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New combo approach for schizophrenia shows promise in small early study

NCT ID NCT05662306

Disease control Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested a combination of long-acting injectable antipsychotic medication and cognitive/functional skills training in people with early schizophrenia. The goal was to see if this approach helps patients achieve stable symptom remission and improve daily functioning. Only one person enrolled before the study was stopped, so results are very limited.

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

1 person

The number who actually took part.

Started

Jan 2024

Finished

Mar 2025

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: 1. Adults 2. Diagnosis of schizophrenia 3. Current Hospitalization or outpatient relapse 4. Fewer than four previous admissions 5. Willing to accept long-acting injectable treatment and participate in rehabilitation Exclusion Criteria: 1. Primary diagnosis other than schizophrenia 2. Prior Long Acting Injectable treatment 3. Current Suicide Risk 4. Hypersensitivity to Aripiprazole 5. Pregnancy 6. Positive illicit drug screen other than cannabis (rescreening allowed in 4 weeks for drug positive cases) 7. Unable to give personal informed consent 8. History of treatment resistance as evidenced by clozapine treatment 9. Unable to stop treatment with medications that are strong Cytochrome (CYP) 2D6 or CYP 3A4 inhibitors and or strong CYP3A4 inducers (2.3, 7.1) for at 14 days prior to initiation.

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Conditions

The condition(s) this trial relates to.

Recurrence schizophrenia

As listed by the trial registrant

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

Schizophrenia

Contacts and locations

Locations

  • Jackson Memorial Hospital

    Miami, Florida, 33136, United States

More trials for these conditions

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