Protocol Number: 08-M-0150

Title:

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

Number:

08-M-0150

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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

CRITERIA FOR INCLUSION OF DEPRESSED PATIENTS:

-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)

CRITERIA FOR INCLUSION OF HEALTHY CONTROL SUBJECTS:

-age 18-65 years

-written informed consent completed

-no current or past diagnosis of axis I psychiatric disorder (DSM-IVTR)

-no alcohol use (last 7 days)

-physically healthy

EXCLUSION CRITERIA:

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)

-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)

CRITERIA FOR EXCLUSION OF HEALTHY CONTROL SUBJECTS:

-subjects currently taking any of the exclusionary medications detailed in protocol in the 2 weeks prior to evaluation

-current alcohol dependence or abuse (last 3 months)

-history of major depression or bipolar disorder in any first degree relative

Special Instructions:

Currently Not Provided

Keywords:

Depression

Depression Treatment

Unipolar Depression

Citalopram

Serotonin

Recruitment Keyword(s):

Major Depression

Healthy Volunteer

HV

Condition(s):

Depression

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Mental Health

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Barnes NM, Sharp T. A review of central 5-HT receptors and their function. Neuropharmacology. 1999 Aug;38(8):1083-152. Review.

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.

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.

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