SchizophreniaPhase 2NCT00963846
Huperzine for Cognitive and Functional Impairment in Schizophrenia
A Phase 2 study testing huperzine 0.2 mg BID, huperzine 0.4 mg BID and huperzine 0.8 mg BID in people with Schizophrenia, run by Biomedisyn Corporation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- huperzine 0.2 mg BID, huperzine 0.4 mg BID and huperzine 0.8 mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Psychiatric diagnosis of schizophrenia according to SCID-IV.
- Currently treated with an antipsychotic medication.
- Has tolerated current antipsychotic treatment adequately.
- Has received an adequate trial of antipsychotic (a least 3 months of at least 300 mg/d CPZ equivalent).
- Has been receiving current psychotropic medication (s) for at least 8 weeks.
- Has been receiving current doses of psychotropic medication (s) for at least 4 weeks.
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- Has been clinically stable for at least 12 weeks.
- No more than moderate severity (4 on the 1-7 scale) on any PANSS positive item.
- No more than 15 on the total of PANSS negative symptom items.
- Simpson-Angus Scale total score <7.
- Calgary Depression Scale for Schizophrenia total score <11.
- 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).
- Score > 1 SD below age-, gender-, and education-adjusted normal control mean on MATRICS composite
- Good general health with no additional diseases expected to interfere with the studies.
- Fluent in English.
- Age 18-55.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Able to ingest oral medication.
- Not pregnant or lactating (women of childbearing potential must use a medically accepted method of birth control).
- Onset of schizophrenia prior to age 45.
- Available informant knowledgeable about subject's current functioning.
- Informed consent obtained from the subject prior to entry into the study.
Who cannot join
- Poor reading skills (raw score on MATRICS Wechsler Test of Adult Reading < 6).
- History of systemic cancer within 5 years.
- Use of any investigational drugs within 30 days prior to the screening visit.
- Use of cholinesterase inhibitors (galantamine, rivastigmine, donepezil, or tacrine) within 4 weeks of screening.
- 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.
- 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.
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- Use of antihypertensive agents with frequent CNS side effects (e.g. clonidine, propranolol) within 4 weeks prior to the screening visit.
- 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.
- History of peptic ulcer disease within 2 years.
- 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.
- Clinically significant cardiac arrhythmia, resting pulse less than 50.
- 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).
- Use of narcotic analgesics within 4 weeks prior to the screening visit.
- History of alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria).
- Receiving CYP 1A2 inhibitors such as certain SSRIs (all excluded in #4) cimetidine, methoxsalen, quinolones, furafylline, or moclobemide.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06519
About this study
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.
- Conditions
- Schizophrenia
- Being tested
- placebo, huperzine 0.2 mg BID, huperzine 0.4 mg BID, huperzine 0.8 mg BID
- Keywords
- schizophrenia, cognition, functioning
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
matching pill placebo
huperzine 0.2 mg BIDDrug
huperzine rising doses up to 0.2 mg BID
huperzine 0.4 mg BIDDrug
huperzine rising doses up to 0.4 mg BID
huperzine 0.8 mg BIDDrug
huperzine rising doses up to 0.8 mg BID
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| huperzine 0.2 mg BID | Experimental | Not described Receives: Drug: huperzine 0.2 mg BID |
| huperzine 0.4 mg BID | Experimental | Not described Receives: Drug: huperzine 0.4 mg BID |
| huperzine 0.8 mg BID | Experimental | Not described Receives: Drug: huperzine 0.8 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
MATRICS battery
Measured: 26 weeks
Secondary outcomes (1)
UPSA
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedisyn Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Scott Woods, MD, Biomedisyn Corporation
- Investigators
- Scott W Woods, MD, Principal investigator, Biomedisyn Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963846
- Sponsor's protocol ID
- Biomedisyn 200901
- Other IDs
- 3R41MH083436-01A1S1
- Status last verified
- Feb 2013
- First submitted
- 10 Aug 2009
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Huperzine for Cognitive and Functional Impairment in Schizophrenia
- ClinicalTrials.gov ID
- NCT00963846
- Acronym / sponsor ID
- Biomedisyn 200901
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, cognition, functioning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Biomedisyn CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| huperzine 0.2 mg BID | Experimental | Drug: huperzine 0.2 mg BID |
| huperzine 0.4 mg BID | Experimental | Drug: huperzine 0.4 mg BID |
| huperzine 0.8 mg BID | Experimental | Drug: huperzine 0.8 mg BID |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Psychiatric diagnosis of schizophrenia according to SCID-IV.
- Currently treated with an antipsychotic medication.
- Has tolerated current antipsychotic treatment adequately.
- Has received an adequate trial of antipsychotic (a least 3 months of at least 300 mg/d CPZ equivalent).
- Has been receiving current psychotropic medication (s) for at least 8 weeks.
Key exclusion criteria (15 listed)
- Poor reading skills (raw score on MATRICS Wechsler Test of Adult Reading < 6).
- History of systemic cancer within 5 years.
- Use of any investigational drugs within 30 days prior to the screening visit.
- Use of cholinesterase inhibitors (galantamine, rivastigmine, donepezil, or tacrine) within 4 weeks of screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebomatching pill placebo | Drug | placebo |
| huperzine 0.2 mg BIDhuperzine rising doses up to 0.2 mg BID | Drug | huperzine 0.2 mg BID |
| huperzine 0.4 mg BIDhuperzine rising doses up to 0.4 mg BID | Drug | huperzine 0.4 mg BID |
| huperzine 0.8 mg BIDhuperzine rising doses up to 0.8 mg BID | Drug | huperzine 0.8 mg BID |
Primary outcome
MATRICS battery
Time frame: 26 weeks
1 secondary outcome
UPSA
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott W Woods, MD principal investigator
Biomedisyn Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing huperzine 0.2 mg BID, huperzine 0.4 mg BID and huperzine 0.8 mg BID in people with Schizophrenia, run by Biomedisyn Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MATRICS battery (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2013.