Effectiveness and Cost-effectiveness of Transmural Collaborative care with Consultation Letter (TCCCL) and Duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: A randomized placebo-controlled Multi-Centre trial. TCC:PAINDIP. - Efficacy of Collaborative care and Duloxetine for major depressive disorder

GGZ Breburg Groep (Rijen)0 个研究点目标入组 219 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Patient type: Patients, male/female. Age range: 18 years or older. Patients that present themselves with major depressive disorder with concomitant pain symptoms of more than 6 weeks duration will be included.

•Patients with pain for which by diagnostic medical assessment a structural and continuing physical cause has been found in terms of tissue damage, illness or otherwise, that requires treatment, such as pain due to cancer or recent post traumatic pain, are excluded from the study and advised to seek such treatment. Other exclusion criteria are:
•*a PHQ-9 < 10 or a BPI score < 3,
•*alcohol use >3 units a day or drug abuse or dependence in the last 6 months, defined as current use of any hard drugs or cannabis
•*psychotic symptoms or use of antipsychotic medication that may influence perception of pain;
•*use of St John*s wort (Hypericum Perforatum),
•*pregnancy and breastfeeding,
•*inability to participate in case of too severe language barrier,
•*severe renal and liver dysfunction.
•* uncontrolled hypertension
•*Lastly, suicidal ideation is an exclusion criterion if this constitutes immediate danger and the need for crisis management according to the consulted psychiatrist. This will be measured with the suicidal ideation item of the PHQ-9. For this purpose, a suicide protocol is used in the study, defining degrees of suicide risk and prescribing necessary steps to be taken to advert such risk.

发起方

GGZ Breburg Groep (Rijen)