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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Huperzine A

200 micrograms (mcg) of HuperzineA taken twice daily.

Group Type EXPERIMENTAL

Huperzine A

Intervention Type DRUG

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

Interventions

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Huperzine A

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

Intervention Type DRUG

Other Intervention Names

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HupA Huperzine-A Huperzia serrata

Eligibility Criteria

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Inclusion Criteria

1. age 19-59
2. diagnosis of schizophrenia by MINI
3. cognition score 1 standard deviation below published norms in controls
4. clinically stable for 12 weeks i.e. on the same antipsychotic(s) for 8 weeks and stable dose for at least 4 weeks
5. have no more than moderate severity rating on hallucinations, delusions formal thought disorder (BPRS), negative symptoms (PANSS\_N)
6. minimal EPS (Simpson-Angus \<6)
7. minimal depression (Calgary \<10)
8. stable dose of other psychotropics (2 months)
9. not pregnant.

Exclusion Criteria

1. history of active peptic ulcer disease within 1 year of screening
2. clinically significant cardiac arrhythmia
3. resting pulse less than 50
4. active cancer (skin tumors other than melanoma are not excluded)
5. history of clinically significant stroke
6. current evidence or history in the past 2 years of epilepsy, focal brain lesion
7. 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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No