We aim to achieve a study population of 30 patients (male or female, 18 to 65 years of age) suffering from major depressive disorder (DSM IV criteria). Depressive symptoms should be present for at least 3 weeks (Hamilton depression rating scale >17). Patients will be examined on admission and after 6 weeks of treatment with duloxetine. Only patients without any psychiatric medical treatment for 8 weeks will be considered. 30 controls matched with respect to age and sex will be included.
Conditions
Interventions
Trade Name: Cymbalta
Product Name: Duloxetine
Pharmaceutical Form: Capsule*
INN or Proposed INN: Duloxetine
CAS Number: 116539594
Current Sponsor code: Duloxetine
Other descriptive name: Antidepressan
Sponsors
Department of Psychiatry and Psychotherapy, Friedrich-Schiller-University Jena
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject inclusion criteria: All participants: • Ability to understand and transform the explanations and advices of the investigator. • Signature on a legally effective consent form Patients • Major depressive disorder (MDD) according to DSM IV criteria • Depressive symptomatology for at least 3 weeks (Hamilton depression rating scale, (HAM-D-21 >17)) • Male or female patients • 18 years to 65 years of age Annotation: Women of the patient group of child-bearing age will only be enclosed into the study after pregnancy has been excluded using specific pregnancy tests. Furthermore they have to have a sufficient contraception method with a scientifically proven low failure rate (Pearl-Index of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients exclusion criteria: • Age below 18 years or above 65 years • Pregnancy or lactation • Participation in another clinical trial in the previous 8 weeks • Patients scoring higher than ‘2’ on the present pain intensity scale (PPI; McGill Pain Questionnaire (Melzack, 1975)). • Serious and unstable medical illnesses (e.g. heart, liver or kidney disease) • Other psychiatric illnesses not allowed by the protocol, for example, schizophrenia, schizoaffective disorder, bipolar disorder, mania, anxiety disorder, eating disorders or personality disorders • Current substance abuse or dependence disorders • Patients with severe liver diseases (such as hepatitis, icterus), cave with comedication of liver damaging medications • Elevated serum liver enzymes (above 2-fold upper reference range) • Patients with severe renal disease (creatinine clearance 160 mmHg) • Known mydriasis, elevated intraocular pressure, predisposition to narrow angle glaucoma in the past or present medical history • Past or present medical history of epilepsy • Predisposition for bleedings • Therapy with anticoagulants (heparin, heparinoids, hirudin, cumarin derivates, Warfarin) and thrombocyte aggregation inhibitors (acetyl salicyl acid (ASS), clopidogrel, combination from ASS and dipyridamol (Aggrenox®), ticlopidin) • Hypersensitivity against duloxetine or other components of the duloxetine capsule, such as sucrose • Hereditary Fructose intolerance • Glucose-Galactose malabsorption • Sucrase-Isomaltase deficiency • Comedication with antipsychotic agents, opioids, phenobarbital, sedative histamine antagonists • Comedication with non-selective, irreversible MAO (monoaminooxidase) inhibitors, selective reversible MAO inhibitors, at present or in the last 14 days • Comedication with other antidepressants (especially SSRI´s, other SNRI´s, tricyclic antidepressants), St. John´s wort (Hpericum perforatum), venlafaxin, triptans, pethidin, tramadol, tryptophan, substances which are mainly metabolised over CYP2D6 (such as, risperidon, flecainid, propafenon, metoprolol), tolterodin • Comedication with potent CYPA2 inhibitors (such as fluvoxamin, ciprofloxacin, enoxacin) Control subjects exclusion criteria: • Age below 18 years or above 65 years • Participation in another clinical trial in the previous 8 weeks • Control subjects scoring higher than ‘2’ on the present pain intensity scale (PPI; McGill Pain Questionnaire (Melzack, 1975)). • Serious and unstable medical illnesses (e.g. heart, liver or kidney disease) • All psychiatric illnesses, e.g. affective disorders such as depression, bipolar disorder or anxiety disorder, schizophrenia, schizoaffective disorder, eating disorders, personality disorders • Current substance abuse or dependence disorders Lorazepam up to 3 mg/d is allowed, but needs to be discontinued 2 two days before pain assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that duloxetine normalizes increased electrical and thermal pain thresholds to control levels within 6 weeks of treatment and improves reaction to A-delta and C-fiber laser stimulation in depressed subjects similar to controls. ;Secondary Objective: To test the hypothesies that duloxetine prolongs the onset latency (in seconds) of ischemic pain in depressed patients up to levels of control patients within 6 weeks of treatment, indicating profound analgesic effects on deep somatic pain. ;Primary end point(s): Improvement of A-delta and C-fibre stimulation reaction in MDD. Significantly increased electrical and thermal pain thresholds / tolerances and decreased ischemic pain thresholds / tolerances after 6 weeks of duloxetine treatment in MDD patients. | — |
Countries
Germany
Outcome results
None listed