Duloxetine Kullanımı Sırasında fMRI ile Beynin Duygusal Görüntülere Verdiği Yanıtın İncelenmesi

Sade dilde özet

Bu çalışma, majör depresif bozukluk (major depressive disorder) yani majör depresyon tanısı olan kişilerde Duloxetine ilacı kullanılırken beynin duygusal görüntülere verdiği yanıtı fMRI beyin görüntüleme yöntemiyle incelemektedir. Çalışmaya, 18-60 yaş arası, depresyon tanı ölçütlerini karşılayan ve MRI çekimine uygun kişiler katılabilmiştir. Çalışma Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 4 (Phase 4)

Durum

Tamamlandı

Sponsor

Indiana University

Müdahale

Duloxetine

Başlangıç

01.09.2007

Tahmini bitiş

01.04.2009

Ülkeler

United States

İlgili genler

Merkezler

• Indianapolis, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria for Depressed Patients:

* Ages 18 - 60 years and able to give voluntary informed consent.
* Satisfy criteria for Major Depressive Disorder (MDD) and current depressed episode using the Structured Clinical Interview for DSM-IV (SCID-IV).
* 17-item Hamilton Depression Rating Scale (HDRS) score \> 18.
* Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire.
* Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following:

  * Symptoms not worsening by more than 10 points on the HDRS during the course of the study.
  * No danger to self or others.

Exclusion criteria for patients:

* Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar disorder, atypical psychosis, mental retardation, or organic mental (including organic mood) disorder.
* Known hypersensitivity to duloxetine or any of the inactive ingredients.
* On monoamine oxidase inhibitors in the past 2 weeks.
* History of narrow angle glaucoma
* Lack of response of the current episode of depression to two or more adequate courses of antidepressant therapy at a clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression.
* Use of neuroleptic in the past 2 weeks.
* Use of antidepressants in the past 2 weeks. If on fluoxetine in the past, then should not have been on this medication for 4 weeks.
* History of lack of response to duloxetine.
* Use of mood stabilizers in the past 2 weeks.
* Use of benzodiazepines in the past 2 weeks.
* Acutely suicidal or homicidal or requiring inpatient treatment.
* Meeting DSM-IV criteria for other substance dependence within the past year, except caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening initially and on test days.
* Use of alcohol in the past 1 week.
* No serious medical or neurological illness as assessed by physical examination and laboratory examination including CBC and blood chemistry.
* Current pregnancy or breast-feeding.
* Metallic implants.
* Previously known positive HIV blood test as reported by the subject.