Overview

Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome

Status:
Terminated
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
Summary
This is an exploratory clinical investigation. The objectives of this study are to evaluate the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the treatment of psychosis in patients with velocardiofacial syndrome (VCFS).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bausch Health Americas, Inc.
Valeant Pharmaceuticals International, Inc.
Treatments:
alpha-Methyltyrosine
Criteria
Key Inclusion Criteria:

1. Females of childbearing potential cannot be at risk of pregnancy during the study.

2. Genetically confirmed diagnosis of VCFS at the time of screening.

3. Must have one of the following Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition Text Revision (DSM-IV TR) diagnoses (applicable based upon clinical
assessments): schizophrenia, schizoaffective disorder, psychosis not otherwise
specified (NOS), bipolar disorder, or mood disorder with psychotic features.

4. A total PANSS composite score >65.

5. Willing to discontinue psychotropic medications. -

Key Exclusion Criteria:

1. Evidence of acute suicidality.

2. Known or observed clinically significant cardiovascular, pulmonary, renal, hepatic, or
gastrointestinal disorders; other clinically significant psychiatric/neurological and
sleep disorders by DSM-IV-TR criteria; endocrine, or hematological or metabolic
diseases.

3. Full scale IQ of less than 50.

4. Pregnancy.

5. Not using a reliable means of contraception.

6. Systolic blood pressure of ≤110 mm/Hg or ≥160 mm/Hg, diastolic blood pressure ≤60
mm/Hg or ≥90 mm/Hg, or has clinically symptomatic orthostatic changes.

7. QTcF > 450 msec, or PR > 250 msec, or QRS > 110 msec on ECG.

8. History of seizure disorder. -