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

Brief Title

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

Official Title

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

Brief 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).
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

To Evaluate the Safety of Metyrosine (Demser®) for the Treatment of Psychosis in Patients With VCFS

Secondary Outcome

 To Evaluate the Efficacy of Metyrosine (Demser®) for the Treatment of Psychosis in Patients With VCFS

Condition

Velo-cardio-facial Syndrome

Intervention

Metyrosine

Study Arms / Comparison Groups

 Metyrosine
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

2

Start Date

June 2010

Completion Date

September 2011

Primary Completion Date

November 2010

Eligibility 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. -
      

Gender

All

Ages

16 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Robert J Shprintzen, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01127503

Organization ID

09-MET-101


Responsible Party

Sponsor

Study Sponsor

Bausch Health Americas, Inc.


Study Sponsor

Robert J Shprintzen, PhD, Principal Investigator, Upstate Medical University


Verification Date

November 2019