Trial Outcomes & Findings for SAM-e for the Treatment of Depression in Patients With Parkinson's Disease (NCT NCT00070941)
NCT ID: NCT00070941
Last Updated: 2016-07-13
Results Overview
very severe, \>23/29; severe, 19-22/29; moderate, 14-18/29; mild, 8-13/29; and no depression, 0-7/29 (Hamilton M., J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
29 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-07-13
Participant Flow
The recruitment dates 01NOV2006-31OCT2008 locations: James Godbold, PH.D. Mount Sinai School of Medicine Steven Ferrando, MD - Weill Medical College of Cornell University Teodoro Bottiglieri, Ph.D. - Baylor College of Medicine Dr. Peter Werner - Albert Einstein College of Medicine
Participant milestones
| Measure |
SAM-e
SAM-e, 1200mg or 2400 mg
|
Escitalopram
oral Escitalopram 10mg or 20m
|
Placebo Comparator
oral placebo Escitalopram and placebo SAM-e
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
6
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
4
|
Reasons for withdrawal
| Measure |
SAM-e
SAM-e, 1200mg or 2400 mg
|
Escitalopram
oral Escitalopram 10mg or 20m
|
Placebo Comparator
oral placebo Escitalopram and placebo SAM-e
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
8
|
4
|
Baseline Characteristics
SAM-e for the Treatment of Depression in Patients With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
SAM-e
n=12 Participants
oral SAM-e, 1200mg or 2400 mg
|
Escitalopram
n=11 Participants
oral Escitalopram 10mg or 20m
|
Placebo Comparator
n=6 Participants
oral placebo Escitalopram and placebo SAM-e
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
11 participants
n=4 Participants
|
6 participants
n=27 Participants
|
29 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 12 weeksvery severe, \>23/29; severe, 19-22/29; moderate, 14-18/29; mild, 8-13/29; and no depression, 0-7/29 (Hamilton M., J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.)
Outcome measures
| Measure |
SAM-e
n=12 Participants
SAM-e, 1200mg or 2400 mg
|
Escitalopram
n=8 Participants
oral Escitalopram 10mg or 20m
|
Placebo Comparator
n=4 Participants
oral placebo Escitalopram and placebo SAM-e
|
|---|---|---|---|
|
Change in Hamilton Depression Scale
Baseline Visit Measurement
|
17 units on a scale
Standard Deviation 4.8
|
17.5 units on a scale
Standard Deviation 5.4
|
20.7 units on a scale
Standard Deviation 3.2
|
|
Change in Hamilton Depression Scale
Week 12 Measurement
|
11.4 units on a scale
Standard Deviation 7.3
|
5.3 units on a scale
Standard Deviation 3.3
|
16.2 units on a scale
Standard Deviation 3.6
|
Adverse Events
SAM-e
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Oral Escitalopram
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SAM-e
n=12 participants at risk
Group A/Forty patients receiving oral SAM-e, 1200mg or 2400 mg
|
Oral Escitalopram
n=11 participants at risk
Group B/Forty patients receiving oral Escitalopram 10mg or 20m
|
Placebo
n=6 participants at risk
Group C/Twenty patients receiving oral placebo Escitalopram an
|
|---|---|---|---|
|
Vascular disorders
Hypotension Orthostatic
|
8.3%
1/12
|
0.00%
0/11
|
0.00%
0/6
|
|
Infections and infestations
Abscess
|
0.00%
0/12
|
0.00%
0/11
|
16.7%
1/6
|
|
General disorders
Death
|
0.00%
0/12
|
0.00%
0/11
|
16.7%
1/6
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12
|
0.00%
0/11
|
16.7%
1/6
|
Other adverse events
| Measure |
SAM-e
n=12 participants at risk
Group A/Forty patients receiving oral SAM-e, 1200mg or 2400 mg
|
Oral Escitalopram
n=11 participants at risk
Group B/Forty patients receiving oral Escitalopram 10mg or 20m
|
Placebo
n=6 participants at risk
Group C/Twenty patients receiving oral placebo Escitalopram an
|
|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
16.7%
2/12
|
0.00%
0/11
|
0.00%
0/6
|
|
Psychiatric disorders
AGITATION
|
25.0%
3/12
|
9.1%
1/11
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
ANOREXIA
|
41.7%
5/12
|
18.2%
2/11
|
33.3%
2/6
|
|
Psychiatric disorders
ANXIETY
|
8.3%
