Schizophrenia treatment could go from daily pills to four shots a year
NCT ID NCT06276361
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase study tested a new long-acting injection of the antipsychotic drug risperidone that would only need to be given once every three months. Fifty-eight adults with stable schizophrenia received a single shot at different doses to measure how the drug moves through the body and to check for safety issues. The goal is to see if this quarterly shot could eventually offer a more convenient option for people who currently take daily risperidone pills.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- risperidone (quarterly injection)
- What this could lead to
- If successful, this could lead to a once-every-three-months injection for schizophrenia, reducing the need for daily pills.
- What could go wrong
- This is a very early Phase 1 study with only 58 participants, focused on safety and drug levels, not on how well it controls symptoms. The injection may not work as well as daily medication, and side effects are still being evaluated.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
58 people
The number who actually took part.
- Started
-
Sep 2023
- Finished
-
Jul 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- 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 Hide 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: * Capable of providing informed consent. * Male or female aged ≥ 18 years to \< 65 years with BMI ≥17.0 to ≤35.0 kg/m2 * Current diagnosis of schizophrenia, according to the Diagnostic and DSM-5 criteria. * Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment * currently taking oral risperidone as maintenance therapy * Score of ≤ 4 (moderately ill at most) on the Clinical Global Impression - Severity of Illness (CGI-S) * If a sexually active female of childbearing potential, using a medically accepted method of birth control. Exclusion Criteria: * Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator could interfere with the interpretation of safety and PK evaluations * If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of study drug or is breastfeeding a child. * History of neuroleptic malignant syndrome and current or past history of clinically significant tardive dyskinesia. * The participant has a primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment * Positive test result for drugs of abuse or alcohol unless the positive finding can be accounted for by documented prescription use. * In the investigator's opinion, at imminent risk of committing self-harm or harm to others. * Unwilling to discontinue any of the prohibited medications prior to the baseline visit or unable to safely washout such medication without significant destabilization or increased risk of self-harm (suicide). * Receipt study drug in another investigational study in the last 90 days. * Current participation in any other clinical trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Schizophrenia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Investigational Site
Amman, Jordan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Your voice may reveal if You're taking your psychiatric medication
- Scientists probe brain's reward system in mental illness
- New schizophrenia drug targets brain glutamate, not dopamine
- New drug candidate takes aim at schizophrenia symptoms
- New schizophrenia drug goes Head-to-Head with standard antipsychotics in Long-Term trial
- Five-Year safety check for experimental schizophrenia drug