Huperzine-A to Help With Mental Problems and the Inability to Care for Onself in Patients With Schizophrenia
Huperzine-A for Cognitive Dysfunction and Functional Status in Schizophrenia
1 other identifier
interventional
15
1 country
1
Brief Summary
Use Huperzine-A, a herbal supplement normally used for treatment of Alzheimer's disease, to potentially improve cognitive dysfunction (memory problems) and functional capacity (ability to perform common daily tasks such as cooking, bathing, telephone, shopping) in people with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 schizophrenia
Started Dec 2009
Shorter than P25 for phase_4 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedNovember 13, 2009
November 1, 2009
1 year
November 12, 2009
November 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MATRICS Consensus Cognitive Battery
First visit, 4 weeks, 8 weeks
Secondary Outcomes (1)
University of California Performance Skills Assessment-Brief (UPSA-B)
First visit, 8 weeks
Study Arms (1)
Huperzine A
EXPERIMENTAL200 micrograms (mcg) of HuperzineA taken twice daily.
Interventions
Huperzine A in 200 microgram (mcg) capsules taken twice daily for 8 weeks.
Eligibility Criteria
You may qualify if:
- age 19-59
- diagnosis of schizophrenia by MINI
- cognition score 1 standard deviation below published norms in controls
- clinically stable for 12 weeks i.e. on the same antipsychotic(s) for 8 weeks and stable dose for at least 4 weeks
- have no more than moderate severity rating on hallucinations, delusions formal thought disorder (BPRS), negative symptoms (PANSS\_N)
- minimal EPS (Simpson-Angus \<6)
- minimal depression (Calgary \<10)
- stable dose of other psychotropics (2 months)
- not pregnant.
You may not qualify if:
- history of active peptic ulcer disease within 1 year of screening
- clinically significant cardiac arrhythmia
- resting pulse less than 50
- active cancer (skin tumors other than melanoma are not excluded)
- history of clinically significant stroke
- current evidence or history in the past 2 years of epilepsy, focal brain lesion
- start of cholinesterase inhibitors/ cognitive enhancers (galantamine, rivastigmine, donepezil, vitamin E and memantine) within 2 months of screening, 8. use of medications with significant central nervous system anticholinergic activity within 2 months of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Veterans Affairs Nebraska Western Iowa Health Care System
Omaha, Nebraska, 68105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prasad R Padala, MD, MS
VA Office of Research and Development
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
November 12, 2009
First Posted
November 13, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2010
Study Completion
April 1, 2011
Last Updated
November 13, 2009
Record last verified: 2009-11