Iclepertin for Schizophrenia

Recruiting in Palo Alto (17 mi)

+157 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 daily pill called Iclepertin can improve learning and memory in adults with schizophrenia. Participants take either Iclepertin or another pill for several months while continuing their usual medication. Doctors regularly check their mental abilities and overall health.

Eligibility Criteria

Adults aged 18-50 with schizophrenia, stable on current antipsychotic treatment (except clozapine), not hospitalized for worsening symptoms in the last 12 weeks. Must have a study partner and be capable of consent. Women must use effective birth control.

Inclusion Criteria

I am taking two antipsychotics, and both are within the recommended dose limits.

I am on a stable dose of my antipsychotic medication, even if the form has changed.

I am not taking more than the allowed dose of any psychoactive medication.

See 21 more

Exclusion Criteria

I haven't used specific medications like Clozapine or undergone treatments like ECT in the last 6 months.

I am between 18 and 50 years old.

Have you been hospitalized for worsening schizophrenia symptoms in the past year?

See 41 more

Treatment Details

Interventions

Iclepertin (Other)

Trial OverviewThe trial tests if Iclepertin improves cognition compared to placebo over 26 weeks. Participants also continue their usual schizophrenia medication, attend regular visits for health checks and cognitive assessments using questionnaires and computer tests.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IclepertinExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention