WithdrawnEarly Phase 1

HDAC Inhibitor Augmentation to Clozapine

Stopped: PIs were unable to recruit any participants

0Started 2017-04

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Timeframe: 10 weeks

Change in clinical cognitive symptoms during adjunctive vorinostat therapy in schizophrenia patients treated with clozapine

Timeframe: Baseline, Visit 4 (end of first intervention group/week 4), Visit 7 (end of study/10 weeks)

Trial details

NCT IDNCT03263533

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02

View on ClinicalTrials.gov More Schizophrenia trials