Drug Therapy to Treat Minor Depression - Full Text View

Sponsors and Collaborators:	National Institute of Mental Health (NIMH) National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00048815

Purpose

This 6-month study will compare the effectiveness of citalopram (Celexa®), hypericum (St. John's Wort), and placebo for the treatment of minor depression.

Condition	Intervention
Depression	Drug: Citalopram Drug: St. John's Wort

MedlinePlus related topics: Depression

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Pharmacotherapy for Minor Depression

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:	300
Study Start Date:	February 2003

Detailed Description:

Minor depression is highly prevalent, causes substantial morbidity and disability, presents a serious risk factor for the development of major depressive disorder, yet is under recognized and under treated. Researchers have determined that patients with minor depression frequently seek treatment from general practitioners and are often treated with prescription antidepressants. There is a need to evaluate the effectiveness of St. John's Wort in the management of minor depression. If the proposed study demonstrates the efficacy of St. John's Wort and/or citalopram, it will suggest treatment paradigms that can be tested and applied in primary care settings.

Patients who meet screening criteria enter a 2-week washout period (or, for fluoxetine, a 4-week washout period) during which no psychotropic medication is permitted. Participants are then randomly assigned to St. John's Wort, citalopram, or placebo for 12 weeks. Participants who respond to treatment by Week 12 continue to take their originally assigned double-blind medication for up to 26 weeks. At Week 12, nonresponders to placebo are crossed over to 1 of the 2 active treatments. Patients who remain nonresponders to that active treatment are crossed over to the alternative active treatment, with the investigator maintaining blind status. Participants have study visits at screening, during the washout period, at baseline, and every 2 weeks thereafter for the course of the study. At the screening visit, Week 12, and Week 20, patients undergo a complete blood count with differential and other routine laboratory tests.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Minor Depression symptoms for at least 6 months
Endorse one of the DSM-IV "A" criteria for MDD and at least one other symptom of MDD or endorse both of the "A" criteria for MDD
Global Assessment of Functioning (GAF) score < 70
Short form health survey (SF-36) social functioning score <= 75% or an emotional role functioning score <= 67%
HAM-D-17 score 10-17, inclusive
Minor depression symptoms for at least 6 months

Exclusion Criteria:

Major depressive disorder (MDD) or dysthymia within the past year or in partial remission of MDD
At least a 12-week course of either citalopram at a minimum or 40 mg/day or St. John's Wort at a minimum of 900 mg/day during the current episode of depression
Previous intolerance to either citalopram or St. John's Wort or history of nonresponse to either citalopram at a minimum of 40 mg/day or St. John's Wort at a minimum of 900 mg/day for at least 12 weeks
Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease
Uncontrolled seizure disorder
The following DSM-IV diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last year or patients with a positive urine drug screen; schizophrenia; delusional disorder; psychotic disorders not elsewhere classified; bipolar disorder; bereavement; adjustment disorder; antisocial personality disorder; panic disorder, social phobia, generalized anxiety disorder (GAD), or obsessive compulsive disorder (OCD). Patients may have a lifetime diagnosis of an anxiety disorder as long as it is not current.
Mood-congruent or mood-incongruent psychotic features
Psychotropic drugs
Hypothyroidism
Investigational psychotropic drugs within the last year
Positive toxicology screen
Medications metabolized by the CYP3A4 system, where induction of this system poses a risk to the medical stability of the patient
Pregnancy or refusal to use a medically accepted method of contraception
Serious suicide or homicide risk
Psychotherapy beginning less than 3 months ago

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048815

Locations

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
University of Pittsburgh, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

National Center for Complementary and Alternative Medicine (NCCAM)

Office of Dietary Supplements (ODS)

Investigators

Principal Investigator:

Andrew A. Nierenberg

More Information

Click here to view the "Treatment for Minor Depression" NIH news release. This link exits the ClinicalTrials.gov site

Study ID Numbers:	R01 MH61758, R01 MH61757, R01 MH61394, DSIR AT-SO
Study First Received:	November 8, 2002
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00048815
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Dexetimide

Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 30, 2009