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A Physical Dependence Study in Schizophrenia

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ClinicalTrials.gov Identifier: NCT01452919
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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 drug when they stop using it.

This trial consists of two phases: An open-label phase consisting of up to 4 weeks and a double-blind phase consisting of up to 3 weeks.


Condition or disease Intervention/treatment Phase
Schizophrenia Drug: LY2140023 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Short-Term, Multicenter, Placebo-Controlled, Randomized Withdrawal Study of LY2140023 Monohydrate in Patients With DSM-IV-TR Schizophrenia
Study Start Date : November 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: LY2140023/LY2140023

Open label phase: 40 milligram (mg) LY2140023 administered orally; given twice daily for up to 4 weeks. At the discretion of the investigator, dose may be adjusted one time to 80 mg. 80 mg dose may be adjusted back to 40 mg one time. Current dose level at randomization will remain constant through the double blind phase.

Double blind phase: 40 mg or 80 mg LY2140023 administered orally; given twice daily for up to 3 weeks.

Drug: LY2140023
Administered orally
Other Name: pomaglumetad methionil

Placebo Comparator: LY2140023/Placebo

Open label phase: 40 mg LY2140023 administered orally; given twice daily for up to 4 weeks. At the discretion of the investigator, dose may be adjusted one time to 80 mg. 80 mg dose may be adjusted back to 40 mg one time.

Double blind phase: placebo administered orally; given twice daily for up to 3 weeks.

Drug: LY2140023
Administered orally
Other Name: pomaglumetad methionil

Drug: Placebo
Administered orally




Primary Outcome Measures :
  1. Maximum Discontinuation Symptom Checklist-Modified Rickels Total Score [ Time Frame: Randomization up to 3 weeks ]

Secondary Outcome Measures :
  1. Change from Randomization up to 3 Weeks in the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) [ Time Frame: Randomization, up to 3 weeks ]
  2. Change from randomization up to 3 weeks in Barnes Akathisia Scale (BAS) [ Time Frame: Randomization, up to 3 weeks ]
  3. Change from randomization up to 3 weeks in Simpson-Angus Scale (SAS) [ Time Frame: Randomization, up to 3 weeks ]
  4. Change from randomization up to 3 weeks in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Randomization, up to 3 weeks ]
  5. Number of participants with suicidal behaviors and ideations measured using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Randomization up to 3 weeks ]
  6. Change from randomization up to 3 weeks in Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: Randomization, up to 3 weeks ]
  7. Change from randomization up to 3 weeks in Brief Psychiatric Rating Scale (BPRS) total scores [ Time Frame: Randomization, up to 3 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of schizophrenia
  • Female patients of childbearing potential must test negative for pregnancy at study entry and agree to use a single, effective, medically acceptable method of birth control
  • Patients 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
  • Patients 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
  • Patients must be able to understand the nature of the study and have given their own informed consent

Exclusion Criteria:

  • Have a Clinical Global Impression-Severity Scale (CGI-S) score >4 at study entry
  • Have any other psychiatric diagnoses in addition to schizophrenia
  • Patients who have a history of inadequate clinical response to antipsychotic treatment for schizophrenia
  • Patients 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
  • Patients who are actively suicidal
  • Female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study
  • Have known, uncorrected, narrow-angle glaucoma
  • Patients who have had electroconvulsive therapy (ECT) within 3 months of study entry or who will have ECT at any time during the study
  • Patients with known medical history of human immunodeficiency virus positive (HIV+) status
  • Patients who test positive for Hepatitis C virus antibody or Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody
  • Patients 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
  • Patients 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452919


Locations
United States, California
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
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
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
United States, Florida
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
United States, Louisiana
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.
Lake Charles, Louisiana, United States, 70629
United States, Mississippi
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.
Flowood, Mississippi, United States, 39232
United States, Pennsylvania
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.
Philadelphia, Pennsylvania, United States, 19139
United States, Washington
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.
Bellevue, Washington, United States, 98007
Greece
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.
Haidari, Greece, 12462
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.
Tripoli, Greece, 22100
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01452919     History of Changes
Other Study ID Numbers: 14326
H8Y-MC-HBDF ( Other Identifier: Eli Lilly and Company )
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: October 2012

Keywords provided by Eli Lilly and Company:
schizophrenia, LY2140023, pomaglumetad methionil

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders