supplement | 2 |
Primary outcome
Yale Brown Obsessive-Compulsive Scale [YBOCS]
Time frame: 12 weeks
Clinical Global Impression - Improvement ≤ 2 [CGI-I]
Time frame: 12 weeks
6 secondary outcomes
Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire
Time frame: 12 weeks
Sheehan Disability Scale
Time frame: 12 weeks
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 12 weeks
Obsessive-Compulsive Inventory - Revised
Time frame: 12 weeks
Depression Anxiety Stress Scale
Time frame: 12 weeks
Dutch Dimensional Obsessive-Compulsive Scale
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: drug expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
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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.
Michael Van Ameringen, MD, FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) in people with Obsessive-Compulsive Disorder, run by McMaster University at 1 site in Canada.
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 15 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: stopped early, as of the sponsor's last update on 10 Sep 2021. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: drug expired). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Brown Obsessive-Compulsive Scale [YBOCS] (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 10 Sep 2021.