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

NCT00697268 | Completed

• 2 other identifiers: 08015008-M-0150
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. ...

Conditions

Depression

Keywords

Depression; Depression Treatment; Unipolar Depression; Citalopram; Serotonin; Major Depression; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• We will study whether blood cell levels of p11 differ between healthy individuals and patients with depression. Moreover, we will study whether the levels of p11 are affected by treatment with the selective serotonin reuptake inhibitor, citalopr...

  Baseline, +1 week, +2 weeks, +3 weeks, +4 weeks, +5 weeks, +6 weeks, +7 weeks, +8 weeks

Secondary Outcomes (1)

• Complementary work will continue at other laboratories to better characterize the role of p11 in the pathophysiology of depression (e.g., animal studies, post-mortem studies).

  Baseline, +1 week, +2 weeks, +8 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65 years
• written informed consent completed (consent-incapacitated subjects will not be eligible)
• score 20 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS)
• meets DSM-IV criteria for chronic or recurrent nonpsychotic MDD
• patients who are on non-excluded concomitant medications.
• no more than 3 failed antidepressant treatments within the current major depressive episode
• no alcohol use (last 7 days)
• age 18 55 years
• subjects must have either a family history of mood disorders, or have a history of
• multiple major depressive episodes
• age of onset of depressive symptoms less than 45 years
• no history of past alcohol or substance dependence (excluding nicotine) or alcohol or substance abuse (excluding nicotine) within the past year.
• no use of benzodiazepines within 2 weeks of either MRI scan
• age 18-65 years
• written informed consent completed

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Barnes NM, Sharp T. A review of central 5-HT receptors and their function. Neuropharmacology. 1999 Aug;38(8):1083-152. doi: 10.1016/s0028-3908(99)00010-6.

  PMID: 10462127 BACKGROUND

• Greenberg PE, Kessler RC, Birnbaum HG, Leong SA, Lowe SW, Berglund PA, Corey-Lisle PK. The economic burden of depression in the United States: how did it change between 1990 and 2000? J Clin Psychiatry. 2003 Dec;64(12):1465-75. doi: 10.4088/jcp.v64n1211.

  PMID: 14728109 BACKGROUND

• Katon W, Von Korff M, Lin E, Walker E, Simon GE, Bush T, Robinson P, Russo J. Collaborative management to achieve treatment guidelines. Impact on depression in primary care. JAMA. 1995 Apr 5;273(13):1026-31.

  PMID: 7897786 BACKGROUND

MeSH Terms

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Study Officials

• Carlos A Zarate, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 13, 2008
• Study Start: June 3, 2008
• Study Completion: July 28, 2016
• Last Updated: December 17, 2019

Record last verified: 2016-07-28

Locations

US (1)