A Pilot Study of Treatment for Refractory Depression With Sequential Trials of Tranylcypromine, Tranylcypromine Plus Dextroamphetamine, Tranylcypromine Plus Triiodothyronine.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale (HAM-D)
研究概览
简要总结
This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.
详细描述
This pilot study will recruit 40 patients with Major Depression and a history of at least two failed prior adequate somatic treatments. In addition to usual physical work-up, all patients will have extensive thyroid testing, and then will receive standard dose Tranylcypromine (i.e., max. 60 mg/d). Non-remitters will have dose increased to max. 120 mg/d if tolerated. Non-remitters to high dose Tranylcypromine will then have Dextroamphetamine added with frequent blood pressure monitoring to max. 40 mg/d. Non-remitters will have Triiodothyronine added to the Tranylcypromine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Ages between 18-65
- •Major Depression
- •At least two prior ineffective antidepressant trials (at least 2 different mechanisms) or 1 inadequate ECT trial (at least 8 bilateral treatments)
- •Physically healthy
排除标准
- •Known Tranylcypromine allergy
- •Unable to follow tyramine-free diet
- •Known allergy, intolerance or prior addiction to any stimulant would preclude patient's inclusion in the Dextroamphetamine portion of the protocol
- •Current substance use disorder including alcohol)(past six months); ever dependent on stimulants would preclude Dextroamphetamine portion of the protocol
- •Unable or unwilling to discontinue antidepressants including OTC antidepressants such as St. John's Wort
- •History of psychosis, such as schizophrenia or psychotic depression; history of bipolar mania will be allowed if on adequate mood stabilizer
- •Suicidal ideation/activity that makes outpatient treatment unsafe, unless protocol can be conducted as inpatient
- •Current systolic BP > 149 or diastolic BP > 89 mm Hg (two readings); adequately treated hypertension is acceptable
- •Evidence of hypo- or hyperthyroidism
- •Pregnancy, lactation, refusal to use adequate birth control
研究组 & 干预措施
tranylcypromine
sequential tranylcypromine (TC) followed by TC + dextroamphetamine followed by TC + T3
干预措施: Tranylcypromine (Drug)
tranylcypromine
sequential tranylcypromine (TC) followed by TC + dextroamphetamine followed by TC + T3
干预措施: Dextroamphetamine (Drug)
tranylcypromine
sequential tranylcypromine (TC) followed by TC + dextroamphetamine followed by TC + T3
干预措施: Triiodothyronine (Drug)
结局指标
主要结局
Hamilton Depression Scale (HAM-D)
时间窗: up to 10 mos.
次要结局
- Beck Depression Inventory (BDI)(up to 10 mos.)
- Clinical Global Impression (CGI)(up to 10 mos.)
- Patient Global Impression (PGI)(up to 10 mos.)