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Phenotype Depression Study
Bu çalışma, majör depresyon veya bipolar bozukluğa bağlı depresyon (depression) yaşayan bireylerin biyolojik ve klinik özelliklerini (fenotip) incelemiştir. Çalışmaya 21-65 yaş arası, belirli depresyon ölçek puanlarını karşılayan bireyler alınmıştır. Faz uygulanmayan bir araştırma olarak yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * age 21-65 years including males, females and minorities * diagnosis of DSM-IV major depression or Bipolar I or II with current episode of depression * HDRS-17 \> 20 and HDRS-24 \> 24 * negative pregnancy test for women of childbearing potential * not breast feeding * stable on current dose of psychotropic medication or free from all psychotropic medications for 4 weeks prior to EUH CIN admission (8 weeks for fluoxetine) * no suicide attempt within six months of screening Exclusion Criteria: * evidence of untreated or poorly controlled endocrine, cardiovascular, pulmonary, hematological, renal, or neurological disease * history of CNS trauma or active seizure disorder requiring medication unless otherwise approved by principle investigator * autoimmune or inflammatory disorder of any kind * chronic infection (e.g. hepatitis B or C or HIV) * chronic use of agents known to affect the immune system including glucocorticoid therapy within the past 1 year, methotrexate within the past 1 year, chemotherapy of any kind (past or present), immunotherapy of any kind (past or present), aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) (within the past 2 weeks) and statins (within the past 1 month) unless otherwise approved by principle investigator * hemoglobinopathies (e.g. thalassemia) * a positive pregnancy test * organ transplants * cancer of any type * a score of \<28 on the Mini Mental Status Exam (MMSE)unless otherwise approved by principle investigator * meets criteria for schizophrenia (Given overlap of generalized anxiety disorder (GAD) with major depression, GAD will not be exclusionary) * current eating disorders * active abuse of alcohol or illicit/prescription drugs within the past year unless otherwise approved by principle investigator. * MGH-S \>3 unless otherwise approved by principle investigator * BMI \>40 unless otherwise approved by the principle investigator * active suicidal intent or plan and a score \>2 on the HDRS suicide item (item #3). * any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol