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Could a single daily dose of clozapine work just as well?

NCT ID NCT02639702

Disease control Sponsor: Centre for Addiction and Mental Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether people with schizophrenia or schizoaffective disorder can safely switch from taking clozapine twice a day to once a day. Participants currently stable on a twice-daily regimen will be randomly assigned to continue that schedule or switch to once-daily dosing, with both groups receiving identical-looking pills to keep the study blinded. Over 12 weeks, researchers will compare changes in psychiatric symptoms and side effects to see if the simpler once-daily schedule holds up.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
clozapine (Clozaril), an antipsychotic medication, given once daily instead of twice daily
What this could lead to
If successful, this could show that once-daily clozapine is as effective and better tolerated, simplifying treatment for people with schizophrenia.
What could go wrong
This is a small pilot study with only 30 participants, so results may not apply broadly. Changing dosing could affect symptom control or side effects.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

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

Started

Oct 2016

Expected to finish

Dec 2027

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Diagnosed with schizophrenia or schizoaffective disorder based on DSM-IV criteria * Outpatient status * Ages 18 years or older * Has received clozapine twice a day, one of which is in the evening/bedtime, at the same dose and dosing regimen for at least 3 months * Fluent in English and competent to provide written informed consent Exclusion Criteria: * Having significant medical or neurological illnesses * Pregnant or lactating

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Conditions

The condition(s) this trial relates to.

Psychotic Disorders schizoaffective disorder schizophrenia

As listed by the trial registrant

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

Schizoaffective disorder Schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre for Addiction and Mental Health

    RECRUITING

    Toronto, Ontario, M5T 1R8, Canada

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