CTRI/2012/02/002411已完成2 期
A 12-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP COMPARATIVE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PYRIDOXAL 5’ -PHOSPHATE MONOHYDRATE IN THE TREATMENT OF TARDIVE DYSKINESIA IN PATIENTS WITH SCHIZOPHRENIA AND SCHIZOAFFECTIVE DISORDERS.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The primary outcome measure will be a reduction in the total AIMS score for items 1 through 7 (facial and oral movements, extremity movements and trunk movements) across treatment groups from baseline through to week 12.
研究概览
简要总结
This is a 12 week, randomized, double-blind, placebocontrolled, parallel group comparative study. Patients will be screened and if eligible will be randomized (Day 1) to receive either P5’-P at 1000 mg/day (2x 250 mg po b.i.d) or placebo (2x pills po b.i.d), beginning at Day 1 and continuing daily for 12 consecutive weeks (Day 85). Assessments for tardive dyskinesia will occur at screening [Day 1] (to determine eligibility) and week 2 [Day 15], week 4 [Day 29], week 8 [Day 57] and week 12 [Day 85].
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients must have signed an informed consent document indicating that they understand the purpose of the study, its objectives, and the expectations of participation in the study and that they agree to participate in the study.
- •2.Meet current diagnostic criteria for Schizophrenia (Disorganized [
- •10], Paranoid [295.30], or Residual [295.60]), or Schizoaffective Disorder [295.70] as defined by the DSM-IV for at least 3 months before screening.
- •3.Have been on a stable dose and regime of a LAI for at least 3 injection intervals or oral antipsychotic for at least 1 month prior to randomization and are expected to remain on this stable dose and regime throughout their participation in the study.
- •4.Meet current diagnostic criteria for Neuroleptic Induced Tardive Dyskinesia [333.82] as defined by the DSM-IV.
- •5.Scoring ≥3 (moderate) on item 8, the "severity of abnormal movements overall" section of the AIMS.
- •6.Score ≥3 (moderate) on at least one item, or ≥2 (mild) on at least 2 items, and an overall total score of ≥5 on items 1 through 7 (facial and oral movements, extremity movements and trunk movements) sections of the AIMS.
- •7.Female patients must be post-menopausal for at least 2 years or surgically sterile.
- •Women of childbearing potential must be using or agree to use a reliable form of contraception before entry into and during participation in the study.
- •Reliable contraception can include an oral or other hormonal contraceptive started at least 4 weeks prior to randomization, a barrier method such as condoms or a diaphragm used with spermicide, or an intrauterine device (IUD).
- •8.Patients must be capable of administering study medication themselves or will have assistance with the administration of the study medication consistently available throughout the study.
排除标准
- •1.Involuntarily committed to a psychiatric hospital or correctional facility.
- •2.A primary active DSM-IV diagnosis or co-morbid Axis 1 diagnosis other than schizophrenia or schizoaffective disorder.
- •3.PANSS Score than 120 at the screening visit.
- •4.Current medical diagnosis that which could confound the interpretation or evaluation of the indication under study (i.e. Parkinsons Disease, Huntingtons Chorea, Muscular Dystrophy, Tourettes Syndrome).
- •5.History of liver cirrhosis, chronic active hepatitis (known positive serum test within 6 months of enrollment) or severe liver dysfunction, or liver transaminase ≥3 times ULN at screening (or obtained within 30 days prior to screening visit) 6.History of malignancy during the last 5 years.
- •7.Pregnant or any woman of childbearing potential who is not using a reliable form of contraception (this can include an oral or other hormonal contraceptive started at least 4 weeks prior to randomization, a barrier method such as condoms or a diaphragm used with spermicide, or an intrauterine device (IUD)).
- •Women who have been post-menopausal for at least two years or who have undergone surgical sterilization are considered to be not of childbearing potential.
- •8.Any medical, such as unstable cardiovascular, respiratory, neurological, renal, hepatic, immunological or endocrine, or psychiatric condition which in the opinion of the investigator makes the patient an unsuitable candidate for the study.
- •9.History of any pre-existing gastrointestinal narrowing or inability to swallow the oral study medication whole with the aid of water.
- •11.Significant, ongoing alcohol or drug dependency within 3 months before screening as defined by the DSM-IV (nicotine will not be exclusionary).
- •12.Significant risk of suicide or violent behavior as clinically assessed by the investigator.
- •13.Participation in any other investigational drug or device study within 30 days of randomization.
- •14.Patients who have previously participated in this study.
结局指标
主要结局
The primary outcome measure will be a reduction in the total AIMS score for items 1 through 7 (facial and oral movements, extremity movements and trunk movements) across treatment groups from baseline through to week 12.
时间窗: From baseline through to week 12
次要结局
- •An AIMS score reduction (items 1-7) across arms over course of study amongst completers; determine whether the proportion of responders differs between treatment arms; a reduction in the AIMS score, items 1 - 7 total, across treatment arms.(From baseline through to Week 12 and Baseline compared to Week 12)
研究者
研究点 (1)
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