Trial Outcomes & Findings for Optimizing the Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) in Treatment-Resistant Depression (NCT NCT00093847)

Results Overview

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 .

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

73 participants

Primary outcome timeframe

Measured at Week 6

Results posted on

2014-10-13

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Adjunct Oral SAMe Tosylate 800mg PO BiD Participants receiving the oral SAMe tosylate	Oral Adjunct Placebo Participants receiving placebo
Overall Study STARTED	39	34
Overall Study COMPLETED	31	24
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adjunct Oral SAMe Tosylate 800mg PO BiD n=39 Participants Participants receiving the oral SAMe tosylate	Oral Adjunct Placebo n=34 Participants Participants receiving placebo	Total n=73 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	32 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	51.4 years STANDARD_DEVIATION 14.1 • n=5 Participants	48.5 years STANDARD_DEVIATION 11.3 • n=7 Participants	50.0 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	11 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	34 participants n=7 Participants	73 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Week 6

Population: ITT LOCF

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 .

Outcome measures

Outcome measures
Measure	Adjunct Oral SAMe Tosylate 800mg PO BiD n=39 Participants Participants receiving the oral SAMe tosylate	Oral Adjunct Placebo n=34 Participants Participants receiving placebo
Hamilton Depression Rating Scale Remission Rates	46.1 Percentage of Remitters HDRS17	17.6 Percentage of Remitters HDRS17

SECONDARY outcome

Timeframe: Measured at Week 6

Population: ITT LOCF

35.8% versus 11.7%. Response is defined as a 50 percent or more score reduction on on Hamilton Depression Rating Scale 17 item .

Outcome measures

Outcome measures
Measure	Adjunct Oral SAMe Tosylate 800mg PO BiD n=39 Participants Participants receiving the oral SAMe tosylate	Oral Adjunct Placebo n=34 Participants Participants receiving placebo
HDRS17 Responders	35.8 Percentage of Responders HDRS17	11.7 Percentage of Responders HDRS17

Adverse Events

Adjunct Oral SAMe Tosylate 800mg PO BiD

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Oral Adjunct Placebo

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adjunct Oral SAMe Tosylate 800mg PO BiD n=39 participants at risk Participants receiving the oral SAMe tosylate	Oral Adjunct Placebo n=34 participants at risk Participants receiving placebo
Gastrointestinal disorders Diarrhea	17.9% 7/39 • Number of events 7 • 6 weeks	14.7% 5/34 • Number of events 5 • 6 weeks
Gastrointestinal disorders Upper gastrointestinal upset	35.9% 14/39 • Number of events 14 • 6 weeks	20.6% 7/34 • Number of events 7 • 6 weeks
Nervous system disorders Insomnia	10.3% 4/39 • Number of events 4 • 6 weeks	5.9% 2/34 • Number of events 2 • 6 weeks
Nervous system disorders Somnolence and fatigue	10.3% 4/39 • Number of events 4 • 6 weeks	5.9% 2/34 • Number of events 2 • 6 weeks
Nervous system disorders Headache	10.3% 4/39 • Number of events 4 • 6 weeks	5.9% 2/34 • Number of events 2 • 6 weeks
Nervous system disorders Activation	7.7% 3/39 • Number of events 3 • 6 weeks	11.8% 4/34 • Number of events 4 • 6 weeks
Nervous system disorders Vivid dreams	0.00% 0/39 • 6 weeks	5.9% 2/34 • Number of events 2 • 6 weeks

Additional Information

Dr George Papakostas, M.D.

Massachusetts General Hospital

Phone: 6177266697

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place