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

NCT05022524 | Unknown Phase 1

• 1 other identifier: 119638
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Depression, Anxiety

Keywords

Probiotics; Psychiatry; Weight

Outcome Measures

Primary Outcomes (5)

• Feasibility: Recruitment success

  Number of potential participants approached to number expressing interest, and number invited to number recruited (recruitment success)

  5 months

• Feasibility: Retention

  Number recruited to number retained (attrition)

  5 months

• Feasibility: Adherence

  Number adhering to intervention protocol quantified through number of capsules returned at end of trial

  5 months

• Feasibility: Adverse Events

  A study-specific data form for collecting adverse events

  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

  5 months

Secondary Outcomes (5)

• Body Weight

  5 months, recorded monthly

• Metabolic Indicator: Blood pressure

  5 months

• Metabolic Indicator: High-Density Lipoproteins

  5 months

• Mood: Depression

  5 months, captured monthly

• Mood: Anxiety

  5 months, captured monthly

Study Arms (1)

Transition-Age Adults

EXPERIMENTAL

16-25 year old patients on stable dose of antipsychotic medication for treatment of depression or anxiety.

Dietary Supplement: Acetate (Apple Cider Vinegar)

Interventions

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.

Transition-Age Adults

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

First Episode Mood and Anxiety Disorders Program (FEMAP)

London, Ontario, N6A 3H8, Canada

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders; Body Weight

Interventions

Acetates

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Central Study Contacts

Elizabeth Osuch, MD

CONTACT

519-646-6000; elizabeth.osuch@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: N-of-1 type prospective study

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 26, 2021
• Study Start: June 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)