Depression, AnxietyPhase 1NCT05022524
Exploring Novel Uses of Microbiota Therapy for Managing the Side Effects of Psychiatric Pharmaceutical Interventions
A Phase 1 study testing Acetate (Apple Cider Vinegar) in people with Depression, Anxiety, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
To determine the feasibility of whether the addition of key prebiotics administered orally can mitigate some of the most problematic side-effects of the most common psychiatric medications - weight gain and metabolic abnormalities caused by some antidepressants, mood stabilizers and antipsychotics. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Acetate (Apple Cider Vinegar)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 31 Aug 2024
- Phase
- Phase 1
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- For an eligible patient, all inclusion criteria must be answered "yes"
- Signed informed consent obtained prior to any study-related activities
- Patients of FEMAP who are between the ages of 16 and 28
- Currently on a stable dose of an antidepressant, mood stabilizer, and/or antipsychotic drug AND have experienced what they deem to be problematic weight gain (approximately greater than 5% of initial body weight) that was temporally linked with initiating the drug, as confirmed by a psychiatrist
- Have a body mass index of ≥ 21.7 kg/m2 (midpoint of normal BMI (18.5-24.9).
Who cannot join
- Participants who are unable to follow multi-step instructions independently, as determined by the treating psychiatrist.
- Participants who are pregnant or planning to get pregnant
- Patients on medications that have weight loss as a potential side effect i.e. topiramate, metformin, psychostimulants.
- Current active eating disorder i.e. bulimia nervosa, binge eating disorder, anorexia nervosa
- Currently on a weight-loss diet plan i.e. ketogenic diet, detox diet
- Currently using a medication for weight loss i.e. Contrave (bupropion / naltrexone), Saxenda (liraglutide)
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- Current use of dietary supplements for weight loss i.e. garcinia cambogia; or use within 4 weeks prior to study initiation
- Bowel surgery
- Crohn's disease or other bowel conditions
- Blood/bleeding/liver/kidney disorders
- Currently enrolled in other clinical trial which may affect their study outcome
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
First Episode Mood and Anxiety Disorders Program (FEMAP)
London, Ontario, N6A 3H8
Elizabeth A Osuch, MD, +1-519-646-6000 ext. 65188, FEMAP@lhsc.on.ca
David M Walton, PhD
About this study
Official title: Exploring Novel Uses of Microbiota Therapy for Managing the Side Effects of Psychiatric Pharmaceutical Interventions: An N-of-1 Pilot and Feasibility Study
To determine the feasibility of whether the addition of key prebiotics administered orally can mitigate some of the most problematic side-effects of the most common psychiatric medications - weight gain and metabolic abnormalities caused by some antidepressants, mood stabilizers and antipsychotics. In the initial part of the study, we aim to determine feasibility of the study and evaluate participant compliance.
Our clinical trial will encourage the growth of Akkermansia muciniphila (AM) through enteric-coated orally-administered acetate (apple cider vinegar powder in capsules) in 16-to-28 year-old patients who have already experienced weight gain while on stable doses of psychiatric medication, with the hypothesis that the addition of this prebiotic will result in alterations in gut microbiota and measurable weight loss, as well as improvement in metabolic measurements.
Read more
Primary Objective:
- To evaluate feasibility of using acetate in a large-scale clinical trial, including considerations for protocol, study agent, recruitment, retention, adverse events, budget, staff, facility, and patient experience
- To estimate effect size of change in AM relative abundance by measuring pre- and post-intervention levels for use in designing future large-scale clinical trials
Secondary Objectives:
- To determine whether acetate administered orally shows an observable effect on weight gain as a side effect from antidepressants, mood stabilizers, and/or antipsychotics in a sample of participants already on stable doses of at least one of these medications
- To determine changes in metabolic syndrome profile, as indicated by blood pressure and high-density lipoprotein.
- To conduct preliminary analyses on any possible changes in mood/anxiety symptoms pre- versus post-intervention
- To identify and define other potential confounders or effect modifiers of our primary and secondary objectives that should be considered in future study designs
- Conditions
- Depression, Anxiety
- Being tested
- Acetate (Apple Cider Vinegar)
- Keywords
- Probiotics, Psychiatry, Weight
- Medical subject headings
- Depression, Anxiety Disorders, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetate (Apple Cider Vinegar)Dietary supplement
Consumer-grade apple cider vinegar (ACV) capsules will have extra enteric coating applied for delivery further into the GI tract.
| Study group | Role | What they receive |
|---|---|---|
| Transition-Age Adults | Experimental | 16-25 year old patients on stable dose of antipsychotic medication for treatment of depression or anxiety. Receives: Dietary Supplement: Acetate (Apple Cider Vinegar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment success
Number of potential participants approached to number expressing interest, and number invited to number recruited (recruitment success)
Measured: 5 months
Feasibility: Retention
Number recruited to number retained (attrition)
Measured: 5 months
Feasibility: Adherence
Number adhering to intervention protocol quantified through number of capsules returned at end of trial
Measured: 5 months
Feasibility: Adverse Events
A study-specific data form for collecting adverse events
Measured: 5 months
Akkermansia Muciniphila abundance
Relative abundance (proportion) of AM in stool at inception compared to all other species identified, and change in relative abundance from pre- to post-intervention
Measured: 5 months
Secondary outcomes (5)
Body Weight
Standard Medical-grade floor scale
Measured: 5 months, recorded monthly
Metabolic Indicator: Blood pressure
Blood pressure using medical-grade arm cuff (mm/Hg, Systolic and Diastolic)
Measured: 5 months
Metabolic Indicator: High-Density Lipoproteins
HDL cholesterol assayed from antecubital blood draw, expressed in mg/dL
Measured: 5 months
Mood: Depression
Quick Inventory of Depressive Symptomatology (QIDS-SR, Rush et al. 2003) - baseline scores to describe the sample, change from pre-post intervention to explore potential treatment effect
Measured: 5 months, captured monthly
Mood: Anxiety
Overall Anxiety Severity and Impairment Scale (OASIS, Barlow et al. 2010) - baseline scores to describe the sample, change from pre-post intervention to explore potential treatment effect
Measured: 5 months, captured monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Jun 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- N-of-1 type prospective study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022524
- Sponsor's protocol ID
- 119638
- Status last verified
- Oct 2023
- First submitted
- 30 Jul 2021
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Novel Uses of Microbiota Therapy for Managing the Side Effects of Psychiatric Pharmaceutical Interventions: An N-of-1 Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT05022524
- Acronym / sponsor ID
- 119638
- Conditions
- Depression, Anxiety
- Keywords
- Probiotics, Psychiatry, Weight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 26 Aug 2021 (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.
