Exploring Novel Uses of Microbiota Therapy for Managing the Side Effects of Psychiatric Pharmaceutical Interventions

Depression, Anxiety Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05022524
• Other study ID #: 119638
• Status: Recruiting
• Phase: Phase 1
• Start date: June 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: Lawson Health Research Institute
• Contact: Elizabeth Osuch, MD
• Phone: 519-646-6000
• Email: elizabeth.osuch[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

Inclusion Criteria:

For an eligible patient, all inclusion criteria must be answered "yes"

1. Signed informed consent obtained prior to any study-related activities

2. Patients of FEMAP who are between the ages of 16 and 28

3. 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

4. Have a body mass index of = 21.7 kg/m2 (midpoint of normal BMI (18.5-24.9).

Exclusion Criteria:

1. Participants who are unable to follow multi-step instructions independently, as determined by the treating psychiatrist.

2. Participants who are pregnant or planning to get pregnant

3. Patients on medications that have weight loss as a potential side effect i.e. topiramate, metformin, psychostimulants.

4. Current active eating disorder i.e. bulimia nervosa, binge eating disorder, anorexia nervosa

5. Currently on a weight-loss diet plan i.e. ketogenic diet, detox diet

6. Currently using a medication for weight loss i.e. Contrave (bupropion / naltrexone), Saxenda (liraglutide)

7. Current use of dietary supplements for weight loss i.e. garcinia cambogia; or use within 4 weeks prior to study initiation

8. Bowel surgery

9. Crohn's disease or other bowel conditions

10. Blood/bleeding/liver/kidney disorders

11. Currently enrolled in other clinical trial which may affect their study outcome

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety

Intervention

Dietary Supplement:
• Acetate (Apple Cider Vinegar)
Consumer-grade apple cider vinegar (ACV) capsules will have extra enteric coating applied for delivery further into the GI tract.

Locations

Country	Name	City	State
Canada	First Episode Mood and Anxiety Disorders Program (FEMAP)	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Recruitment success	Number of potential participants approached to number expressing interest, and number invited to number recruited (recruitment success)	5 months
Primary	Feasibility: Retention	Number recruited to number retained (attrition)	5 months
Primary	Feasibility: Adherence	Number adhering to intervention protocol quantified through number of capsules returned at end of trial	5 months
Primary	Feasibility: Adverse Events	A study-specific data form for collecting adverse events	5 months
Primary	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	5 months
Secondary	Body Weight	Standard Medical-grade floor scale	5 months, recorded monthly
Secondary	Metabolic Indicator: Blood pressure	Blood pressure using medical-grade arm cuff (mm/Hg, Systolic and Diastolic)	5 months
Secondary	Metabolic Indicator: High-Density Lipoproteins	HDL cholesterol assayed from antecubital blood draw, expressed in mg/dL	5 months
Secondary	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	5 months, captured monthly
Secondary	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	5 months, captured monthly