Drug Therapy to Treat Minor Depression

Completed · Not applicable · Has a placebo group

Conditions studied: Depression

In brief

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

Key facts

Study ID

NCT00048815

Run by

Massachusetts General Hospital

People needed

73

Starts

2003-02-01

Expected to finish

2007-04-01

Last updated by the study team

2018-05-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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