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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

August 10, 2009
February 28, 2013
March 2010
December 2012   (final data collection date for primary outcome measure)
MATRICS battery [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00963846 on ClinicalTrials.gov Archive Site
UPSA [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Huperzine for Cognitive and Functional Impairment in Schizophrenia
Huperzine for Cognitive and Functional Impairment in Schizophrenia

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: placebo
    matching pill placebo
  • Drug: huperzine 0.2 mg BID
    huperzine rising doses up to 0.2 mg BID
  • Drug: huperzine 0.4 mg BID
    huperzine rising doses up to 0.4 mg BID
  • Drug: huperzine 0.8 mg BID
    huperzine rising doses up to 0.8 mg BID
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: huperzine 0.2 mg BID
    Intervention: Drug: huperzine 0.2 mg BID
  • Experimental: huperzine 0.4 mg BID
    Intervention: Drug: huperzine 0.4 mg BID
  • Experimental: huperzine 0.8 mg BID
    Intervention: Drug: huperzine 0.8 mg BID
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00963846
Biomedisyn 200901, 3R41MH083436-01A1S1
No
Scott Woods, MD, Biomedisyn Corporation
Biomedisyn Corporation
Yale University
Principal Investigator: Scott W Woods, MD Biomedisyn Corporation
Biomedisyn Corporation
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP