Majör Depresif Bozukluk – Beyin ve Kalp Arasındaki Bağlantıyı Anlamak

Sade dilde özet

Bu çalışma, majör depresif bozukluk (major depressive disorder) tedavisinde onaylı bir seçici serotonin geri alım inhibitörü (selective serotonin re-uptake inhibitor, SSRI) antidepresanın etkilerini ve beyin ile kalp arasındaki ilişkiyi incelemektedir. Çalışmaya 18-70 yaş arası, depresyon tanısı olan ve halihazırda antidepresan kullanmayan kişiler alınmıştır. 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

Baker Heart and Diabetes Institute

Müdahale

Participants will be prescribed an approved selective serotonin re-uptake inhibitor (SSRI) antidepressant.

Başlangıç

01.05.2012

Tahmini bitiş

01.12.2020

Ülkeler

Australia

İlgili genler

Merkezler

• Ballarat, Australia
• Clayton, Australia
• Melbourne, Australia
• Melbourne, Australia

Uygunluk kriterleri

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

Inclusion Criteria:

* Aged 18-70 years.
* Capable of understanding and willing to provide signed and dated written, voluntary informed consent in advance of any protocol-specific procedures.
* MDD or MDD with melancholia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria. Patients with comorbid panic or anxiety disorders will be included if MDD is the primary diagnosis.
* Hamilton Depression (HAM D) \> 18.
* Beck Depression Inventory (BDI-II) \> 18.

Exclusion Criteria:

* Aged \< 18 or \> 70 years.
* Current antidepressant treatment.
* Previous failed response to SSRI treatment at the maximum tolerated dose for at least 4 weeks.
* Known or suspected hypersensitivity to the prescribed antidepressant or any of its ingredients.
* Current high suicide risk.
* Comorbid panic or anxiety disorders as the primary diagnosis.
* Pre-existing and/or current diagnosed heart disease.
* Comorbid medical conditions including type 1 diabetes, medicated hypertension, epilepsy, bleeding disorders, alcohol/drug dependence, infectious blood diseases, psychotic disorders, personality disorders, eating disorders, mental retardation, dementia (ie, Mini Mental State Examination \[MMSE\] \< 23), or gastrointestinal illness or previous bariatric (weight loss) surgery that may impair antidepressant absorption.
* Clinically significant abnormalities on examination or laboratory testing and clinically significant medical conditions not listed above that are serious and/or unstable.
* Pregnant or breastfeeding women.
* Women of childbearing potential (WOCP) who are not using medically accepted contraception (ie, intrauterine devices \[IUDs\], hormonal contraceptives \[oral, depot, patch or injectable\], and double barrier methods such as condoms or diaphragms with spermicidal gel or foam). Women who are postmenopausal (amenorrhea for at least 12 consecutive months) or surgically sterile are not considered to be WOCP.