1/12
|
0.00%
0/11
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
APPETITE DECREASED
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/6
|
|
Ear and labyrinth disorders
BALANCE DIFFICULTY
|
0.00%
0/12
|
18.2%
2/11
|
0.00%
0/6
|
|
Gastrointestinal disorders
BLOATING
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/6
|
|
Vascular disorders
BLOOD PRESSURE INCREASED
|
0.00%
0/12
|
0.00%
0/11
|
16.7%
1/6
|
|
Cardiac disorders
CHEST PAIN
|
8.3%
1/12
|
0.00%
0/11
|
0.00%
0/6
|
|
Psychiatric disorders
CONFUSION
|
16.7%
2/12
|
0.00%
0/11
|
0.00%
0/6
|
|
Gastrointestinal disorders
CONSTIPATION
|
50.0%
6/12
|
18.2%
2/11
|
50.0%
3/6
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
8.3%
1/12
|
9.1%
1/11
|
0.00%
0/6
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.3%
1/12
|
0.00%
0/11
|
16.7%
1/6
|
|
Nervous system disorders
DIZZINESS
|
16.7%
2/12
|
36.4%
4/11
|
50.0%
3/6
|
|
Nervous system disorders
DROWSINESS
|
33.3%
4/12
|
18.2%
2/11
|
33.3%
2/6
|
|
Nervous system disorders
DYSKINESIA
|
0.00%
0/12
|
0.00%
0/11
|
16.7%
1/6
|
|
Psychiatric disorders
EXCITABILITY
|
8.3%
1/12
|
0.00%
0/11
|
16.7%
1/6
|
|
Nervous system disorders
FAINTNESS
|
8.3%
1/12
|
27.3%
3/11
|
50.0%
3/6
|
|
Injury, poisoning and procedural complications
FALL
|
16.7%
2/12
|
9.1%
1/11
|
33.3%
2/6
|
|
Psychiatric disorders
HALLUCINATION AUDITORY
|
0.00%
0/12
|
0.00%
0/11
|
16.7%
1/6
|
|
Psychiatric disorders
HALLUCINATION VISUAL
|
0.00%
0/12
|
0.00%
0/11
|
33.3%
2/6
|
|
Nervous system disorders
HEADACHE
|
25.0%
3/12
|
36.4%
4/11
|
16.7%
1/6
|
|
Vascular disorders
HYPOTENSION ORTHOSTATIC
|
8.3%
1/12
|
0.00%
0/11
|
16.7%
1/6
|
|
Eye disorders
INDIGESTION
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/6
|
|
Psychiatric disorders
INSOMNIA
|
33.3%
4/12
|
27.3%
3/11
|
83.3%
5/6
|
|
Injury, poisoning and procedural complications
LEG PAIN
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/6
|
|
Nervous system disorders
LETHARGY
|
8.3%
1/12
|
0.00%
0/11
|
0.00%
0/6
|
|
Psychiatric disorders
LIBIDO DECREASED
|
8.3%
1/12
|
0.00%
0/11
|
0.00%
0/6
|
|
Gastrointestinal disorders
MOUTH DRY
|
25.0%
3/12
|
36.4%
4/11
|
50.0%
3/6
|
|
Musculoskeletal and connective tissue disorders
MUSCLE RIGIDITY
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/6
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
4/12
|
27.3%
3/11
|
83.3%
5/6
|
|
General disorders
PAIN
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
POLYCYTHAEMIA
|
0.00%
0/12
|
0.00%
0/11
|
16.7%
1/6
|
|
Gastrointestinal disorders
STOMACH UPSET
|
8.3%
1/12
|
0.00%
0/11
|
0.00%
0/6
|
|
Nervous system disorders
SYNCOPE
|
8.3%
1/12
|
0.00%
0/11
|
0.00%
0/6
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/12
|
18.2%
2/11
|
16.7%
1/6
|
|
Nervous system disorders
TREMOR
|
33.3%
4/12
|
27.3%
3/11
|
33.3%
2/6
|
|
Nervous system disorders
TREMOR COARSE
|
0.00%
0/12
|
0.00%
0/11
|
16.7%
1/6
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
8.3%
1/12
|
0.00%
0/11
|
0.00%
0/6
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/12
|
0.00%
0/11
|
16.7%
1/6
|
|
Eye disorders
VISION BLURRED
|
16.7%
2/12
|
45.5%
5/11
|
33.3%
2/6
|
|
Psychiatric disorders
VIVID DREAMING
|
8.3%
1/12
|
0.00%
0/11
|
0.00%
0/6
|
|
Gastrointestinal disorders
VOMITING
|
8.3%
1/12
|
0.00%
0/11
|
16.7%
1/6
|
|
General disorders
WEAKNESS GENERALIZED
|
16.7%
2/12
|
27.3%
3/11
|
50.0%
3/6
|
Additional Information
Dr. Alessandro Di Rocco
NYU Parkinson and Movement Disorders Center
Phone: 212-263-4838
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee According to the NIH -grant that supported this clinical trial all publications must be reported to the grant office prior to the release of publications. Statement from NIH award letter: This includes manuscripts submitted or accepted for publication to the awarding component. Report only those publications resulting directly from this grant and those publications. If there have been no publications, so state.
- Publication restrictions are in place
Restriction type: OTHER