Addition of Tiagabine to Second-Generation Antipsychotics in the Treatment of Recent-Onset Schizophrenia by Modification of Developmental Reorganization of the Prefrontal Cortex
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Neurocognitive Functions-Working Memory
研究概览
简要总结
The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease.
This study is funded by the National Institutes of Health.
详细描述
It is hypothesized that enhancement of GABA neurotransmission during the early course of the illness by tiagabine (Gabitril), a GABA transporter GAT-1-specific inhibitor and a FDA-approved anticonvulsant, will improve both clinical symptoms and working memory in schizophrenia. This improvement is postulated to be the result of tiagabine-mediated modification of the developmental synaptic pruning of prefrontal cortical circuitry. The occurrence of circuitry modification after tiagabine treatment will be assessed by the following independent methodologic approaches: MRI morphometric analysis of prefrontal gray matter volume and fMRI measurements of brain activity patterns during performance of tasks that probe working memory.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for the diagnosis of schizophrenia, with onset of psychotic symptoms within the past 3 years.
- •Currently on second-generation antipsychotics for at least 3 months.
- •Age 18-25, otherwise healthy.
排除标准
- •Diagnosis of schizoaffective disorder.
- •Has failed two or more clinically adequate antipsychotic trials.
- •History of seizures or any neurologic disorders.
- •Pregnant or nursing women.
- •Known HIV infection.
- •Actively suicidal.
- •History of any substance dependence.
- •Currently meets criteria for substance abuse/dependence.
- •Other MRI exclusion criteria per Radiology Department protocols.
研究组 & 干预措施
Antipsychotic plus study drug
Half of the subjects will receive the study medications in addition to their ongoing antipsychotic regimen.
干预措施: Tiagabine (Drug)
Antipsychotics plus placebo
Half of the subjects will receive placebo in addition to their antipsychotic regimen.
干预措施: Placebo (Drug)
结局指标
主要结局
Neurocognitive Functions-Working Memory
时间窗: Working memory will be assessed at baseline and at 6-month time point to see if working memory changes after 6 months compared to baseline measurement
Working memory will be assessed using the n-back working memory test
Neurocognitive Functions-Executive Function
时间窗: Executive function will be assessed at baseline and at 6-month time point to see if executive function changes after 6 months compared to baseline measure
Executive function, which is a complex form of working memory, will be assessed using the MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) battery
次要结局
- Clinical symptoms(Symptoms will be assessed at baseline and at 6-month time point to see if symptoms change after 6 months compared to baseline measures)
研究者
Tsung-Ung Wilson Woo
Assistant Professor of Psychiatry
Beth Israel Deaconess Medical Center