The objective of this study is to establish the (cost) effectiveness of transmural collaborative care including a Consultation Letter for the GP and duloxetine (TCCCL) versus Duloxetine in patients with depression that present themselves with (sub)…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters will be effectiveness on severity of depression
(measured by the PHQ9.
Secondary outcome
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.
Background summary
Patients with depression often present themselves with pain. Pain is a symptom
that occurs in up to 70% of depressed patients. The burden of pain in
depression is high for patients and doctors in terms of disability, welbeing
and use of medical care. However, treatment of pain in depressive patients has
until yet not received much attention. Therefore, in the proposed trial, three
modules for treatment of major depression with concomitant pain will be
evaluated in terms of (cost)effectiveness.
Study objective
The objective of this study is to establish the (cost) effectiveness of
transmural collaborative care including a Consultation Letter for the GP and
duloxetine (TCCCL) versus Duloxetine in patients with depression that present
themselves with (sub)chronic pain. Therefore, in this proposed pragmatic trial,
such a module for treatment of concomitant (sub)chronic pain and depression
will be evaluated in terms of (cost)effectiveness in a design with three
treatment arms. The following three treatment options will be compared in a
factorial design: TCCCL + duloxetine versus TCCCL + placebo versus duloxetine.
Study design
Randomized Placebo-controlled for the medication part double blinded
multicenter trial. The following three treatment options will be compared in a
factorial design: TCCCL + duloxetine versus TCCCL + placebo versus duloxetine.
Intention to treat analysis will be performed.
Lead-in period: none. Design controls: double blind for medication part.
Intervention
The intervention will consist of TCCCL and/or Duloxetine.
Study burden and risks
During this study there are no risks for the patients and the patients will
only derive benefit from treatment.
Lage Witsiebaan 4
Tilburg 5000 AT
NL
Lage Witsiebaan 4
Tilburg 5000 AT
NL
Listed location countries
Age
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
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,
*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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-010188-18-NL |
| CCMO | NL30081.029.10 |