Effectiveness of the treatment of depressive disorder and comorbid pain symptoms

• Conditions: Major depressive disorder (episode or recurrent), as principal DSM-IV diagnosis combined with (sub)chronic pain symptoms as defined bij score of >3 on BPI painlist for at least six weeks.; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2009-010188-18-NL
• Lead Sponsor: Eli Lilly Nederland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-17
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

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

Inclusion Criteria

All the patients that are referred to the participating mental health centers are screened for depressive symptoms and pain complaints. Pain that has lasted 2 weeks or longer than expected is considered problematic and qualifies for treatment. This study will focus on patients with a depressive disorder and (sub)chronic pain complaints. Sub chronic pain is defined as pain of = 6 weeks [je noemt eerder 2 weken – kan verwarrend zijn] and chronic pain is defined as pain with a duration of at least 12 weeks. Consecutive patients that present themselves at the special mental health outpatient clinic will be screened for MDD and concomitant pain of = 6 weeks duration with a questionnaire.
This questionnaire will consist of the Patient Health Questionnaire depression sub-scale (PHQ-9) and the item on 'average pain' from the Brief Pain Inventory (BPI), that will be used as a screener for respectively depressive disorder and (sub)chronic pain symptoms. Also, the patient will receive an informed consent form with information about the study. Patients are eligible for the study if they have a score of 10 or more on the PHQ-9 and a score of 3 or more on the 'average pain' item of the BPI. When a patient screens positive on the questionnaires mentioned above, the patient will receive a telephonic interview in which a MINI interview will be administered in order to clinically confirm the diagnosis MDD and to confirm that the patient suffers from (sub)chronic pain. In that case, he or she will receive additional information about the treatment part of the study and will be asked if he or she is willing to participate. When the patient is willing to participate, the patient is included in the study. A baseline questionnaire with second informed consent form, for the treatment part of the study, will be sent to the patient’s home address or made available on a secured website
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 219
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 219

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.

Study & Design

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