Huperzine-A to Help With Mental Problems and the Inability to Care for Onself in Patients With Schizophrenia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by VA Nebraska Western Iowa Health Care System.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
VA Nebraska Western Iowa Health Care System
Collaborator:
American Legion of Iowa Foundation
Information provided by:
VA Nebraska Western Iowa Health Care System
ClinicalTrials.gov Identifier:
NCT01012830
First received: November 12, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Schizophrenia Dementia |
Drug: Huperzine A |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Huperzine-A for Cognitive Dysfunction and Functional Status in Schizophrenia |
Resource links provided by NLM:
Further study details as provided by VA Nebraska Western Iowa Health Care System:
Primary Outcome Measures:
- MATRICS Consensus Cognitive Battery [ Time Frame: First visit, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- University of California Performance Skills Assessment-Brief (UPSA-B) [ Time Frame: First visit, 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
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.
Eligibility| Ages Eligible for Study: | 19 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012830
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012830
Contacts
| Contact: Daniel A Ramirez, BS | 800-451-5796 ext 4036 | Daniel.Ramirez@va.gov |
Locations
| United States, Nebraska | |
| Veterans Affairs Nebraska Western Iowa Health Care System | Not yet recruiting |
| Omaha, Nebraska, United States, 68105 | |
| Contact: Daniel A Ramirez, BS 800-451-5796 ext 4036 Daniel.Ramirez@va.gov | |
| Principal Investigator: Prasad R Padala, MD, MS | |
Sponsors and Collaborators
VA Nebraska Western Iowa Health Care System
American Legion of Iowa Foundation
Investigators
| Principal Investigator: | Prasad R Padala, MD, MS | Department of Veterans Affairs |
More Information
No publications provided
| Responsible Party: | Prasad R. Padala, M.D., VA Nebraska Western Iowa Health Care System |
| ClinicalTrials.gov Identifier: | NCT01012830 History of Changes |
| Other Study ID Numbers: | 636-631 |
| Study First Received: | November 12, 2009 |
| Last Updated: | November 12, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by VA Nebraska Western Iowa Health Care System:
|
Schizophrenia Cognitive Disorders Dementia Huperzine A HupA |
Additional relevant MeSH terms:
|
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features Huperzine A Central Nervous System Agents Cholinergic Agents Cholinesterase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Neuroprotective Agents Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015