To determine the feasibility of whether the addition of key prebiotics administered orally can mitigate some of the most problematic side-effects of the most common psychiatric medications - weight gain and metabolic abnormalities caused by some antidepressants, mood stabilizers and antipsychotics. In the initial part of the study, we aim to determine feasibility of the study and evaluate participant compliance.
Our clinical trial will encourage the growth of Akkermansia muciniphila (AM) through enteric-coated orally-administered acetate (apple cider vinegar powder in capsules) in 16-to-28 year-old patients who have already experienced weight gain while on stable doses of psychiatric medication, with the hypothesis that the addition of this prebiotic will result in alterations in gut microbiota and measurable weight loss, as well as improvement in metabolic measurements.
Primary Objective:
- To evaluate feasibility of using acetate in a large-scale clinical trial, including considerations for protocol, study agent, recruitment, retention, adverse events, budget, staff, facility, and patient experience
- To estimate effect size of change in AM relative abundance by measuring pre- and post-intervention levels for use in designing future large-scale clinical trials
Secondary Objectives:
- To determine whether acetate administered orally shows an observable effect on weight gain as a side effect from antidepressants, mood stabilizers, and/or antipsychotics in a sample of participants already on stable doses of at least one of these medications
- To determine changes in metabolic syndrome profile, as indicated by blood pressure and high-density lipoprotein.
- To conduct preliminary analyses on any possible changes in mood/anxiety symptoms pre- versus post-intervention
- To identify and define other potential confounders or effect modifiers of our primary and secondary objectives that should be considered in future study designs
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- N-of-1 type prospective study
| Arm | Type | Receives |
|---|---|---|
| Transition-Age Adults | Experimental | Dietary Supplement: Acetate (Apple Cider Vinegar)16-25 year old patients on stable dose of antipsychotic medication for treatment of depression or anxiety. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- For an eligible patient, all inclusion criteria must be answered "yes"
- Signed informed consent obtained prior to any study-related activities
- Patients of FEMAP who are between the ages of 16 and 28
- Currently on a stable dose of an antidepressant, mood stabilizer, and/or antipsychotic drug AND have experienced what they deem to be problematic weight gain (approximately greater than 5% of initial body weight) that was temporally linked with initiating the drug, as confirmed by a psychiatrist
- Have a body mass index of ≥ 21.7 kg/m2 (midpoint of normal BMI (18.5-24.9).
Key exclusion criteria (11 listed)
- Participants who are unable to follow multi-step instructions independently, as determined by the treating psychiatrist.
- Participants who are pregnant or planning to get pregnant
- Patients on medications that have weight loss as a potential side effect i.e. topiramate, metformin, psychostimulants.
- Current active eating disorder i.e. bulimia nervosa, binge eating disorder, anorexia nervosa
- Currently on a weight-loss diet plan i.e. ketogenic diet, detox diet
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 |
|---|---|---|
| Acetate (Apple Cider Vinegar)Consumer-grade apple cider vinegar (ACV) capsules will have extra enteric coating applied for delivery further into the GI tract. | Dietary supplement | Transition-Age Adults |
Primary outcome
Feasibility: Recruitment success
Time frame: 5 months
Number of potential participants approached to number expressing interest, and number invited to number recruited (recruitment success)
Feasibility: Retention
Time frame: 5 months
Number recruited to number retained (attrition)
Feasibility: Adherence
Time frame: 5 months
Number adhering to intervention protocol quantified through number of capsules returned at end of trial
Feasibility: Adverse Events
Time frame: 5 months
A study-specific data form for collecting adverse events
Akkermansia Muciniphila abundance
Time frame: 5 months
Relative abundance (proportion) of AM in stool at inception compared to all other species identified, and change in relative abundance from pre- to post-intervention
5 secondary outcomes
Body Weight
Time frame: 5 months, recorded monthly
Metabolic Indicator: Blood pressure
Time frame: 5 months
Metabolic Indicator: High-Density Lipoproteins
Time frame: 5 months
Mood: Depression
Time frame: 5 months, captured monthly
Mood: Anxiety
Time frame: 5 months, captured monthly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No. We do not plan to share IPD with other researchers
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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 Phase 1 study testing Acetate (Apple Cider Vinegar) in people with Depression, Anxiety, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 5 inclusion and 11 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 5 Oct 2023. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Elizabeth Osuch, MD (519-646-6000 ext. 65188, elizabeth.osuch@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment success (time frame: 5 months). The study lists 5 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 5 Oct 2023.