NCT02231268已完成不适用
Observational Study Via Internet to Assess a 6-months Treatment With GLADEM
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 546
- 主要终点
- Change in Hamilton Depression Scale (HAMD-6)
研究概览
简要总结
- Evaluation of a 6-months treatment with Gladem
- Experiences with the internet for performing a postmarketing study (PMS) trial
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women at least 18 years old
- •De novo prescription of Gladem
- •Treatment with Gladem intended for at least 6 months
- •Depressive disorders
排除标准
- •Known hypersensitivity against sertraline
- •Concomitant treatment with monoamine oxidase (MAO)-inhibitors, selegiline, moclobemide (washout for at least 14 days necessary)
- •Concomitant treatment with other serotoninergic substances like tryptophan or fenfluramine
- •Instable epilepsy
- •According to product information (October 1998) Gladem prescription was possible with precautions in the following cases:
- •Patients with stable epilepsy
- •Patients with restricted liver functions
- •Suicidal patients
- •Patients in emotional state and marked sleeping disorders
- •According to product information (October 1998) Gladem should only be prescribed during pregnancy and lactation period, if the expected benefit was greater than the risk. Women of childbearing age should use Gladem only in combination with sufficient contraception.
研究组 & 干预措施
Depressive patients
干预措施: Gladem (Drug)
结局指标
主要结局
Change in Hamilton Depression Scale (HAMD-6)
时间窗: 3 months, 6 months
次要结局
- Global assessment of tolerability on a 4-point scale(up to 6 months)
- Number of responders(up to 6 months)
- Change in HAMD subscores(baseline, 6 months)
- Global assessment of compliance on a 4-point scale(up to 6 months)
- Global assessment of efficacy on a 4-point scale(up to 6 months)
- Clinical global impression score(up to 6 months)
- Number of patients with adverse drug reactions(up to 6 months)
研究者
相似试验
撤回
不适用
Efficacy of a Web-based Lifestyle Modification Program in Obese Patients With Cardiovascular Risk FactorsObesityNCT01664026Clínica Bazterrica
已完成
4 期
The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months TreatmentArthritis, RheumatoidNCT03855007Qilu Hospital of Shandong University400
已完成
不适用
Online Mindfulness-Based Cognitive Therapy in Depressed SampleModerate Depressive EpisodeMild Depressive EpisodeNCT05919875University of Warsaw170
已完成
3 期
Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye SyndromeSjogren's SyndromeLupus Erythematosus, SystemicArthritis, RheumatoidScleroderma, SystemicKeratoconjunctivitis SiccaNCT00025818Allergan290
招募中
不适用
Leveraging Telehealth to Improve Oral Health Among Cancer SurvivorsOral MucositisPeriodontal DiseasesCancerNCT06315855Georgetown University100