Huperzine for Cognitive and Functional Impairment in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Scott Woods, MD, Biomedisyn Corporation
ClinicalTrials.gov Identifier:
NCT00963846
First received: August 10, 2009
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

Huperzine is a natural plant product with procognitive properties in patients with Alzheimer's disease. Cognitive difficulties hamper functioning in schizophrenia as well. The present study will investigate whether huperzine improves cognition and functioning in patients with schizophrenia.


Condition Intervention Phase
Schizophrenia
Drug: placebo
Drug: huperzine 0.2 mg BID
Drug: huperzine 0.4 mg BID
Drug: huperzine 0.8 mg BID
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Huperzine for Cognitive and Functional Impairment in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Biomedisyn Corporation:

Primary Outcome Measures:
  • MATRICS battery [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • UPSA [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
matching pill placebo
Experimental: huperzine 0.2 mg BID Drug: huperzine 0.2 mg BID
huperzine rising doses up to 0.2 mg BID
Experimental: huperzine 0.4 mg BID Drug: huperzine 0.4 mg BID
huperzine rising doses up to 0.4 mg BID
Experimental: huperzine 0.8 mg BID Drug: huperzine 0.8 mg BID
huperzine rising doses up to 0.8 mg BID

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Psychiatric diagnosis of schizophrenia according to SCID-IV.
  2. Currently treated with an antipsychotic medication.
  3. Has tolerated current antipsychotic treatment adequately.
  4. Has received an adequate trial of antipsychotic (a least 3 months of at least 300 mg/d CPZ equivalent).
  5. Has been receiving current psychotropic medication (s) for at least 8 weeks.
  6. Has been receiving current doses of psychotropic medication (s) for at least 4 weeks.
  7. Has been clinically stable for at least 12 weeks.
  8. No more than moderate severity (4 on the 1-7 scale) on any PANSS positive item.
  9. No more than 15 on the total of PANSS negative symptom items.
  10. Simpson-Angus Scale total score <7.
  11. Calgary Depression Scale for Schizophrenia total score <11.
  12. Submaximal performance on at least one of the following MATRICS components (letter-number span <20 OR HVLT total <31 OR CPT d-prime < 3.47).
  13. Score > 1 SD below age-, gender-, and education-adjusted normal control mean on MATRICS composite
  14. Good general health with no additional diseases expected to interfere with the studies.
  15. Fluent in English.
  16. Age 18-55.
  17. Adequate visual and auditory acuity to allow neuropsychological testing.
  18. Able to ingest oral medication.
  19. Not pregnant or lactating (women of childbearing potential must use a medically accepted method of birth control).
  20. Onset of schizophrenia prior to age 45.
  21. Available informant knowledgeable about subject's current functioning.
  22. Informed consent obtained from the subject prior to entry into the study.

Exclusion Criteria:

  1. Poor reading skills (raw score on MATRICS Wechsler Test of Adult Reading < 6).
  2. History of systemic cancer within 5 years.
  3. Use of any investigational drugs within 30 days prior to the screening visit.
  4. Use of cholinesterase inhibitors (galantamine, rivastigmine, donepezil, or tacrine) within 4 weeks of screening.
  5. Any clinically significant laboratory test abnormality on screening tests (hematology, chemistry, urinalysis, EKG). Clinically significant LFT elevations will be defined as >2x the upper limit of normal.
  6. Any significant neurologic disease including Alzheimer's disease, parkinson's disease, stroke, huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of head injury with loss of consciousness for greater than one day within the past 5 years, or with residual deficits.
  7. Use of antihypertensive agents with frequent CNS side effects (e.g. clonidine, propranolol) within 4 weeks prior to the screening visit.
  8. Use of medications known to alter drug absorption or metabolism (e.g. probenecid, cimetidine, anti-fungal agents, erythromycin, rifampin, and anticonvulsants) within 4 weeks prior to the screening visit.
  9. History of peptic ulcer disease within 2 years.
  10. History of myocardial infarction, significant cardiovascular disease, or congestive heart failure within 6 months, history of hepatic or renal insufficiency, insulin-requiring diabetes or uncontrolled diabetes mellitus.
  11. Clinically significant cardiac arrhythmia, resting pulse less than 50.
  12. Present use or use in the 4 weeks prior to screening of anti-parkinsonian or anticholinergic medications (e.g. Sinemet, amantadine, bromocriptine, pergolide, selegiline, atropine, scopolamine, benztropine, trihexyphenidyl, hydroxyzine, diphenhydramine).
  13. Use of narcotic analgesics within 4 weeks prior to the screening visit.
  14. History of alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria).
  15. Receiving CYP 1A2 inhibitors such as certain SSRIs (all excluded in #4) cimetidine, methoxsalen, quinolones, furafylline, or moclobemide.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT00963846

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Biomedisyn Corporation
Yale University
Investigators
Principal Investigator: Scott W Woods, MD Biomedisyn Corporation
  More Information

No publications provided

Responsible Party: Scott Woods, MD, Consultant, Biomedisyn Corporation
ClinicalTrials.gov Identifier: NCT00963846     History of Changes
Other Study ID Numbers: Biomedisyn 200901, 3R41MH083436-01A1S1
Study First Received: August 10, 2009
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biomedisyn Corporation:
schizophrenia
cognition
functioning

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Huperzine A
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014