HDAC Inhibitor Augmentation to Clozapine

• Status: Withdrawn
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The main goal of this pilot study is to test the extent to which adjunctive treatment with the histone deacetylase (HDAC) inhibitor vorinostat improves brain plasticity and cognition in a pilot placebo-controlled trial in patients with schizophrenia who are on clozapine.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Clozapine; Histone Deacetylase Inhibitors; Vorinostat

Criteria

Inclusion Criteria:

• Diagnosed with DSM-5 Schizophrenia

• Receiving stable dose pf clozapine (≥ 300 mg per day) for at least 6 months before entering the study

Exclusion Criteria:

• Taking specific psychotropic medications (lamotrigine and valproic acid)

• Current or recent (12-months) substance use or induced disorder

• History of significant neurological or medical disorders

• Intellectual disability

• Known contraindications to the administration of vorinostat per product labeling

• Women currently pregnant, planning to become pregnant, or receiving hormone therapy and refusing any form of birth control