Status:
COMPLETED
CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Schizophrenia
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Signed and dated written informed consent.
- Male or female patients who are 18-50 years (inclusive) of age at time of consent.
- Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).
- \-- Patients must be clinically stable and in the residual (non-acute) phase of their illness with no hospitalization or increase level of care due to worsening of schizophrenia in the past 12 weeks or no uncontrolled positive symptoms.
- Patients should have functional impairment in day-to-day activities per investigator judgement.
- Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.
- Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization.
- Women of childbearing potential must use highly effective methods of birth control.
- Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply.
- Exclusion criteria
- Patient with current DSM-5 diagnosis other than Schizophrenia.
- Cognitive impairment due to other causes, or patients with dementia or epilepsy.
- Severe movement disorders.
- Any suicidal behavior in past year or suicidal ideation in the past 3 months.
- History of moderate or severe substance use disorder within the last 12 months prior to informed consent.
- Positive urine drug screen.
- Patients who were treated with Clozapine, stimulants, ketamine or electroconvulsive therapy within 6 months prior to randomization.
- Current participation in any investigational drug trial.
- Cognitive Remediation Therapy within 12 weeks prior to screening.
- Initiation or change in any type or frequency of psychotherapy within 12 weeks prior to randomization.
- Any clinically significant finding or condition that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
- Haemoglobin (Hb) below lower limit of normal .
- History of haemolytic anaemia, red blood cell (RBC) membrane diseases, known Glucose-6-phosphate dehydrogenase deficiency, anaemia of any cause or patients planning to donate blood.
- Severe renal impairment.
- Indication of liver disease.
- Any documented active or suspected malignancy or history of malignancy within 5 years.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Further exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
August 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2024
Estimated Enrollment :
609 Patients enrolled
Trial Details
Trial ID
NCT04860830
Start Date
August 9 2021
End Date
November 20 2024
Last Update
January 9 2025
Active Locations (110)
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1
Advanced Research Center, Inc.
Anaheim, California, United States, 92805
2
ProScience Research Group
Culver City, California, United States, 90230
3
University of California Los Angeles
Los Angeles, California, United States, 90095
4
CNRI - Los Angeles
Pico Rivera, California, United States, 90660