LY2140023
DrugAdministered orally, twice daily for 104 weeks
Other names: metabotropic glutamate (mGlu) 2/3 Prodrug II
NCT Number: NCT01129674
The primary purpose of the study is to help answer the following research questions:
How LY 2140023 can be tolerated by patients with Schizophrenia compared to standard of care treatment in 52 weeks time period.
Whether LY 2140023 can help patients with Schizophrenia.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 2 / Phase 3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Zagreb, Croatia
The study includes 2 treatment periods. Study Period I will begin at participant randomization (enrollment into Study HBBO) and continue through the first 2 years of treatment. Study Period II will be only for participants randomized to treatment with LY2140023, and will begin after the participant has completed the second year of treatment. Participants who qualify for enrollment will be randomized in a 3:1 ratio (LY2140023 versus standard of care, respectively) into 2 treatment groups: flexible, twice-daily dose of LY2140023 or standard-of-care (olanzapine, risperidone, aripiprazole, or quetiapine). Those assigned to LY2140023 will have the option to continue on LY2140023 after 2 years if deemed appropriate by the investigator.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered orally, twice daily for 104 weeks
Other names: metabotropic glutamate (mGlu) 2/3 Prodrug II
Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
Other names: Zyprexa, LY170053
Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
Time frame: Baseline through 52 weeks
Time frame: Baseline, 52 weeks
Time frame: Baseline, 52 weeks
Time frame: Baseline, 52 weeks
Time frame: 52 weeks, 104 weeks, end of study
Time frame: Baseline, 52 weeks
Time frame: Baseline, 52 weeks
Time frame: Baseline, 104 weeks
Time frame: Baseline, 104 weeks
Time frame: 52 weeks, 104 weeks
Time frame: 52 weeks, 104 weeks
Time frame: 52 weeks, 104 weeks
Time frame: 104 weeks, end of study
Time frame: Baseline, 104 weeks
Time frame: Baseline, 104 weeks
Time frame: Baseline, 52 weeks
Time frame: 104 weeks, end of study
Time frame: Baseline, 52 Weeks
Looking for future studies?
Notify MeDenovo Biopharma LLC
Industry
A Long-Term, Open-Label, Multicenter Study of LY2140023 Compared to Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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