|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
19 March 2012 |
|
Main ID: |
EUCTR2008-005695-27-NL |
|
Date of registration:
|
16/09/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Comparing Problem Solving Treatment combined with duloxetine with Problem Solving Treatment alone for patients with major depressive disorder in primary care - Praten & Pillen 6
|
|
Scientific title:
|
Comparing Problem Solving Treatment combined with duloxetine with Problem Solving Treatment alone for patients with major depressive disorder in primary care - Praten & Pillen 6 |
|
Date of first enrolment:
|
02/12/2008 |
|
Target sample size:
|
|
|
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005695-27 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: problem solving treatment (PST) WITHOUT pharmacotherpeutic addition
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
PHQ-9 > 9 (first screening)
actual screening
Principal DSM-IV diagnosis: major depressive disorder (episode or recurrent), moderately severe.
IDS-SR30 score > 22
Age 18-65
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Too ill, according to GP’s judgement immediate start treatment or transfer to outpatient department is necessary.
Indication for immediate crisis intervention or hospital admittance due to e.g severe suicidal risk, serious suicidality or severe psychotic symptoms
Medical contraindications for duloxetine
Use of antipsychotic medication or mood stabilizers
Drug abuse or dependence in the past six months
Current use of any hard drug or cannabis (more than 3 units a week)
More than 4 units of alcohol per day
Pharmacological drugs that influence psychic functions
Pregnancy and breast feeding
Use of St John's worth (hypericum perforatum)
Inability to participate in case of to severe language barrier
Patient follows psychotherapy
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Major depressive disorder (episode or recurrent), moderately severe as principal DSM-IV diagnosis.
MedDRA version: 9.1
Level: LLT
Classification code 10012378
Term: Depression
|
|
Intervention(s)
|
Trade Name: Cymbalta
Product Name: duloxetine
Product Code: Cymbalta
Pharmaceutical Form: Capsule, hard
|
|
Primary Outcome(s)
|
Secondary Objective: 1. are there intervening variables such as somatic symptoms that interact with the treatment condition?
2. temporal relationship between the reduction of depressive symptoms and somatic symptoms.
3. does providing a structured way of assisting patients with their difficulties by PST will enhance adherence to pharmacotherapy (see protocol)
4. does PST will enhance of the sense of mastery and coping in MDD patients ?
5. do other characteristics, such as demographic variables, depression characteristics (severity and duration) and co morbidity predict a different outcome for either treatment condition.
6. what are the effects of the interventions on symptom reduction rates and the quality of life 12 months after the beginning of the treatment.
|
|
Primary end point(s): 50% reduction at IDS-SR30 score from baseline to study periods’ endpoint
|
|
Main Objective: The primary objective is assessing the depressive symptom reduction rate of mono-treatment (PST) compared to combined treatment (PST and duloxetine) in patients with major depressive disorder. In other words, testing the hypothesis that combined treatment is more effective than mono-treatment in patients with major depressive disorder.
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|