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New schizophrenia drug passes early safety check

NCT ID NCT02181803

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tested a new drug called MK-8189 in 55 people, including healthy volunteers and those with schizophrenia. The main goal was to see if the drug is safe and how it behaves in the body. Researchers measured drug levels and side effects, but this study did not aim to treat or cure schizophrenia.

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

55 people

The number who actually took part.

Started

Aug 2014

Finished

Apr 2015

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 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: INCLUSION CRITERIA FOR SCHIZOPHRENIA PARTICIPANTS * Male or non-pregnant and non-breast feeding female. If participant is male with a female partner of child-bearing potential, participant must agree to use a medically acceptable method of contraception during the trial and for 120 days after the last dose of trial drug. If their partner is pregnant, males must agree to use a condom * Body Mass Index (BMI) ≥ 18.5 and ≤ 40 kg/m\^2 * Meet diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria with the onset of the first episode being no less than 2 years prior to study entry * Be in the non-acute phase of illness and clinically stable for 3 months prior to screening * History of receiving and tolerating antipsychotic medication within the usual dose range employed for schizophrenia * Participants with hypothyroidism, diabetes, high blood pressure, chronic respiratory conditions or other mild forms of these medical conditions could be considered as candidates for study enrollment if their condition is stable and the prescribed dose and regimen of medication is stable for at least 3 months prior to screening and there are no expected changes in comedication during the study * Has a negative urinary drug screen at screening INCLUSION CRITERIA FOR HEALTHY PARTICIPANTS * Male, or non-pregnant and non-breast feeding female of Japanese or non-Japanese descent. If participant is male with a female partner of child-bearing potential, participant must agree to use a medically acceptable method of contraception during the trial and for 120 days after the last dose of trial drug. If their partner is pregnant, males must agree to use a condom * Body Mass Index (BMI) ≥ 18.5 and ≤ 35 kg/m\^2 * In good health * Nonsmoker and/or has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months * Has a negative urinary drug screen at screening Exclusion Criteria: EXCLUSION CRITERIA FOR SCHIZOPHRENIA PARTICIPANTS * DSM-IV axis I psychiatric diagnosis other than schizophrenia or schizoaffective disorder within one month of screening * Has evidence or history of mental retardation, borderline personality disorder, anxiety disorder, or organic brain syndrome * History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia * Untreated or uncompensated clinically significant renal, endocrine, hepatic, respiratory, gastrointestinal, psychiatric, neurologic, cardiovascular, hematological, immunological or cerebrovascular disease, malignance, allergic disease or other chronic and/or degenerative process at screening * Has a history of cancer (malignancy) with certain exceptions * Treatment with clozapine for schizophrenia or treatment with monoamine oxidase inhibitors within 3 months of screening * Received a parenteral depot antipsychotic medication within 3 months of screening * Participated in another investigational study within 4 weeks, prior to screening EXCLUSION CRITERIA FOR HEALTHY PARTICIPANTS * History of clinically significant endocrine, gastrointestinal, cardiovascular (including hypertension, angina, coronary artery disease, valvular disease, heart rate or rhythm abnormalities), hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases * Mentally or legally incapacitated * History of clinically diagnosed depression, anxiety disorder, or any history of psychiatric disorders having required drug treatment or hospitalization * History of cancer (malignancy) * Unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies throughout the trial * Participated in another investigational study within 4 weeks, prior to screening

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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.

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