Phase 3
N=123
A Physical Dependence Study in Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01452919 ↗Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Maximum 3-Day Moving Average (MA) of the Discontinuation Symptom Checklist-Modified Rickels Total Score — 13.23; 11.50 units on a scale — p=0.170
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LY2140023 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Denovo Biopharma LLC
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum 3-Day Moving Average (MA) of the Discontinuation Symptom Checklist-Modified Rickels Total Score |
13.23; 11.50 | 0.170 |
| SECONDARY Change From Randomization up to Week 2 in the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) Total Score |
-0.7; 0.0; -0.9; -0.5; -0.8; -0.6 | 0.109 |
| SECONDARY Change From Randomization to Week 2 in Barnes Akathisia Scale (BAS) Global Score |
-0.0; -0.0 | 0.762 |
| SECONDARY Change From Randomization to Week 2 in Simpson-Angus Scale (SAS) Total Score |
-0.0; 0.0 | 0.506 |
| SECONDARY Change From Randomization to Week 2 in Abnormal Involuntary Movement Scale (AIMS) Total Score |
0.0; -0.0 | 0.515 |
| SECONDARY Percentage of Participants With Suicidal Behaviors and Ideations Measured Using the Columbia Suicide Severity Rating Scale (C-SSRS) During Open-Label Treatment Period |
1.6; 0.0 | — |
| SECONDARY Percentage of Participants With Suicidal Behaviors and Ideations Measured Using the Columbia Suicide Severity Rating Scale (C-SSRS) During Double-Blind Randomized Treatment Period |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Randomization to Week 2 in Clinical Global Impression-Severity Scale (CGI-S) |
-0.2; -0.0 | 0.966 |
| SECONDARY Change From Randomization to Week 2 in Brief Psychiatric Rating Scale (BPRS) Total Scores |
-2.20; -1.28 | 0.895 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01452919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.