Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome
| Status: | Terminated |
|---|---|
| Conditions: | Other Indications, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 16 - 65 |
| Updated: | 5/10/2018 |
| Start Date: | June 2010 |
| End Date: | September 2011 |
A Double-Blind, Placebo-Controlled, Multi-Center, Randomized Trial of the Safety and Efficacy of Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velo-Cardio-Facial Syndrome
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).
the safety, steady-state pharmacokinetics, and efficacy of metyrosine (Demser®) for the
treatment of psychosis in patients with velocardiofacial syndrome (VCFS).
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. -
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