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Trial record 18 of 1054 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

Optimizing the Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) in Treatment-Resistant Depression

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ClinicalTrials.gov Identifier: NCT00093847
Recruitment Status : Completed
First Posted : October 8, 2004
Results First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
George I. Papakostas, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: S-adenosyl methione (SAMe)
Drug: Placebo
Enrollment 73
Recruitment Details 73 outpatients with major depressive disorder who were partial- or non-responders to SSRI/SNRI therapy were enrolled in this trial conducted at Massachusetts General Hospital.
Pre-assignment Details This was a randomzized (1:1) double-blind, placebo-controlled adjunct study of oral SAMe tosylate (target doses of 800mg PO BiD) to standard SSRI and SNRI antidepressants for patients with MDD.
Arm/Group Title Adjunct Oral SAMe Tosylate 800mg PO BiD Oral Adjunct Placebo
Hide Arm/Group Description Participants receiving the oral SAMe tosylate Participants receiving placebo
Period Title: Overall Study
Started 39 34
Completed 31 24
Not Completed 8 10
Arm/Group Title Adjunct Oral SAMe Tosylate 800mg PO BiD Oral Adjunct Placebo Total
Hide Arm/Group Description Participants receiving the oral SAMe tosylate Participants receiving placebo Total of all reporting groups
Overall Number of Baseline Participants 39 34 73
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 34 participants 73 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
  84.6%
32
  94.1%
65
  89.0%
>=65 years
6
  15.4%
2
   5.9%
8
  11.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 34 participants 73 participants
51.4  (14.1) 48.5  (11.3) 50.0  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 34 participants 73 participants
Female
21
  53.8%
23
  67.6%
44
  60.3%
Male
18
  46.2%
11
  32.4%
29
  39.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 34 participants 73 participants
39 34 73
1.Primary Outcome
Title Hamilton Depression Rating Scale Remission Rates
Hide Description The proportion of remitters for SAMe versus placebo was 46.1% versus 17.6%. Remission is defined as a final score of 7 or less on Hamilton Depression Rating Scale 17 item .
Time Frame Measured at Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT LOCF
Arm/Group Title Adjunct Oral SAMe Tosylate 800mg PO BiD Oral Adjunct Placebo
Hide Arm/Group Description:
Participants receiving the oral SAMe tosylate
Participants receiving placebo
Overall Number of Participants Analyzed 39 34
Measure Type: Number
Unit of Measure: Percentage of Remitters HDRS17
46.1 17.6
2.Secondary Outcome
Title HDRS17 Responders
Hide Description 35.8% versus 11.7%. Response is defined as a 50 percent or more score reduction on on Hamilton Depression Rating Scale 17 item .
Time Frame Measured at Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT LOCF
Arm/Group Title Adjunct Oral SAMe Tosylate 800mg PO BiD Oral Adjunct Placebo
Hide Arm/Group Description:
Participants receiving the oral SAMe tosylate
Participants receiving placebo
Overall Number of Participants Analyzed 39 34
Measure Type: Number
Unit of Measure: Percentage of Responders HDRS17
35.8 11.7
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adjunct Oral SAMe Tosylate 800mg PO BiD Oral Adjunct Placebo
Hide Arm/Group Description Participants receiving the oral SAMe tosylate Participants receiving placebo
All-Cause Mortality
Adjunct Oral SAMe Tosylate 800mg PO BiD Oral Adjunct Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adjunct Oral SAMe Tosylate 800mg PO BiD Oral Adjunct Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      0/34 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Adjunct Oral SAMe Tosylate 800mg PO BiD Oral Adjunct Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/39 (51.28%)      19/34 (55.88%)    
Gastrointestinal disorders     
Diarrhea *  7/39 (17.95%)  7 5/34 (14.71%)  5
Upper gastrointestinal upset *  14/39 (35.90%)  14 7/34 (20.59%)  7
Nervous system disorders     
Insomnia *  4/39 (10.26%)  4 2/34 (5.88%)  2
Somnolence and fatigue *  4/39 (10.26%)  4 2/34 (5.88%)  2
Headache *  4/39 (10.26%)  4 2/34 (5.88%)  2
Activation *  3/39 (7.69%)  3 4/34 (11.76%)  4
Vivid dreams *  0/39 (0.00%)  0 2/34 (5.88%)  2
*
Indicates events were collected by non-systematic assessment
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: Dr George Papakostas, M.D.
Organization: Massachusetts General Hospital
Phone: 6177266697
Responsible Party: George I. Papakostas, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00093847     History of Changes
Other Study ID Numbers: K23MH069629 ( U.S. NIH Grant/Contract )
K23MH069629 ( U.S. NIH Grant/Contract )
First Submitted: October 6, 2004
First Posted: October 8, 2004
Results First Submitted: April 25, 2012
Results First Posted: October 13, 2014
Last Update Posted: October 13, 2014