p11 Protein Levels in Patients With Major Depressive Disorder Treated With Citalopram

Completed

Conditions studied: Depression

In brief

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. ...

Key facts

Study ID

NCT00697268

Run by

National Institute of Mental Health (NIMH)

People needed

38

Starts

2008-06-03

Expected to finish

2016-07-28

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• CRITERIA FOR EXCLUSION OF DEPRESSED PATIENTS:
• history of bipolar disorder (I, II, or NOS) (lifetime)
• history of schizophrenia
• history of schizoaffective disorder or
• psychosis NOS (lifetime)
• history of anorexia nervosa or bulimia nervosa (lifetime)
• current primary obsessive-compulsive disorder (OCD) or current post traumatic stress disorder (PTSD) whose onset preceded the onset of Major Depressive Disorder
• history of clear-cut intolerability to the study medication
• lack of response to an adequate trial of the study medication (citalopram) in the current or past episodes of MDD
• did not respond to 7 or more sessions of ECT in the current episode of MDD
• Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
• has general medical condition which contraindicates the use of the study medication
• is on concomitant medication which contraindicates the use of the study medication
• requires immediate hospitalization for psychiatric disorder
• requires antipsychotic medications or mood stabilizers
• Non-postmenopausal (less than 2 years since last period) females of childbearing potential who are sexually active and who are not using adequate (hormonal, double barrier, surgical) contraception, or who are pregnant or breast feeding
• patients currently taking any of the exclusionary medications detailed in protocol (including antipsychotic medications, anticonvulsant medications, antidepressant medications, mood stabilizers, central nervous system stimulants) in the 2 weeks prior to Study Period II.
• patients taking thyroid medication for hypothyroidism may be included if they have been stable on the medication for greater than 3 months
• patients can participate in a modality of psychotherapy that is not targeting the symptoms of depression (e.g., supportive therapy, marital therapy)
• therapy that is depression specific, such as Cognitive Therapy (CT) or Interpersonal Psychotherapy of Depression (IPT) is not allowed during participation
• subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent.
• current alcohol dependence or abuse (last 3 months)
• patient has a prolonged QTc (greater than or equal to 450 msec), as shown on ECG
• Current NIMH employee/staff or their immediate family member.
• ADDITIONAL CRITERIA FOR EXCLUSION OF DEPRESSED PATIENTS FOR MRI IMAGING:

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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