Trial Outcomes & Findings for A Trial of SAMe for Treatment-Resistant Bipolar Depression (NCT NCT00762268)

NCT ID: NCT00762268

Last Updated: 2019-02-26

Results Overview

Assessment of current depression symptoms using Montgomery-Asberg Depression Scale (MADRS). All 10 questions on the scale have a 0 (absent)-6(most severe) range for describing symptoms, with the total ranging from 0-60. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: At each weekly visit for 4 weeks
• Results posted on: 2019-02-26

Participant Flow

Participant milestones

Measure	SAMe SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period.	Placebo Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day "rest-period", before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period.
Overall Study STARTED	12	11
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	SAMe SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period.	Placebo Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day "rest-period", before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period.
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

A Trial of SAMe for Treatment-Resistant Bipolar Depression

Baseline characteristics by cohort

Measure	SAMe n=9 Participants SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period.	Placebo n=8 Participants Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day "rest-period", before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period.	Total n=17 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	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	8 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: At each weekly visit for 4 weeks

Assessment of current depression symptoms using Montgomery-Asberg Depression Scale (MADRS). All 10 questions on the scale have a 0 (absent)-6(most severe) range for describing symptoms, with the total ranging from 0-60. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.

Outcome measures

Measure	SAMe n=9 Participants SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period.	Placebo n=8 Participants Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day "rest-period", before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period.
Montgomery-Asberg Depression Scale (MADRS) Baseline	29.4 units on a scale Interval 17.0 to 39.0	28.3 units on a scale Interval 18.0 to 37.0
Montgomery-Asberg Depression Scale (MADRS) Week 1	24.7 units on a scale Interval 10.0 to 37.0	24.2 units on a scale Interval 11.0 to 37.0
Montgomery-Asberg Depression Scale (MADRS) Week 2	26.3 units on a scale Interval 16.0 to 46.0	23.0 units on a scale Interval 8.0 to 37.0
Montgomery-Asberg Depression Scale (MADRS) Week 3	23.7 units on a scale Interval 8.0 to 35.0	18.5 units on a scale Interval 8.0 to 34.0
Montgomery-Asberg Depression Scale (MADRS) Week 4	20.1 units on a scale Interval 8.0 to 31.0	18.1 units on a scale Interval 8.0 to 41.0

SECONDARY outcome

Timeframe: 6-weeks

Rating scale of depression symptoms (range 0-50). A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.

Outcome measures

Measure	SAMe n=7 Participants SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period.	Placebo n=6 Participants Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day "rest-period", before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period.
Hamilton Rating Scale for Depression	11.9 units on a scale Standard Deviation 7.6	7.3 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 6-weeks

Rating scale for manic symptoms (range 0-60). A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.

Outcome measures

Measure	SAMe n=7 Participants SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period.	Placebo n=6 Participants Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day "rest-period", before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period.
Young Mania Rating Scale	2.8 units on a scale Standard Deviation 2.0	1.8 units on a scale Standard Deviation 0.5

Adverse Events

SAMe

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SAMe n=9 participants at risk SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period.	Placebo n=8 participants at risk Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day "rest-period", before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period.
Nervous system disorders Auditory Hallucinations	11.1% 1/9 • Number of events 1	0.00% 0/8

Additional Information

Beth Murphy MD

McLean Hospital

Phone: 617-855-2297

Email: BMurphy5@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place