Status:
UNKNOWN
The Effect of Duloxetine on Interoceptive Awareness
Lead Sponsor:
University Hospital, Bonn
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Depressive Disorder
Eligibility:
All Genders
21-65 years
Brief Summary
This study focuses on possible mechanism mediating duloxetine effects on painful physical symptoms in patients suffering from MDD. Our hypothesis is based on the assump¬tion of dual impairment of the ...
Eligibility Criteria
Inclusion
- Male and female (female are enrolled only under the condition of proof of using a safe and medially accepted contraceptive. According to the "Note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals" (CPMP/ICH/286/95, modification) contraceptives with a pearl-index\<1% are considered safe and effective. Among these only hormonal contraceptives, micro-pill and tubal ligantions will be accepted in this study)
- Between the ages of 21 and 65 years; and
- A diagnosis of major depression (HDRS\>=15) and
- A minimum of 25 mm on a VAS measure of painful symptoms (ranging from 0-100 mm), but no need for regular pain medication and HAMD-17 item 13 minimum rated as 1,
- Medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories (CBC w/ differential, TSH, Free-T4, ASAT, ALAT, GGT, BUN, creatinine, calcium, phosphorous, magnesium, total protein, albumin, electrolytes) and
- Absence of substance abuse on the basis of history and urine toxicology at screening.
Exclusion
- DSM-IV psychiatric and substance abuse diagnosis (excluding nicotine dependence) by history or psychiatric evaluation that includes a structured diagnostic interview for non-patient populations (SCID-NP)
- Current suicide risk sufficient to preclude treatment on an outpatient base: Higher than "2" on the "suicide" item of HAMD-17, or history of suicide attempt(s) in the past 12 months, or who, in the investigator's judgment, poses a current suicidal or homicidal risk.
- Clinical indications of organic brain disease, dementia, or cognitive impairment.
- History of substance dependence other than nicotine and consumption within the last year
- Any medical condition that would preclude the use of duloxetine treatment as
- A known hypersensitivity to duloxetine or any of the inactive ingredients.
- Intake of monoamine oxidase inhibitors (MAOIs) or suffering from uncontrolled narrow-angle glaucoma.
- Signs of any hepatic insufficiency
- Intake of inhibitors of CYP1A2 (as fluvoxamine, ciprofloxacin, enoxacin)
- End-stage renal disease (requiring dialysis) or severe renal impairment (estimated creatinine clearance \[CrCl\] \<30 mL/min)
- Subnormal intellectual potential as assessed by the WST-IQ \[Metzler. und Schmidt, 1992\]
- Healthy controls will meet exclusion and inclusion criteria, but will have no current or prior diagnosis of major depression.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00337012
Start Date
July 1 2007
Last Update
December 1 2008
Active Locations (1)
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1
University Clinic Bonn
Bonn, North Rhine-Westphalia, Germany, 53105