Trial Outcomes & Findings for The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder (NCT NCT00719706)
NCT ID: NCT00719706
Last Updated: 2012-07-18
Results Overview
Scores could range from 0 - 72 units on a scale, with 0 representing the least number of depressive symptoms and 72 representing the most number of depressive symptoms.
COMPLETED
PHASE2
40 participants
Baseline to 15 Weeks
2012-07-18
Participant Flow
Recruitment began in August 2008 and ended in May 2011 and took place at a research lab within McLean hospital.
To limit heterogeneity in the imaging sample, we accepted only type I bipolar disorder participants for the imaging component of the study.
Participant milestones
| Measure |
ALCAR/ALA
Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
|
Placebo
Participants taking placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
ALCAR/ALA
Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
|
Placebo
Participants taking placebo.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Protocol Violation
|
3
|
0
|
Baseline Characteristics
The Use of a Mitochondrial Enhancement Treatment in Bipolar Disorder
Baseline characteristics by cohort
| Measure |
ALCAR/ALA
n=20 Participants
Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
|
Placebo
n=20 Participants
Participants taking placebo.
|
Total
n=40 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
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
46 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
45.45 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 15 WeeksPopulation: At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.
Scores could range from 0 - 72 units on a scale, with 0 representing the least number of depressive symptoms and 72 representing the most number of depressive symptoms.
Outcome measures
| Measure |
ALCAR/ALA
n=20 Participants
Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
|
Placebo
n=20 Participants
Participants taking placebo.
|
|---|---|---|
|
The 25-Item Hamilton Depression Rating Scale.
Baseline Data
|
23.3 units on a scale
Standard Deviation 3.5
|
22.1 units on a scale
Standard Deviation 3.2
|
|
The 25-Item Hamilton Depression Rating Scale.
Endpoint Data
|
17.5 units on a scale
Standard Deviation 6.4
|
18.5 units on a scale
Standard Deviation 6.2
|
PRIMARY outcome
Timeframe: Baseline to 15 weeksPopulation: At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.
Scores could range from 0 - 60 units on a scale with 0 representing the least number of depressive symptoms and 60 representing the most number of depressive symptoms.
Outcome measures
| Measure |
ALCAR/ALA
n=20 Participants
Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
|
Placebo
n=20 Participants
Participants taking placebo.
|
|---|---|---|
|
The Montgomery-Asberg Depression Rating Scale
Baseline Data
|
26.9 units on a scale
Standard Deviation 3.1
|
25.9 units on a scale
Standard Deviation 3
|
|
The Montgomery-Asberg Depression Rating Scale
Endpoint Data
|
19.6 units on a scale
Standard Deviation 7.9
|
21.7 units on a scale
Standard Deviation 6.3
|
PRIMARY outcome
Timeframe: Baseline to 15 weeksPopulation: At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.
The scores could range from 0 - 60 units on a scale with 0 representing the least number of manic symptoms and 60 representing the most number of manic symptoms.
Outcome measures
| Measure |
ALCAR/ALA
n=20 Participants
Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
|
Placebo
n=20 Participants
Participants taking placebo.
|
|---|---|---|
|
The Young Mania Rating Scale
Baseline Data
|
2 units on a scale
Standard Deviation 2.1
|
2.4 units on a scale
Standard Deviation 2.1
|
|
The Young Mania Rating Scale
Endpoint Data
|
1.7 units on a scale
Standard Deviation 2.2
|
2.1 units on a scale
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: Baseline to 15 weeksPopulation: At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.
Scores could range from 0 - 7 units on a scale, with 0 representing the least severe ("Normal, not at all ill") and 7 representing the most severe ("Among the most extremely ill patients").
Outcome measures
| Measure |
ALCAR/ALA
n=20 Participants
Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
|
Placebo
n=20 Participants
Participants taking placebo.
|
|---|---|---|
|
Clinical Global Impression-Severity
Endpoint Data
|
4 units on a scale
Standard Deviation 0.9
|
4.2 units on a scale
Standard Deviation 0.7
|
|
Clinical Global Impression-Severity
Baseline Data
|
4.6 units on a scale
Standard Deviation 0.5
|
4.6 units on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: At baseline, the number of participants analyzed was the number entered into the imaging portion of the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 10 participants in each category.
Whole brain total NTP levels as measured by a phosphorus MRS scan on the 4T scanner. The data could range from 0 - 1, with 0 representing the lowest NTP level and 1 representing the highest NTP level.
