NCT01121211已完成2 期
Hormonal Factors in the Treatment of Anorexia Nervosa
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change From Baseline in Weight
研究概览
简要总结
The investigators are investigating whether a hormone that is naturally produced by the human body, called testosterone, can help improve weight, disordered eating, depression, and anxiety. The investigators hypothesize that testosterone will be a novel and effective endocrine-targeted therapy for patients with anorexia nervosa.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18- 45 years; if participating in the neuroimaging sub study, age 18-40
- •Meet DSM-IV criteria for AN (restricting or binge/purge type, BMI 15-17.5) OR meet criteria for sub-threshold AN, i.e., all DSM-IV criteria except that patients can have a BMI of <18.5 kg/m2 with or without amenorrhea.
- •Free T below the median for healthy women of reproductive age
- •All participants will be required to have a treatment team in place that consists of (at least) a primary care physician and a psychotherapist. Participants will need to have had regular contact with a primary care physician and be in an individual psychotherapy program. Participants will agree to continue with this treatment team and therapy throughout the active course of the study. If participants are taking psychotropic medications, the dose must be stable for 3 months before study entry
排除标准
- •Pregnant women or women of child bearing potential who are not using medically accepted means of contraception (to include oral contraceptive, patch or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy).
- •Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic
- •Serious suicide risk, substance use disorder active within last 6 months, bipolar I disorder, severe current depressive symptoms (indexed by HAM-D score >20 [excluding 2 eating/weight loss items related to the symptoms of AN]), or psychotic disorder
- •New psychotropic drug regimen, specifically a significant dose change or change in drug class, within the last 6 weeks. A study psychiatrist will assess whether PRN medications and dose changes are clinically significant enough to defer enrollment of specific potential study subjects.
- •Untreated hypothyroidism
- •If receiving estrogen therapy, including oral contraceptives or transdermal estrogen therapy, significant change in dose in the prior 3 months
- •Use of androgens or androgen precursors, including T, DHEA and methyl T, within 3 months
- •Any investigational psychotropic drug within the last 3 months
- •In the judgment of the study clinician, unlikely to be able to participate safely throughout the study period
- •Alanine aminotransferase (ALT) > 2x upper limit of normal
- •Creatinine >1.5x upper limit
- •Serum potassium < lower limit of normal
- •If participating in the sub study, unable to tolerate 1 hour in MRI; contraindication to MRI (such as implanted pacemaker, cerebral aneurysm clips, extensive orthopedic hardware instrumentation); gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection); history of psychosis by SCID
研究组 & 干预措施
Testosterone
Active Comparator
Testosterone x 24 weeks
干预措施: Testosterone (Drug)
Placebo
Placebo Comparator
Placebo x 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Weight
时间窗: Baseline, 24 Weeks
Weight in kilograms
Change From Baseline in Depression Symptom Severity
时间窗: Baseline, 24 weeks
Hamilton Depression Rating Scale (HAM-D) (Higher score = greater depression symptom severity; Score Range 0 - ≥ 23)
次要结局
未报告次要终点
研究者
Karen Klahr Miller, MD
Chief, Neuroendocrine Unit
Massachusetts General Hospital
研究点 (1)
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