Open-label, Multicenter Clinical Study of Dose-dependent Efficacy and Safety of Trazodone Hydrochloride in Patients wirh Major Depressive Disorder ans Pain (TIPAD Study) - TIPAD

• Conditions: Major Depression Disorder associated with painful physical symptoms; MedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depression

• Registration Number: EUCTR2007-002140-24-AT
• Lead Sponsor: CSC Pharmaceuticals Handels GmbH.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Subject diagnosed Major Depression associated with painful physical symptoms, and fulfilling the following criteria:

Concerning Painful physical symptoms:
at least 1 month prior to study start presence of PPS. Global Pain m assessed by the patient must correspond to = 60 mm VAS at Visit 2.

Concerning Major Depression:
at least 1 month prior to study start diagnosis of Major Depression according to DSM-IV criteria
Score 18 – 24 on the Hamilton Depression Rating Scale at Visit 2.
Male or female outpatients aged 18-65 years

If female of childbearing potential:
must have negative (urine) pregnancy test at screnning visit and at Visit 5.
Subject who, in the opinion of the investigator, would understand the meaning of the information sheet, would be co-operative and sufficiently reliable to use the medication as instructed, complete the diary and return for follow-up visits.
Subject has provided written informed consent prior to undergoing any study procedure.

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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will be excluded from the study for any of the following reasons:
Who is pregnant or breast-feeding.
Who has a known hypersensitivity to trazodone,
Who is suffering from known liver, kidney, cardiovascular, pulmonary or hematological disease
Who is suffering from asthma.
Who is suffering from cardiac malfunction
Who is suffering from epilepsy
Who is suffering from hypotension i.e. systolic blood pressure < 100 mm Hg
Who is suffering from hypertension i.e. diastolic > 90 mm HG or systolic > 140 mm HG
Who is suffering from bradycardia with a frequency < 45
Who has suffered from an ulcer, gastrointestinal bleeding and/or perforation within 2 years prior to the trial.
With evidence or history of drug or alcohol abuse.
Who has previously participated in this clinical study or any other clinical study in the past 30 days
With mental impairment limiting the ability to comply with study requirements
Who, in the opinion of the investigator, is unable or unwilling to complete the study

Study & Design

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