Schizophrenia Clinical Trial
Official title:
HDAC Inhibitor Augmentation to Clozapine
Verified date | February 2019 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2019 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Safety of vorinostat measured by number of adverse events | 10 weeks | |
Primary | Change in clinical cognitive symptoms during adjunctive vorinostat therapy in schizophrenia patients treated with clozapine | Participants will be given a cognitive test to assess executive function and speed. | Baseline, Visit 4 (end of first intervention group/week 4), Visit 7 (end of study/10 weeks) |
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