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Drug Therapy to Treat Minor Depression

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ClinicalTrials.gov Identifier: NCT00048815
Recruitment Status : Completed
First Posted : November 13, 2002
Results First Posted : May 10, 2018
Last Update Posted : May 10, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Andrew A. Nierenberg, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Citalopram Drug: St. John's Wort Drug: Placebos Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacotherapy for Minor Depression
Study Start Date : February 2003
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: citalopram
Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
Drug: Citalopram
Established Selective Serotonin Reuptake Inhibitor antidepressant
Other Name: Celexa, Cipramil
Experimental: St. John's Wort
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
Natural extract from the St. John's Wort plant.
Other Name: Hypericum
Placebo Comparator: Placebo
Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
Drug: Placebos
Placebo pill



Primary Outcome Measures :
  1. Efficacy Assessed Using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C) [ Time Frame: Change from Baseline to Week 12 ]
    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.

  2. Number of Adverse Events (Physical Symptoms) Emerging or Worsening During 12 Weeks of Treatment [ Time Frame: Change from Baseline to Week 12 ]
    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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048815


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
University of Pittsburgh, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: Andrew A. Nierenberg, M.D. Massachusetts General Hospital

Additional Information:
Responsible Party: Andrew A. Nierenberg, MD, Director Bipolar Clinic and Research Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00048815     History of Changes
Obsolete Identifiers: NCT00043524, NCT00050544
Other Study ID Numbers: R01MH061758 ( U.S. NIH Grant/Contract )
R01MH061758 ( U.S. NIH Grant/Contract )
R01MH061757 ( U.S. NIH Grant/Contract )
R01MH061394 ( U.S. NIH Grant/Contract )
DSIR AT-SO
First Posted: November 13, 2002    Key Record Dates
Results First Posted: May 10, 2018
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by Andrew A. Nierenberg, MD, Massachusetts General Hospital:
Minor Depression
St. John's Wart

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents