Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic/Efficacy

Completed · Phase 2

Conditions studied: Schizophrenia

In brief

Evaluate the safety and tolerability of multiple subcutaneous injections of various dosages of risperidone with clinically stable schizophrenia

Key facts

Study ID

NCT01677377

Run by

Indivior Inc.

People needed

45

Starts

2012-08-01

Expected to finish

2013-04-01

Last updated by the study team

2018-10-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female
• > 18 to < 65 years
• Diagnosis of paranoid, residual, or undifferentiated schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria
• Status: clinically stable subjects defined as subjects with no hospitalizations for acute exacerbations within 3 months of screening and screening total Positive and Negative Syndrome Scale (PANSS) score < 60
• Subjects who have given written informed consent

You may not qualify if…

• Subjects taking any risperidone sustained release formulation within the 60 days prior to study screening
• Subjects taking the following concurrent medication/over-the-counter products:
• Inducers or inhibitors of cytochrome P450 2D6 (CYP-2D6) within 14 days or 7 half - lives (whichever occurs last) prior to study screening
• Bupropion, chlorpheniramine, cimetidine, clomipramine, doxepin, or quinidine within 30 days prior to study screening
• Clozapine, phenothiazines, aripiprazole, haloperidol, or any other antipsychotic other than oral risperidone within 14 days prior to study screening
• Selective serotonin reuptake inhibitors (e.g., fluoxetine, paroxetine) or serotonin-norepinephrine reuptake inhibitors (e.g., venlafaxine, desvenlafaxine, duloxetine) within 30 days prior to study screening
• Opioids or opioid-containing analgesics within 14 days prior to study screening
• Medications, in addition to those listed above, which may be expected to significantly interfere with the metabolism or excretion of risperidone and/or 9-hydroxyrisperidone, that may be associated with a significant drug interaction with risperidone, or that may pose a significant risk to subjects' participation in the study
• Subjects with a history of cancer (with the exception of resected basal cell or squamous cell carcinoma of the skin) unless they have been disease free for >5 years
• Subjects with another active medical condition or organ disease that may either compromise subject safety and/or outcome evaluation of the study drug
• Subjects with evidence or history of a significant hepatic disorder that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the study drug. Individuals with acute hepatitis (including but not limited to B or C); or individuals with 1) total bilirubin >1.5x the upper limit of normal and/or 2) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) will be excluded
• Subjects with hepatitis C antibody and AST, ALT, or alkaline phosphatase >2x and total bilirubin >1.3 mg/dL will be excluded
• Subjects with a history of renal disease, or a creatinine clearance of less than 80 mL/min (as determined by the Cockcroft Gault formula)
• Subjects with an international normalized ratio >2.0 at screening
• Subjects with corrected QT interval (Bazett's - QTcB) >450 msec (male) or >470 msec (female) at screening. Subjects with a QTc above these levels due to a benign right bundle branch block can be included in the study at the discretion of the PI
• Subjects who are known to have AIDS or to be HIV positive
• Subjects with suicidal ideation with intent and plan (Columbia-Suicide Severity Rating Scale (C-SSRS) affirmative answers to questions 4 and 5 of the ideation section) or suicide attempts within the last six months as noted on the C-SSRS, or subjects with uncontrolled depression in the opinion of the investigator
• Subjects with known diagnosis of type 1 or 2 diabetes or subjects with Hemoglobin A1c >7.0 at screening
• Subjects who have participated in a clinical trial within 30 days prior to study screening
• Subjects who meet the DSM-IV-TR criteria for alcohol abuse or dependence within the last six months of screening

Where it is running

• Woodland International Research Group, Inc. — Little Rock, Alaska, United States
• Ocean View Psychiatric Health Facility — Long Beach, California, United States

Full record on ClinicalTrials.gov

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