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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Citalopram
Drug: St. John's Wort
Drug: Placebos

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Citalopram Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
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.
Placebo Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.

Participant Flow:   Overall Study
    Citalopram   St. John's Wort   Placebo
STARTED   24   26   23 
COMPLETED   18   22   19 
NOT COMPLETED   6   4   4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Citalopram Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
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.
Placebo Subjects in this arm received double-dummy (look-alike) placebo for 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Citalopram   St. John's Wort   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   26   23   73 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.3  (12.5)   42.2  (14.1)   51.4  (16.6)   48.1  (15.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      13  54.2%      13  50.0%      11  47.8%      37  50.7% 
Male      11  45.8%      13  50.0%      12  52.2%      36  49.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      2   8.3%      0   0.0%      1   4.3%      3   4.1% 
Not Hispanic or Latino      22  91.7%      26 100.0%      22  95.7%      70  95.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   24   26   23   73 


  Outcome Measures

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mark Hyman Rapaport, M.D.
Organization: Cedars Sinai Medical Center
phone: 310-423-2600
e-mail: mark.rapaport@cshs.org



Responsible Party: Andrew A. Nierenberg, MD, 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 Submitted: November 8, 2002
First Posted: November 13, 2002
Results First Submitted: June 17, 2014
Results First Posted: May 10, 2018
Last Update Posted: May 10, 2018