Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048
研究概览
简要总结
This is a pilot study of pregnenolone as an augmentation treatment for schizophrenia. The goal of this placebo-controlled study is to provide preliminary efficacy data for potential pregnenolone effects on cognitive symptoms and negative symptoms in patients with schizophrenia. Depressive symptoms and positive symptoms will also be assessed.
详细描述
See brief summary
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age, any ethnic group, either sex
- •Diagnostic and Statistical Manual, 4th edition (DSM IV) diagnosis of schizophrenia or schizoaffective disorder
- •Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process.
- •Patient cohort enriched for moderate to severe cognitive symptoms (composite Brief Assessment of Cognition in Schizophrenia (BACS) score 0-3 SD below the mean).
- •No change in antipsychotic for 8 weeks or longer. No change in antipsychotic dose for 4 weeks or longer.
- •No change in anticholinergic, benzodiazepine, or mood stabilizer medications for 4 weeks or longer.
- •No anticipated need to alter any of the above medications (antipsychotics, anticholinergics, benzodiazepines, or mood stabilizers) for the 10-week duration of the study.
排除标准
- •Unstable medical illness or neurologic illness (seizures, cerebrovascular accident); history of prostate, breast, uterine, or ovarian cancer.
- •Use of oral contraceptives or other hormonal supplementation such as estrogen.
- •Other concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
- •Active expression of suicidal or homicidal ideation.
- •Comorbid substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.
- •Female patients who are pregnant or breast-feeding.
- •Known allergy to study medication.
- •Drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc) will be excluded as suggested by the Federal Drug Administration (FDA); patients taking these agents will not be eligible for this study.
研究组 & 干预措施
1
Pregnenolone
干预措施: Pregnenolone (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Score on the Scale for the Assessment of Negative Symptoms (SANS), p=0.048
时间窗: SANS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
The SANS assesses negative symptoms in schizophrenia. The SANS consists of 21 clinical interview questions assessing negative symptoms of schizophrenia. Each question is rated on a scale of 0 (no symptoms) to 7 (severe symptoms).
Mean Change of Z-scores on the Brief Assessment of Cognition in Schizophrenia (BACS)
时间窗: Change in composite BACS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
时间窗: Change in composite MATRICS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward)
The MATRICS is a battery for the assessment of cognitive symptoms in patients with schizophrenia. Composite T-scores are calculated (T-score ranges are -20 to +80, and are normed on gender and age). Higher scores are indicative of better cognitive performance, lower scores are indicative of poorer cognitive performance.
次要结局
- Clinical Global Impression Scale (CGI-I)(CGI-I scores at 8 weeks post-randomization (at least 4 weeks; last observation carried forward))
- Mean Score on the Positive and Negative Symptom Scale (PANSS)(Change in PANSS scores at baseline and 8 weeks post-randomization (at least 4 weeks; last observation carried forward))
- Mean Score Change in Calgary Depression Scale for Schizophrenia (CDSS)(Change in CDSS scores at baseline and 8 weeks (at least 4 weeks; last observation carried forward))