Drug Therapy to Treat Minor Depression

NCT00048815 | Completed Results DMC

• 4 other identifiers: R01MH061758R01MH061757R01MH061394DSIR AT-SO
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Depression

Keywords

Minor Depression; St. John's Wart

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

citalopram

ACTIVE COMPARATOR

Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.

Drug: Citalopram

St. John's Wort

EXPERIMENTAL

Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.

Drug: St. John's Wort

Placebo

PLACEBO COMPARATOR

Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.

Drug: Placebos

Interventions

Citalopram DRUG

Established Selective Serotonin Reuptake Inhibitor antidepressant

Also known as: Celexa, Cipramil

citalopram

St. John's Wort DRUG

Natural extract from the St. John's Wort plant.

Also known as: Hypericum

St. John's Wort

Placebos DRUG

Placebo pill

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Office of Dietary Supplements (ODS): collaborator

Study Sites (3)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Pittsburgh, Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

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

MeSH Terms

Conditions

Depression

Interventions

Citalopram; Dexetimide; Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Stringent inclusion criteria may have yielded a sample who depression was too mild to show added benefit for either active treatment beyond general therapeutic effects of study participation

Results Point of Contact

• Title: Mark Hyman Rapaport, M.D.
• Organization: Cedars Sinai Medical Center

mark.rapaport@cshs.org

310-423-2600

Study Officials

• Andrew A. Nierenberg, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Bipolar Clinic and Research Program

Study Record Dates

• First Submitted: November 8, 2002
• First Posted: November 13, 2002
• Study Start: February 1, 2003
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: May 11, 2018
• Results First Posted: May 11, 2018

Record last verified: 2018-05

Locations

US (3)