Drug Therapy to Treat Minor Depression

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital; National Institute of Mental Health (NIMH)
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Institute of Mental Health (NIMH); Office of Dietary Supplements (ODS)
• Treatments: Citalopram

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