At a glance
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An Investigation to Determine Whether Levels of P11 Protein in Peripheral Blood Cells Correlate With Treatment Response to Citalopram in Patients With Major Depressive Disorder
In Brief
An observational study for Depression. Completed, enrolled 38 participants across 1 site.
Detailed Summary
This study will compare levels of p11 protein in people with and without major depressive disorder (MDD) and examine if p11 levels in patients are affected by treatment with citalopram (Celexa). Healthy normal volunteers and patients with chronic or recurrent major depression between 18 and 65 years of age may be eligible for this study. Participants undergo the following tests and procedures: Healthy Volunteers * Psychiatric interview and medical examination, questions about family history * Blood draw Patients with MDD Phase 1 - Evaluation and Discontinuation of Medications * Physical examination, electrocardiogram, blood tests * Gradual antidepressant medication withdrawal, followed by 2- to 6-week drug-free period. If needed, medicines for anxiety and difficulty sleeping may be prescribed. Phase 2 Citalopram Treatment * Start daily citalopram treatment * Evaluations at the start of phase 2 and every week for 8 weeks with following procedures: * Symptoms ratings interview and questionnaires * Review of side effects and new medications * Blood pressure and pulse measurements * Blood and urine tests At the end of the study, plans are developed for long-term treatment and transfer of care to the patient s own physician. ...