Comparing Problem Solving Treatment combined with duloxetine with Problem Solving Treatment alone for patients with major depressive disorder in primary care - Praten & Pillen 6

• Conditions: Major depressive disorder (episode or recurrent), moderately severe as principal DSM-IV diagnosis.; MedDRA version: 9.1Level: LLTClassification code 10012378Term: Depression

• Registration Number: EUCTR2008-005695-27-NL
• Lead Sponsor: Eli Lilly Nederland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified