A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms

Denovo Biopharma

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: LY2140023; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01052103

13261

H8Y-MC-HBCO (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether LY2140023, when added to standard-of-care antipsychotic treatment, will improve negative symptoms.

Full description

The primary objective of this study was to test the hypothesis that treatment with LY2140023 compared to placebo, when added to a fixed dose of a standard of care (SOC) antipsychotic, would demonstrate significantly greater reduction of negative symptoms, as assessed by the 16-item Negative Symptom Assessment scale (NSA-16), in patients with schizophrenia. Patients included in this study were concurrently receiving 1 of 4 second generation antipsychotics (SGAs): aripiprazole, olanzapine, risperidone, or quetiapine.

Enrollment: 167 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of schizophrenia
• Participants must have been receiving monotherapy treatment for at least 3 months prior to study entry with one of 4 atypical antipsychotic medications (aripiprazole, olanzapine, risperidone, quetiapine)
• Disease symptoms must meet a certain range as assessed by the clinician
• Participants must have evidence of prominent negative symptoms of schizophrenia (for example blunted affect, emotional withdrawal, or motor retardation)
• Participants must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
• Participants must be able to understand the nature of the study and have given their informed consent

Exclusion criteria

• Participants who are actively suicidal
• Participants who are pregnant or nursing
• Participants who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
• Participants with uncorrected narrow-angle glaucoma, history of or current seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
• Participants with Parkinson's disease, psychosis related to dementia or related disorders
• Participants with known Human Immunodeficiency Virus positive (HIV+) status

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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167 participants in 2 patient groups, including a placebo group

LY2140023

Experimental group

Description:

40 mg/day, given orally twice daily (BID) as a 20-mg tablet. LY2140023 dosage was adjustable from 10 mg to 40 mg BID.

Treatment:

Drug: Standard of Care

Drug: LY2140023

Placebo

Placebo Comparator group

Description:

Placebo tablets to match LY2140023 tablets

Treatment:

Drug: Standard of Care

Drug: Placebo