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.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39433

Enrollment

219

Registered

2008-07-08

Start date

2011-12-05

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression melancholy

Interventions

The intervention will consist of TCCCL and/or Duloxetine.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 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, *dementia *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.

Design outcomes

Primary

Measure	Time frame
Primary study parameters will be effectiveness on severity of depression (measured by the PHQ9.	—

Secondary

Measure	Time frame
Secondary study parameters will be to establish cost effectiveness in terms of QALY as measured by EuroQol-5 and SF-36 and costs measured by TIC-P; and to establish improvement on pain in terms of BPI.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)