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Drug Therapy to Treat Minor Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Citalopram
St. John's Wort
Placebos
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Minor Depression, St. John's Wart

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Massachusetts General Hospital
  • University of Pittsburgh, Western Psychiatric Institute and Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

citalopram

St. John's Wort

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 8, 2002
Last Updated
May 9, 2018
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH), National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
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1. Study Identification

Unique Protocol Identification Number
NCT00048815
Brief Title
Drug Therapy to Treat Minor Depression
Official Title
Pharmacotherapy for Minor Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH), National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Minor Depression, St. John's Wart

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
citalopram
Arm Type
Active Comparator
Arm Description
Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
Arm Title
St. John's Wort
Arm Type
Experimental
Arm Description
Subjects in this arm received 810 mg/day of St. John's Wort taken orally (in three tablets of 270mg each) for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
Celexa, Cipramil
Intervention Description
Established Selective Serotonin Reuptake Inhibitor antidepressant
Intervention Type
Drug
Intervention Name(s)
St. John's Wort
Other Intervention Name(s)
Hypericum
Intervention Description
Natural extract from the St. John's Wort plant.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo pill
Primary Outcome Measure Information:
Title
Efficacy Assessed Using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C)
Description
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.
Time Frame
Change from Baseline to Week 12
Title
Number of Adverse Events (Physical Symptoms) Emerging or Worsening During 12 Weeks of Treatment
Description
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.
Time Frame
Change from Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew A. Nierenberg, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Pittsburgh, Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.nimh.nih.gov/science-news/2003/treatment-for-minor-depression.shtml
Description
Click here to view the "Treatment for Minor Depression" NIH news release.

Learn more about this trial

Drug Therapy to Treat Minor Depression

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