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Gut bugs linked to antipsychotic weight gain in youth

NCT ID NCT03414151

Knowledge-focused Sponsor: Centre for Addiction and Mental Health Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how gut bacteria change when young people (ages 12-35) with psychosis start taking antipsychotic medication. Researchers want to see if these changes are linked to weight gain and other metabolic problems. Participants provide stool and blood samples over 12 weeks. The goal is to better understand why these medications cause weight gain, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2018

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants will include individuals who are either antipsychotic naïve or have not taken antipsychotics for at least 3 months prior to study participation. Participants will be between 12 and 35 years of age with a diagnosis of schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum and other psychotic disorder, as per DSM-V criteria.

Ages

12 to 35 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ages 12-35 * Antipsychotic naïve or antipsychotic treatment for equal to or less than 2 weeks within the past 3 months; the minimum AP dose will be left to the discretion of the PI * DSM-5 diagnosis (using SCID-IV-TR with supplemental questions from SCID-5 or SCID-5) of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, and brief psychotic disorder, psychotic disorder NOS. and/or antipsychotic treatment for schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum and other psychotic disorder. Exclusion Criteria: * Previous antipsychotic treatment (greater than two weeks within the preceding 3 months) * Presence of DSM-5 diagnosis which is not schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum and other psychotic disorder * Use of any other medications for treatment of lipids, glucose, or weight as deemed to be clinically significant by the PI * Use of other medications where the dose has changed within the past 6 weeks which are deemed by the PI to be clinically significant * Pregnancy * Eating disorder - active or previous * Major medical or surgical event within the preceding 3 months * Acute suicidal risk * Irritable bowel disease, Crohn's disease, and/or diverticulitis/diverticulosis * Type I diabetes, kidney/liver disease, and/or cancer * Organ transplant * Moderate to severe alcohol use , use of street drugs, and/or cannabis use (as deemed by PI) * Immunosuppressants and/or anti-inflammatory medications * Antibiotic/probiotic use within past 4 weeks * Any other medical conditions or lifestyle habits deemed by the PI to impact the integrity of the sample/microbiota

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Conditions

The condition(s) this trial relates to.

delusional disorder psychotic disorder Psychotic Disorders schizoaffective disorder schizophrenia schizophreniform disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Psychotic disorder Schizophrenia

Contacts and locations

Locations

  • Centre For Addiction and Mental Health

    Toronto, Ontario, M5T1R8, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.