NCT00963846已完成2 期
Huperzine for Cognitive and Functional Impairment in Schizophrenia
Biomedisyn Corporation1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- MATRICS battery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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 <
- •Calgary Depression Scale for Schizophrenia total score <
- •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.
- •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
- •Available informant knowledgeable about subject's current functioning.
- •Informed consent obtained from the subject prior to entry into the study.
排除标准
- •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.
- •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
- •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.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
huperzine 0.2 mg BID
Experimental
干预措施: huperzine 0.2 mg BID (Drug)
huperzine 0.4 mg BID
Experimental
干预措施: huperzine 0.4 mg BID (Drug)
huperzine 0.8 mg BID
Experimental
干预措施: huperzine 0.8 mg BID (Drug)
结局指标
主要结局
MATRICS battery
时间窗: 26 weeks
次要结局
- UPSA(26 weeks)
研究者
Scott Woods, MD
Consultant
Biomedisyn Corporation
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Huperzine-A to Help With Mental Problems and the Inability to Care for Onself in Patients With SchizophreniaSchizophreniaDementiaNCT01012830VA Nebraska Western Iowa Health Care System15
Enrolling By Invitation
不适用
Effects of Huperzine a on Presbycusis(Δ,kHz, DB,MMSE, AD)Cognitive ImpairmentTinnitusPresbycusisNCT03101722Zhijun Bao60
已完成
3 期
Molecular Hydrogen for Cognitive Function and Performance in ElderlyCognitive ImpairmentsAgingNCT02830854University of Novi Sad, Faculty of Sport and Physical Education13
已完成
早期 1 期
Effect of Huperzine A on Cognitive Function and Perception of Effort During ExerciseCognitive Enhancement During ExerciseNCT03445104St. Louis University15
终止
2 期
Effects of Huperzine A in Treatment of Moderate to Severe TBITraumatic Brain InjuryNCT01676311Spaulding Rehabilitation Hospital14