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

Schizophrenia Clinical Trial

Official title:

Huperzine-A for Cognitive Dysfunction and Functional Status in Schizophrenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01012830
• Other study ID #: 636-631
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 12, 2009
• Last updated: November 12, 2009
• Start date: December 2009
• Est. completion date: April 2011

Study information

• Verified date: November 2009
• Source: VA Nebraska Western Iowa Health Care System
• Contact: Daniel A Ramirez, BS
• Phone: 800-451-5796
• Email: Daniel.Ramirez[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 59 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
United States	Veterans Affairs Nebraska Western Iowa Health Care System	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
VA Nebraska Western Iowa Health Care System	American Legion of Iowa Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MATRICS Consensus Cognitive Battery		First visit, 4 weeks, 8 weeks	No
Secondary	University of California Performance Skills Assessment-Brief (UPSA-B)		First visit, 8 weeks	No