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A study in Schizophrenic patients

A Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 in Patients with DSM-IV-TR Schizophrenia

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0000980
Enrollment
200
Registered
2014-01-13
Start date
2011-10-11
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : LY2140023 (5 mg BID, 40 mg BID or 80 mg BID , oral.

Sponsors

Eli Lilly Korea
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [1] Patients are males or females, 20 to 65 years of age (inclusive) at study entry, with a diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV-TR (SCID) at Visit 1.

Exclusion criteria

Exclusion criteria: [1] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [2] Are Lilly employees. [3] Have any other current Axis I psychiatric diagnoses (as defined in DSM-IV-TR) in addition to schizophrenia. [4] Have participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to Visit 1. [5] Have previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity. [6] Are patients for whom treatment with LY2140023 or placebo, as specified in this protocol, is relatively or absolutely clinically contraindicated.

Design outcomes

Primary

MeasureTime frame
to compare 3 doses of LY2140023 for the treatment of schizophrenia as assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI)

Countries

Korea, Republic of

Contacts

Public ContactJung Sik Lee

Medical Foundation Yong-in Mental Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026