Trial Outcomes & Findings for CoQ10 in Geriatric Bipolar Depression (NCT NCT00720369)
NCT ID: NCT00720369
Last Updated: 2014-01-13
Results Overview
The rate constant for creatine kinase is a measurement of the reaction rate ADP+PCr \<---\> ATP + Cr, which is catalyzed by the enzyme creatine kinase. The rate constant shows the direction and magnitude of the reaction at equilibrium. A higher rate constant indicates a higher rate constant of the CK enzyme, meaning, more efficient/rapid conversion of PCr to ATP through the creatine kinase enzymatic reaction in tissues with high and fluctuating energy demands such as brain and muscle tissue. As the value is a reaction rate, there are no associated units.
COMPLETED
NA
42 participants
8 week trial
2014-01-13
Participant Flow
Please note that subjects who sign the informed consent form are considered "enrolled." Only subjects who met eligibility following screening are included in analyses and thus included in the "participant flow." Of the 42 enrolled, 19 started the study and 18 completed.
Participant milestones
| Measure |
CoQ10
Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
|
Healthy Controls
Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
8
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CoQ10 in Geriatric Bipolar Depression
Baseline characteristics by cohort
| Measure |
CoQ10
n=11 Participants
Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
|
Healthy Controls
n=8 Participants
Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
|
Total
n=19 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
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
64.6 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 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
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 week trialThe rate constant for creatine kinase is a measurement of the reaction rate ADP+PCr \<---\> ATP + Cr, which is catalyzed by the enzyme creatine kinase. The rate constant shows the direction and magnitude of the reaction at equilibrium. A higher rate constant indicates a higher rate constant of the CK enzyme, meaning, more efficient/rapid conversion of PCr to ATP through the creatine kinase enzymatic reaction in tissues with high and fluctuating energy demands such as brain and muscle tissue. As the value is a reaction rate, there are no associated units.
Outcome measures
| Measure |
CoQ10
n=10 Participants
Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated.
|
Healthy Controls
n=8 Participants
Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group.
|
|---|---|---|
|
We Measured the Change in Rate Constant of Creatine Kinase in Individuals With Bipolar Depression Treated With CoQ 10 as Compared With Age and Gender Matched Controls. These Rate Constants Were Calculated Using Magnetic Resonance Imaging (MRI).
|
0.02 per second
Standard Deviation 0.002
|
0.03 per second
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: 8 week trialPopulation: Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.
The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 question questionnaire which assesses symptom severity of depression. The score is on a 0-60 scale with higher numbers indicating more severe depressive symptoms. The score is represented as a number of points. Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.
Outcome measures
| Measure |
CoQ10
n=10 Participants
Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated.
|
Healthy Controls
Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group.
|
|---|---|---|
|
We Measured Response to Treatment of Depression (Using the Montgomery Asberg Depression Rating Scale)in Older Adults With Bipolar Disorder After an 8 Week Trial of CoQ10.
Pre-Treatment (baseline)
|
21.4 units on a scale
Standard Deviation 5.5
|
—
|
|
We Measured Response to Treatment of Depression (Using the Montgomery Asberg Depression Rating Scale)in Older Adults With Bipolar Disorder After an 8 Week Trial of CoQ10.
Post-Treatment (week 8)
|
18.4 units on a scale
Standard Deviation 7.3
|
—
|
Adverse Events
CoQ10
Healthy Controls
Serious adverse events
| Measure |
CoQ10
n=11 participants at risk
Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
|
Healthy Controls
n=8 participants at risk
Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
chest pain
|
0.00%
0/11
|
12.5%
1/8 • Number of events 1
|
Other adverse events
| Measure |
CoQ10
n=11 participants at risk
Subjects were given open-label, adjunct treatment with CoQ10 with oral dosing between 400-1200mg per day. Dosing was started at 400mg and titrated up to 1200mg as tolerated. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
|
Healthy Controls
n=8 participants at risk
Healthy age matched control subjects do not receive treatment. Controls undergo testing and MRIs to serve as comparison group. This value does not match the value of subjects enrolled because only subjects who were not screen failures are included in this group.
|
|---|---|---|
|
General disorders
discomfort in MRI
|
0.00%
0/11
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
flu like symptoms
|
0.00%
0/11
|
12.5%
1/8 • Number of events 1
|
|
Injury, poisoning and procedural complications
fall
|
9.1%
1/11 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
persistence of pre-existing atrial fibrillation
|
9.1%
1/11 • Number of events 1
|
0.00%
0/8
|
|
Gastrointestinal disorders
diarrhea
|
27.3%
3/11 • Number of events 3
|
0.00%
0/8
|
|
Gastrointestinal disorders
constipation
|
9.1%
1/11 • Number of events 1
|
0.00%
0/8
|
|
General disorders
hair loss
|
9.1%
1/11 • Number of events 1
|
0.00%
0/8
|
|
Eye disorders
eye pain
|
9.1%
1/11 • Number of events 2
|
0.00%
0/8
|
|
Nervous system disorders
headache
|
18.2%
2/11 • Number of events 2
|
0.00%
0/8
|
|
Nervous system disorders
dizziness
|
9.1%
1/11 • Number of events 1
|
0.00%
0/8
|
|
Injury, poisoning and procedural complications
food poisoning
|
9.1%
1/11 • Number of events 1
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place