Pain, anxiety and depression in neuropathic and non-neuropathic pain: Effect of monoamine modulation.

• Conditions: Chronic pain: neuropathic pain and fibromyalgia; MedDRA version: 8.1Level: LLTClassification code 10033371Term: Pain

• Registration Number: EUCTR2006-005506-32-DK
• Lead Sponsor: Danish Pain Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1. Patients 18-75 years of age.

2. Patients with neuropathic pain. Diagnoses: peripheral nerve lesion, polyneuropathy in feet, spinal root compression, and post-herpetic neuralgia.

3. Patients with non-neuropathic pain. Diagnosis: fibromyalgia.

4. Daily pain present > 6 months.

5. Mean weekly pain score > 4 on an 11-point Likert scale the last week of the screening period.

6. Treatment with antidepressants (TCA, SSRI, SNRI, MAOI or others), gabapentin, pregabalin, and carbamazepine must be stopped at least two weeks before treatment phase.

7. Efficient contraception (women in the fertile age).

8. Written and verbal informed consent and letter of authority.

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Before the beginning of the study
1. Hypersensitivity to the active substance or to any of the excipients in duloxetine.

2. Severe renal impairment (creatinine clearance<30 ml/min.)

3. Liver disease resulting in hepatic impairment.

4. Comcomitant use of nonselective, irreversible or selective, reversible Monoamine Oxidase Inhibitors (MAOIs) within at least 14 days of discontinuing treatment with MAOI. Based on the half-life of duloxetine, at least 5 days should be allowed after stopping duloxetine before starting an MAOI.

5. Comcomitant use of fluvoxamine, ciprofloxacin or enoxacine (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine.

6. Comcomitant use of serotonergic medicinal products: SSRI´s, TCA´s like clomipramine or amitriptyline, john´s wort (hypericum perforatum), SNRI like venlafaxine or triptans, tramadol, pethidine and tryptofan (risk of serotonine syndrome).

7. Comcomitant use of anticoagulants, medical products known to affect platelet function, diuretic medication, alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines), flecainide, propafenone and metoprolol (risk of interaction).

8. Serious or unstable medical illness (e.g. apoplexy, Alzheimer’s disease, affected platelet function, dehydration, epilepsy, hypertension, haemodialysis, hyponatremia, fructose intolerance, glucose-galactose malabsorption, haemophilia, increased intraocular pressure, ischemic pain, uncontrolled narrow-angle glaucoma, Raynaud´s phenomenon, sucrose-isomaltase insufficiency, and previous case of anaphylactic shock reaction). Confirmed by medical history and, if possible, compared to medical records.

9. Current and previous diagnosis of mania, bipolar disorder, psychosis, severe agitation, imminent deliria, suicidal ideation, suicidal behaviour, alcohol or drug dependence (ICD-10). Confirmed by psychiatrical history and, if possible, compared to psychiatrical or medical records.

10. Prior participation in a duloxetine study.

11. Pregnancy and lactation.

After the beginning of the study (discontinuation)

1. Development of serious adverse effects or hypersensitivity to the active substance or to any of the excipients in duloxetine.

2. Hamilton Depression score > 18 or Major Depression Inventory > 39.9. (Antidepressant medication will be initiated immediately).

3. Suicidal ideation and suicidal behaviours (treatment will be initiated immediately).

4. Pregnancy.

5. Lack of compliance with regard to intake of study medication and diary records.

6. Intake of pain and/or antidepressant medication not included in the study.

7. The patient cannot co-operate during the examination.

8. The patient wishes to leave the study.

Study & Design

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