Trial Outcomes & Findings for Exploring the Effects of Coenzyme Q10 on Bioenergetics Metabolism in Geriatric Bipolar Depression (NCT NCT01390389)
NCT ID: NCT01390389
Last Updated: 2017-12-07
Results Overview
Tissue-specific (gray or white matter) concentrations of of Phosphocreatine (PCr), Beta-Nucleoside Triphosphate (bNTP), and Inorganic Phosphate (Pi) in geriatric BPD compared with healthy controls at baseline. Concentrations were measured using CSI P MRS scan at 4T. The analysis of signal intensity is done through integration of the area under the curve and is expressed in arbitrary units.
COMPLETED
NA
19 participants
Baseline
2017-12-07
Participant Flow
Bipolar subjects were recruited from the McLean Hospital Geriatric Psychiatry Inpatient and Outpatients services, and similar external programs, as well as through radio and internet advertisements. Controls through contacts with the Harvard Division on Aging, local retirement communities and advertisements on the internet, and senior centers.
Subjects who met DSM-IV diagnostic criteria for Bipolar Disorder and were currently depressed episode were assigned to the CoQ10 group. The CoQ10 group was to receive CoQ10 therapy for 4 weeks. Healthy control subjects no evidence of current or past psychiatric disorders were assigned to the Control group. This group did not receive CoQ10 therapy.
Participant milestones
| Measure |
Control
Healthy controls with no evidence of current or past psychiatric disorders.
|
CoQ10
Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Control
Healthy controls with no evidence of current or past psychiatric disorders.
|
CoQ10
Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Screen Fail
|
2
|
1
|
Baseline Characteristics
Exploring the Effects of Coenzyme Q10 on Bioenergetics Metabolism in Geriatric Bipolar Depression
Baseline characteristics by cohort
| Measure |
Control
n=10 Participants
Healthy controls with no evidence of current or past psychiatric disorders.
|
CoQ10
n=9 Participants
Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
|
Total
n=19 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
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 60.2 • n=93 Participants
|
63 years
STANDARD_DEVIATION 50.05 • n=4 Participants
|
62.21 years
STANDARD_DEVIATION 5.48 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
9 participants
n=4 Participants
|
19 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: BaselineTissue-specific (gray or white matter) concentrations of of Phosphocreatine (PCr), Beta-Nucleoside Triphosphate (bNTP), and Inorganic Phosphate (Pi) in geriatric BPD compared with healthy controls at baseline. Concentrations were measured using CSI P MRS scan at 4T. The analysis of signal intensity is done through integration of the area under the curve and is expressed in arbitrary units.
Outcome measures
| Measure |
Control
n=6 Participants
Healthy controls with no evidence of current or past psychiatric disorders.
|
CoQ10
n=8 Participants
Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
|
CoQ10 Baseline (Week 0)
Subjects with Bipolar disorder who had not yet received study drug.
|
CoQ10 Week 4
Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
|
|---|---|---|---|---|
|
Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline
PCr in Gray Matter
|
4.35 Integration Expressed as Arbitrary Unit
Standard Error 0.16
|
3.94 Integration Expressed as Arbitrary Unit
Standard Error 0.14
|
—
|
—
|
|
Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline
PCr in White Matter
|
3.23 Integration Expressed as Arbitrary Unit
Standard Error 0.15
|
3.06 Integration Expressed as Arbitrary Unit
Standard Error 0.13
|
—
|
—
|
|
Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline
bNTP in Gray Matter
|
2.63 Integration Expressed as Arbitrary Unit
Standard Error 0.13
|
2.30 Integration Expressed as Arbitrary Unit
Standard Error 0.12
|
—
|
—
|
|
Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline
bNTP in White Matter
|
2.43 Integration Expressed as Arbitrary Unit
Standard Error 0.12
|
2.38 Integration Expressed as Arbitrary Unit
Standard Error 0.12
|
—
|
—
|
|
Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline
Pi in Gray Matter
|
1.17 Integration Expressed as Arbitrary Unit
Standard Error 0.06
|
1.39 Integration Expressed as Arbitrary Unit
Standard Error 0.05
|
—
|
—
|
|
Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline
Pi in White Matter
|
1.37 Integration Expressed as Arbitrary Unit
Standard Error 0.04
|
1.23 Integration Expressed as Arbitrary Unit
Standard Error 0.04
|
—
|
—
|
SECONDARY outcome
Timeframe: 4-week trialPopulation: Healthy controls with no evidence of current or past psychiatric disorders, and subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in the CoQ10 group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
Changes in Phosphocreatine and beta NTP (represented as adenosine triphosphate) in gray matter and white matter will be determined by measurements at Week 0 and Week 4 in Geri BD group challenged with CoQ10 and in healthy controls.
Outcome measures
| Measure |
Control
n=6 Participants
Healthy controls with no evidence of current or past psychiatric disorders.
|
CoQ10
n=6 Participants
Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
|
CoQ10 Baseline (Week 0)
n=8 Participants
Subjects with Bipolar disorder who had not yet received study drug.
|
CoQ10 Week 4
n=8 Participants
Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
|
|---|---|---|---|---|
|
To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression.
Gray Matter Phosphocreatine
|
4.350 Integration Expressed as Arbitrary Unit
Standard Error 0.165
|
4.425 Integration Expressed as Arbitrary Unit
Standard Error 0.168
|
3.944 Integration Expressed as Arbitrary Unit
Standard Error 0.143
|
4.435 Integration Expressed as Arbitrary Unit
Standard Error 0.151
|
|
To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression.
White Matter Phosphocreatine
|
3.226 Integration Expressed as Arbitrary Unit
Standard Error 0.150
|
3.424 Integration Expressed as Arbitrary Unit
Standard Error 0.151
|
3.063 Integration Expressed as Arbitrary Unit
Standard Error 0.127
|
2.997 Integration Expressed as Arbitrary Unit
Standard Error 0.132
|
|
To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression.
Gray Matter Adenosine Triphosphate
|
2.620 Integration Expressed as Arbitrary Unit
Standard Error 0.130
|
2.649 Integration Expressed as Arbitrary Unit
Standard Error 0.133
|
2.283 Integration Expressed as Arbitrary Unit
Standard Error 0.113
|
2.088 Integration Expressed as Arbitrary Unit
Standard Error 0.117
|
|
To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression.
White Matter Adenosine Triphosphate
|
2.417 Integration Expressed as Arbitrary Unit
Standard Error 0.120
|
2.148 Integration Expressed as Arbitrary Unit
Standard Error 0.121
|
2.376 Integration Expressed as Arbitrary Unit
Standard Error 0.102
|
2.844 Integration Expressed as Arbitrary Unit
Standard Error 0.105
|
Adverse Events
Control
CoQ10
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=10 participants at risk
Healthy controls with no evidence of current or past psychiatric disorders.
|
CoQ10
n=9 participants at risk
Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
|
|---|---|---|
|
General disorders
Difficulty Sleeping
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Mild Nausea
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Discomfort in MRI
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Reduced Appetite
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10
|
33.3%
3/9 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place