N/A
N=73
Drug Therapy to Treat Minor Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00048815 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Efficacy Assessed Using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C) — -11.47; -9.35; -10.49 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Citalopram (Drug); St. John's Wort (Drug); Placebos (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Assessed Using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C) |
-11.47; -9.35; -10.49 | — |
| PRIMARY Number of Adverse Events (Physical Symptoms) Emerging or Worsening During 12 Weeks of Treatment |
4.7; 5.0; 3.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00048815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.