Overview

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

Status:
Unknown status
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
VA Nebraska Western Iowa Health Care System
Collaborator:
American Legion of Iowa Foundation
Treatments:
Huperzine A
Criteria
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.