Drug Therapy to Treat Minor Depression

Depression Clinical Trial

Official title:

Pharmacotherapy for Minor Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048815
• Other study ID #: R01MH061758
• Secondary ID: R01MH061758R01MH
• Status: Completed
• Phase: N/A
• Start date: February 2003
• Est. completion date: April 2007

Study information

• Verified date: May 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Subjects participated in a 12-week double-blind randomized study comparing St. John's Wort, citalopram, and placebo. Subjects were recruited through clinical referrals and community advertising. Data were obtained at the baseline visit (just prior to randomization) and at postrandomization visits conducted at 2-week intervals for the next 12 weeks, for a modified intent-to-treat sample consisting of all 73 subjects with at least 1 post-randomization visit (evaluable sample).

Other known NCT identifiers

• NCT00043524
• NCT00050544

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Citalopram
Established Selective Serotonin Reuptake Inhibitor antidepressant
• St. John's Wort
Natural extract from the St. John's Wort plant.
• Placebos
Placebo pill

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Center for Complementary and Integrative Health (NCCIH), National Institute of Mental Health (NIMH), Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Assessed Using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)	We expect that subjects with minor depression treated for 12 weeks with St. John's Wort or citalopram will have significantly greater reduction in depressive symptom severity than those treated with placebo. This will be measured by blind ratings on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C) which has a total score range from 0 to 84 with 0 being not depressed at all and 84 being the most depressed. The change will be calculated by subtracting the Week 12 score from the Baseline score.	Change from Baseline to Week 12
Primary	Number of Adverse Events (Physical Symptoms) Emerging or Worsening During 12 Weeks of Treatment	We expect that subjects treated for Minor Depression for 12 weeks with either St. John's Wort or citalopram will have similar safety profiles to subjects treated with placebo, and will not differ by more than 20% in rates of adverse side effects (e.g., nausea, headache, insomnia, hypersomnia, diarrhea) from subjects treated with placebo. This was measured by the number of adverse events (physical symptoms) emerging or worsening during 12 weeks of treatment.	Change from Baseline to Week 12

External Links

•   Click here to view the "Treatment for Minor Depression" NIH news release.