Iclepertin for Schizophrenia

Recruiting in Palo Alto (17 mi)

+143 other locations

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Boehringer Ingelheim

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests if a medicine called Iclepertin can help improve memory and learning in adults with schizophrenia. Participants take Iclepertin daily while continuing their usual medication. Doctors regularly check their mental abilities and health throughout the study. Iclepertin is being studied for its potential to improve cognitive functions in schizophrenia.

Eligibility Criteria

Adults aged 18-50 with schizophrenia, stable on current antipsychotic treatment (except clozapine), and experiencing functional impairment in daily activities can join. They must not have been hospitalized for worsening schizophrenia recently, use effective birth control if applicable, and have a study partner who meets regularly.

Inclusion Criteria

I've been on the same antipsychotic medication for at least 12 weeks.

I have schizophrenia, am stable, and struggle with daily activities.

I take no more than 1 mg of lorazepam or its equivalent daily.

I am using or willing to use effective birth control and agree to pregnancy tests.

I am between 18 and 50 years old.

I haven't been hospitalized or needed more psychiatric care for my schizophrenia in the last 12 weeks.

I've been on 1 or 2 antipsychotics (not clozapine) for over 12 weeks and on the same dose for at least 35 days.

I take 1 mg or less of lorazepam-equivalent daily.

I meet with my study partner at least once a week in person.

Exclusion Criteria

I have cognitive issues due to a condition like epilepsy, stroke, or head injury.

My side effects from antipsychotic medication can't be managed with low-dose treatments.

I am not taking clozapine.

I have used ketamine or esketamine.

I have not undergone electroconvulsive therapy.

Participant Groups

The trial tests Iclepertin's effect on cognitive functions like learning and memory in people with schizophrenia over 26 weeks. Participants are randomly assigned to receive either Iclepertin or a placebo alongside their standard medication while undergoing regular mental ability assessments.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Iclepertin armExperimental Treatment1 Intervention

Group II: Placebo armPlacebo Group1 Intervention