An 8-week Open-Label Flexible-Dose Study Of Desvenlafaxine as Monotherapy In The Treatment Of Dysthymia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Montgomery-Åsberg Depression Rating Scale
研究概览
简要总结
This multi-centred study will be conducted at two centres. The design will be an open label, flexible-dose study. This investigation will evaluate the efficacy of Desvenlafaxine monotherapy for patients who meet diagnostic criteria for dysthymia.
详细描述
Primary objective: To investigate the efficacy, safety, and tolerability of open-label desvenlafaxine monotherapy in dysthymic subjects.
Secondary objectives: To evaluate the efficacy of desvenlafaxine on clinical measures relating to improvement of depressive symptoms, quality of life and occupational functioning.
It is hypothesized that Dysthymic subjects will show significant improvement in depressive symptoms after 8 weeks of treatment with desvenlafaxine. There will be significant improvement in measures of quality of life and stress coping at end of treatment, compared to Baseline. There will also be significant improvement in measures of occupational functioning at end of treatment, compared to Baseline.
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
- •Male and female patients between 18-65 years.
- •Primary diagnosis of Dysthymic Disorder, as defined by DSM-IV criteria (300.4).
- •MADRS score ≥15 at Screening and Baseline.
- •Supportive therapy, and use of zopiclone for sleep and low-dose benzodiazepines on an as needed basis for anxiety, is allowed at any time.
- •Written informed consent
排除标准
- •Co-morbid diagnosis of any other Axis I disorders (other than anxiety disorders such as Generalized Anxiety Disorder, Social Anxiety Disorder and Post-traumatic Stress Disorder, provided that Dysthymic Disorder is currently the diagnosis).
- •Meet DSM-IV criteria for a current episode of major depression within two months prior to screening or who have received treatment for a major depressive episode within six months prior to screening.
- •Substance abuse or dependence including alcohol, within 6 months prior to screening.
- •Patients on the following prohibited treatments:
- •Psychotropics such as other SSRIs, other SNRIs, lithium, sibutramine, tramadol, St. John's Wort, within 2 weeks of randomization
- •Agents that impact significantly on serotonin metabolism (e.g. MAOIs, tryptophan, triptans) within 2 weeks of randomization
- •Have received physical therapies for depression (e.g. ECT, rTMS) within the 3 months prior to randomization.
- •Previous non-response to a therapeutic trial of desvenlafaxine (at least 50 mg/day for 2 months).
- •Clinically significant abnormalities in hematology, clinical chemistry, urinalysis or ECG at the screening visit, as judged by the Principal Investigator.
- •Presence of medical or psychiatric condition deemed by the Investigator to interfere with study procedures or endpoint data.
研究组 & 干预措施
Single-arm study
Desvenlafaxine 50mg/day Desvenlafaxine 100mg/day
干预措施: Desvenlafaxine (Drug)
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale
时间窗: 8 Weeks
次要结局
- Clinical Global Impression Scale(8 Weeks)
- Health and Work Performance Questionnaire(Baseline, Week 8)
- Survey of Coping Profiles Endorsed(Baseline, Week 4, Week 8)
- Work Productivity and Activity Impairment Questionnaire(Baseline, Week 8)
- Sheehan Disability Scale(Baseline, Week 4, Week 8)
- Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Scale Quality of Life Enjoyment and Satisfaction Questionnaire(Baseline, Week 4, Week 8)
- Perceived Stress Scale(Baseline, Week 8)
- Quick Inventory of Depressive Symptomatology(Baseline, Week 4, Week 8)
研究者
Arun Ravindran
Principal Investigator
Centre for Addiction and Mental Health