Pharmacotherapy for Minor Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 3
- 主要终点
- Efficacy Assessed Using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)
研究概览
简要总结
This 6-month study will compare the effectiveness of citalopram (Celexa®), hypericum (St. John's Wort), and placebo for the treatment of minor depression.
详细描述
Minor depression is highly prevalent, causes substantial morbidity and disability, presents a serious risk factor for the development of major depressive disorder, yet is under recognized and under treated. Researchers have determined that patients with minor depression frequently seek treatment from general practitioners and are often treated with prescription antidepressants. There is a need to evaluate the effectiveness of St. John's Wort in the management of minor depression. If the proposed study demonstrates the efficacy of St. John's Wort and/or citalopram, it will suggest treatment paradigms that can be tested and applied in primary care settings.
Subjects participated in a 12-week double-blind randomized study comparing St. John's Wort, citalopram, and placebo. Subjects were recruited through clinical referrals and community advertising. Data were obtained at the baseline visit (just prior to randomization) and at postrandomization visits conducted at 2-week intervals for the next 12 weeks, for a modified intent-to-treat sample consisting of all 73 subjects with at least 1 post-randomization visit (evaluable sample).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minor Depression symptoms for at least 6 months
- •Endorse one of the DSM-IV "A" criteria for MDD and at least one other symptom of MDD or endorse both of the "A" criteria for MDD
- •Global Assessment of Functioning (GAF) score < 70
- •Short form health survey (SF-36) social functioning score <= 75% or an emotional role functioning score <= 67%
- •HAM-D-17 score 10-17, inclusive
- •Minor depression symptoms for at least 6 months
排除标准
- •Major depressive disorder (MDD) or dysthymia within the past year or in partial remission of MDD
- •At least a 12-week course of either citalopram at a minimum or 40 mg/day or St. John's Wort at a minimum of 900 mg/day during the current episode of depression
- •Previous intolerance to either citalopram or St. John's Wort or history of nonresponse to either citalopram at a minimum of 40 mg/day or St. John's Wort at a minimum of 900 mg/day for at least 12 weeks
- •Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease
- •Uncontrolled seizure disorder
- •The following DSM-IV diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last year or patients with a positive urine drug screen; schizophrenia; delusional disorder; psychotic disorders not elsewhere classified; bipolar disorder; bereavement; adjustment disorder; antisocial personality disorder; panic disorder, social phobia, generalized anxiety disorder (GAD), or obsessive compulsive disorder (OCD). Patients may have a lifetime diagnosis of an anxiety disorder as long as it is not current.
- •Mood-congruent or mood-incongruent psychotic features
- •Psychotropic drugs
- •Hypothyroidism
- •Investigational psychotropic drugs within the last year
- •Positive toxicology screen
- •Medications metabolized by the CYP3A4 system, where induction of this system poses a risk to the medical stability of the patient
- •Pregnancy or refusal to use a medically accepted method of contraception
- •Serious suicide or homicide risk
- •Psychotherapy beginning less than 3 months ago
研究组 & 干预措施
citalopram
Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
干预措施: Citalopram (Drug)
St. John's Wort
Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.
干预措施: St. John's Wort (Drug)
Placebo
Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
干预措施: Placebos (Drug)
结局指标
主要结局
Efficacy Assessed Using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)
时间窗: Change from Baseline to Week 12
We expect that subjects with minor depression treated for 12 weeks with St. John's Wort or citalopram will have significantly greater reduction in depressive symptom severity than those treated with placebo. This will be measured by blind ratings on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C) which has a total score range from 0 to 84 with 0 being not depressed at all and 84 being the most depressed. The change will be calculated by subtracting the Week 12 score from the Baseline score.
Number of Adverse Events (Physical Symptoms) Emerging or Worsening During 12 Weeks of Treatment
时间窗: Change from Baseline to Week 12
We expect that subjects treated for Minor Depression for 12 weeks with either St. John's Wort or citalopram will have similar safety profiles to subjects treated with placebo, and will not differ by more than 20% in rates of adverse side effects (e.g., nausea, headache, insomnia, hypersomnia, diarrhea) from subjects treated with placebo. This was measured by the number of adverse events (physical symptoms) emerging or worsening during 12 weeks of treatment.
次要结局
未报告次要终点
研究者
Andrew A. Nierenberg, MD
Director Bipolar Clinic and Research Program
Massachusetts General Hospital