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临床试验/NCT04507555
NCT04507555招募中不适用

Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy

PD Dr. med. Thorsten Mikoteit8 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2020年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
190
试验地点
8
主要终点
rate of response to the antidepressant therapy at the end of week 4

研究概览

简要总结

In this study at the Solothurn Psychiatric Clinic, the investigators compare the effectiveness and tolerability of antidepressant pharmacotherapy in three groups. In the intervention group, the physician selects and doses the medication for depression based on a pharmacogenetic examination conducted by a clinical pharmacist. In the standard group, the treating physician selects and doses the antidepressant drug without the support of genetic testing, in accordance with current standard practice. If after the first week of hopsitalization no adjustment to a new antidepressant is necessary, the investigators will monitor the progress of these patients until they leave the clinic in an observational arm. The drugs used are all approved in Switzerland for the treatment of depression. Classification into the intervention or standard group is made randomly after the first week of hospitalisation, if the treating physician deems it necessary to change or readjust the antidepressant pharmacotherapy. The probability of allocation to one of the two study groups is 50%. All study participants will be hospitalized for at least five weeks and monitored until they leave the clinic. In total, it is planned to include and examine 95 patients each into the intervention and standard group.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years old
  • Diagnosis unipolar moderate or severe depressive episode or recurrent depressive disorder (ICD10: F32.1/32.2/33.1/33.2)
  • HAM-D17 ≥ 17

排除标准

  • Acute suicide risk
  • Psychotic symptomatology
  • Other acute serious psychiatric disorder other than depression
  • Excessive consumption of alcohol and/or drugs
  • Severe acute - or severe chronic somatic diseases
  • Pregnant / lactating women
  • Under current treatment with fluoxetine

结局指标

主要结局

rate of response to the antidepressant therapy at the end of week 4

时间窗: 28 days

response is determined as a reduction in the Hamilton Depression (HAM-D17) Scale score of at least 50 % of the baseline value

次要结局

  • Number of adverse events related to antidepressant pharmacotherapy(28 days)
  • Patient depression self-rating(28 days)
  • Remission rate(28 days)
  • Overall change in 17 item Hamilton rating scale for Depression (HAM-D17) from baseline to week 4(28 days)
  • Side effect measure (self-rated frequency, intensity and burden of side effects, FIBSER score)(28 days)
  • Time to response(28 days)
  • Time till discharge(assessed up to 3 month)

研究者

发起方
PD Dr. med. Thorsten Mikoteit
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

PD Dr. med. Thorsten Mikoteit

Deputy Head Physician Division Psychiatry

University of Basel

研究点 (8)

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