Huperzine-A to Help With Mental Problems and the Inability to Care for Onself in Patients With Schizophrenia

Sponsor

VA Nebraska Western Iowa Health Care System (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT01012830

Collaborator

American Legion of Iowa Foundation (Other)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Dementia	Drug: Huperzine A	Phase 4

Detailed Description

HupA, an alkaloid initially identified from the Chinese herbal medicine Huperia serrata, is a potent reversible acetyl cholinesterase (AChE) inhibitor with additional unique properties including NMDA-receptor antagonist properties, neuroprotective and antioxidant effects. In animal studies, HupA was shown to possess greater inhibitory, longer-lasting, and more selective effects on AChE activity than donepezil. In clinical studies HupA improved memory, mood, and activities of daily living in patients with Alzheimer's dementia. Adverse effects have been reported at a very low rate in all the clinical trials, and are mainly cholinergic, such as dizziness, nausea, gastrointestinal symptoms, headaches and depressed heart rate. Thus, HupA is an attractive option which may have beneficial effects not only on cognitive but also functional domains of schizophrenia.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Huperzine-A for Cognitive Dysfunction and Functional Status in Schizophrenia

Study Start Date :

Dec 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2010

Anticipated Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Huperzine A 200 micrograms (mcg) of HuperzineA taken twice daily.	Drug: Huperzine A Huperzine A in 200 microgram (mcg) capsules taken twice daily for 8 weeks. Other Names: HupA Huperzine-A Huperzia serrata

Arm

Intervention/Treatment

Experimental: Huperzine A

200 micrograms (mcg) of HuperzineA taken twice daily.

Drug: Huperzine A

Huperzine A in 200 microgram (mcg) capsules taken twice daily for 8 weeks.

Other Names:

HupA

Huperzine-A

Huperzia serrata

Outcome Measures

Primary Outcome Measures

MATRICS Consensus Cognitive Battery [First visit, 4 weeks, 8 weeks]

Secondary Outcome Measures

University of California Performance Skills Assessment-Brief (UPSA-B) [First visit, 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.