Status:
COMPLETED
A Physical Dependence Study in Schizophrenia
Lead Sponsor:
Denovo Biopharma LLC
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether or not people with schizophrenia who take LY2140023 become physically dependent on it, and experience a series of symptoms such as craving to have the...
Detailed Description
This was a short-term, multicenter, placebo-controlled, randomized withdrawal study comparing LY2140023 with placebo in the treatment of outpatients with Diagnostic and Statistical Manual of Mental Di...
Eligibility Criteria
Inclusion
- Clinical diagnosis of schizophrenia
- Female participants of childbearing potential must test negative for pregnancy at study entry and agree to use a single, effective, medically acceptable method of birth control
- Participants must require a modification of antipsychotic medication or the initiation of antipsychotic medication, as indicated by their present clinical psychiatric status and/or treatment tolerability as outpatients
- Participants must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required, and be willing to perform all study procedures
- Participants must be able to understand the nature of the study and have given their own informed consent
Exclusion
- Have a Clinical Global Impression-Severity Scale (CGI-S) score \>4 at study entry
- Have any other psychiatric diagnoses in addition to schizophrenia
- Participants who have a history of inadequate clinical response to antipsychotic treatment for schizophrenia
- Participants who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses \>200 mg daily within 12 months prior to study entry, or who have received any clozapine at all during the month before study entry
- Participants who are actively suicidal
- Female participants who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study
- Have known, uncorrected, narrow-angle glaucoma
- Participants who have had electroconvulsive therapy (ECT) within 3 months of study entry or who will have ECT at any time during the study
- Participants with known medical history of human immunodeficiency virus positive (HIV+) status
- Participants who test positive for Hepatitis C virus antibody or Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody
- Participants with current or a history of seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
- Participants with a corrected QT interval (Bazett's; QTcB) \>450 milliseconds (msec) (male) or \>470 msec (female) at study entry (based on the central vendor's electrocardiogram \[ECG\] overread)
- Have previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity
- Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product for unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01452919
Start Date
November 1 2011
End Date
September 1 2012
Last Update
September 14 2022
Active Locations (10)
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1
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.
Oakland, California, United States, 94612
2
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.
San Diego, California, United States, 92123
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.
Torrance, California, United States, 90502
4
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.
North Miami, Florida, United States, 33161