Outcome measures
| Measure |
ALCAR/ALA
n=10 Participants
Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
|
Placebo
n=10 Participants
Participants taking placebo.
|
|---|---|---|
|
Phosphorus MRS Scans on 4T Scanner
Baseline Data
|
.230 units on a scale
Standard Deviation .009
|
.233 units on a scale
Standard Deviation .009
|
|
Phosphorus MRS Scans on 4T Scanner
Week 1 Data
|
.229 units on a scale
Standard Deviation .011
|
.225 units on a scale
Standard Deviation .008
|
|
Phosphorus MRS Scans on 4T Scanner
Endpoint Data
|
.229 units on a scale
Standard Deviation .006
|
.232 units on a scale
Standard Deviation .005
|
Adverse Events
ALCAR/ALA
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ALCAR/ALA
n=20 participants at risk
Participants taking 1000-3000mg/day of acetyl-l-carnitine PLUS 600-1800mg/day of alpha-lipoic acid.
|
Placebo
n=20 participants at risk
Participants taking placebo.
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
30.0%
6/20 • Baseline to 13 weeks.
|
15.0%
3/20 • Baseline to 13 weeks.
|
|
Renal and urinary disorders
foul-smelling urine
|
25.0%
5/20 • Baseline to 13 weeks.
|
5.0%
1/20 • Baseline to 13 weeks.
|
|
Skin and subcutaneous tissue disorders
rash
|
20.0%
4/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
Gastrointestinal disorders
constipation
|
15.0%
3/20 • Baseline to 13 weeks.
|
5.0%
1/20 • Baseline to 13 weeks.
|
|
Gastrointestinal disorders
dyspepsia
|
15.0%
3/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
Gastrointestinal disorders
nausea
|
10.0%
2/20 • Baseline to 13 weeks.
|
25.0%
5/20 • Baseline to 13 weeks.
|
|
Gastrointestinal disorders
abdominal cramping
|
10.0%
2/20 • Baseline to 13 weeks.
|
15.0%
3/20 • Baseline to 13 weeks.
|
|
Cardiac disorders
chest pain
|
10.0%
2/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
General disorders
restlessness
|
10.0%
2/20 • Baseline to 13 weeks.
|
5.0%
1/20 • Baseline to 13 weeks.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
10.0%
2/20 • Baseline to 13 weeks.
|
5.0%
1/20 • Baseline to 13 weeks.
|
|
Gastrointestinal disorders
vomiting
|
10.0%
2/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
General disorders
sedation
|
10.0%
2/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
10.0%
2/20 • Baseline to 13 weeks.
|
10.0%
2/20 • Baseline to 13 weeks.
|
|
General disorders
dry mouth
|
10.0%
2/20 • Baseline to 13 weeks.
|
5.0%
1/20 • Baseline to 13 weeks.
|
|
General disorders
insomnia
|
5.0%
1/20 • Baseline to 13 weeks.
|
25.0%
5/20 • Baseline to 13 weeks.
|
|
Gastrointestinal disorders
flu-like illness
|
5.0%
1/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
General disorders
fatigue
|
5.0%
1/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
General disorders
headache
|
5.0%
1/20 • Baseline to 13 weeks.
|
15.0%
3/20 • Baseline to 13 weeks.
|
|
Gastrointestinal disorders
blood in stool
|
5.0%
1/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
Eye disorders
blurred vision
|
5.0%
1/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
Psychiatric disorders
word-finding difficulties
|
5.0%
1/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
Endocrine disorders
hirsuitism
|
5.0%
1/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
Vascular disorders
facial flushing
|
5.0%
1/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
General disorders
decreased taste
|
5.0%
1/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
General disorders
salty taste
|
5.0%
1/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
5.0%
1/20 • Baseline to 13 weeks.
|
0.00%
0/20 • Baseline to 13 weeks.
|
|
General disorders
dizziness
|
5.0%
1/20 • Baseline to 13 weeks.
|
5.0%
1/20 • Baseline to 13 weeks.
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/20 • Baseline to 13 weeks.
|
20.0%
4/20 • Baseline to 13 weeks.
|
|
Psychiatric disorders
anxiety
|
0.00%
0/20 • Baseline to 13 weeks.
|
5.0%
1/20 • Baseline to 13 weeks.
|
|
General disorders
sore throat
|
0.00%
0/20 • Baseline to 13 weeks.
|
5.0%
1/20 • Baseline to 13 weeks.
|
|
Skin and subcutaneous tissue disorders
facial acne
|
0.00%
0/20 • Baseline to 13 weeks.
|
5.0%
1/20 • Baseline to 13 weeks.
|
|
Psychiatric disorders
irritability
|
0.00%
0/20 • Baseline to 13 weeks.
|
10.0%
2/20 • Baseline to 13 weeks.
|
|
Gastrointestinal disorders
bloating
|
0.00%
0/20 • Baseline to 13 weeks.
|
5.0%
1/20 • Baseline to 13 weeks.
|
|
General disorders
weight gain
|
0.00%
0/20 • Baseline to 13 weeks.
|
10.0%
2/20 • Baseline to 13 weeks.
|
|
General disorders
tremor
|
0.00%
0/20 • Baseline to 13 weeks.
|
5.0%
1/20 • Baseline to 13 weeks.
|
|
Renal and urinary disorders
urinary frequency
|
0.00%
0/20 • Baseline to 13 weeks.
|
5.0%
1/20 • Baseline to 13 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place