Cytokines and Inflammatory Marker during Therapy in Major Depression with Celecoxib - CITICOX

Clinic for Psychiatry and Psychotherapy of the Ludwig Maximilian University0 sites57 target enrollmentNovember 11, 2010

DrugsCelebrex

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Clinic for Psychiatry and Psychotherapy of the Ludwig Maximilian University
Enrollment: 57
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 11, 2010

End Date

October 18, 2013

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Clinic for Psychiatry and Psychotherapy of the Ludwig Maximilian University

Eligibility Criteria

Inclusion Criteria

•1\) Major depression diagnosed by psychiatrist
•2\) DSM IV TR: 296\.2x single depressive episode or 296\.3x recurrent depressive episode
•3\) HamD\-17 score \= 22
•4\) Informed consent
•5\) Age between 18 and 60 years
•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) no

Exclusion Criteria

•1\) Psychotic depression or bipolar disorder, drug or alcohol addiction, schizoaffective disorders, schizophrenia. Other disorders (e.g. obsessive compulsive disorder, anxiety disorder, personality disorder) in case the symptoms predominate the clinical picture.
•2\) Unsuccessful treatment with more than 2 antidepressant medications (at therapeutically adequate doses and duration) during current episode.
•3\) Concomitant use of psychotropic drugs, including mood stabilizers, besides defined co\-medication.
•4\) Immediate risk for suicidal behavior (3 on HamD\-17 rating scale or 5 on MAD Rating Scale).
•5\) Women who are pregnant, breast feeding or planning to become pregnant during the course of study.
•6\) Women who are not post\-menopausal (no natural menopause established in retrospect after 12 consecutive months of amenorrhea without hormone replacement therapy during the last 5 months), surgically sterilized or using a highly effective method of contraception (an implanted or injected hormonal contraceptive, some intrauterine contraceptive devices (IUDs) containing hormones, sexual abstinence, or have a vasectomized partner). Females using combined oral contraceptives should use a different or additional highly effective method of contraception as listed above.
•7\) Any history of cardiovascular disease (e.g. angina, heart attack, stroke, congestive heart failure), uncontrolled high blood pressure, documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, a history of peripheral arterial embolism or cerebrovascular disease.
•8\) Patients at risk of QT/QTc interval prolongation (QTc\> 450 ms, family history of long QT syndrome or use of medication prolonging QT/QTc interval).
•9\) History of coronary heart disease (CHD) or any other heart disease.
•10\) Serum NTproBNP \= 125 pg/mL indicating (sub\-) clinical heart failure.