Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)
Public ClinicalTrials.gov record NCT04846868. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of Iclepertin Once Daily Over 26 Week Treatment Period in Patients With Schizophrenia (CONNEX-1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia. Participants are put into two groups randomly, which means by chance. One group takes Iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like Iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia. During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups. Participants are in the study for about 8 months and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.
Study identification
- NCT ID
- NCT04846868
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 620 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 8, 2021 (Actual)
- Primary completion
- Sep 17, 2024 (Actual)
- Completion
- Oct 1, 2024 (Actual)
- Last update posted
- Nov 5, 2025
2021 – 2024
United States locations
- U.S. sites
- 18
- U.S. states
- 9
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Collaborative Neuroscience Network, LLC (CNS) | Garden Grove | California | 92845 | — |
| Omega Clinical Trials,LLC | La Habra | California | 90631 | — |
| Artemis Institute for Clinical Research, LLC | San Diego | California | 92103 | — |
| Velocity Clinical Research-Santa Ana-68902 | Santa Ana | California | 92704 | — |
| Institute of Living | Hartford | Connecticut | 06106 | — |
| San Marcus Research Clinic, Inc. | Miami | Florida | 33014 | — |
| CCM Clinical Research Group, LLC-Miami-68482 | Miami | Florida | 33133 | — |
| Atlanta Center | Atlanta | Georgia | 30331 | — |
| University at Buffalo, The State University of New York | Buffalo | New York | 14215 | — |
| Richmond Behavioral Associates-Staten Island-68636 | Staten Island | New York | 10314 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| Neuro-Behavioral Clinical Research | North Canton | Ohio | 44720 | — |
| PeaceHealth Medical Group | Eugene | Oregon | 97401 | — |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | — |
| InSite Clinical Research | DeSoto | Texas | 75115 | — |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | — |
| Houston Mind and Brain | Houston | Texas | 77055 | — |
| Core Clinical Research | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 98 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04846868, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 5, 2025 · Synced Oct 15, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04846868 live on ClinicalTrials.gov.