Trial Outcomes & Findings for Gao NARASD Lithium Study (NCT NCT02909504)
NCT ID: NCT02909504
Last Updated: 2020-07-10
Results Overview
Molecule expression is measured as a function of relative fluorescence intensity. The number derives from a photomultiplier tube which essentially counts photons. Higher numbers mean a higher intensity. The values in the results tables represents change in fluorescence intensity between Baseline and Week 16 across various molecules of interest and compares responders (those who experience a \>=50% decrease in mood symptom severity between baseline and week 16) and non responders (those who did NOT experience a \>=50% decrease in mood symptom severity between baseline and week 16). The rows represent the various molecules that were analyzed.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2020-07-10
Participant Flow
Participant milestones
| Measure |
Lithium
Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \> 0.6 mEq/L
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Lithium
Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \> 0.6 mEq/L
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Subject moved
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Gao NARASD Lithium Study
Baseline characteristics by cohort
| Measure |
Lithium
n=24 Participants
Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \> 0.6 mEq/L
|
|---|---|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 12.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
|
Bipolar Diagnosis
Bipolar I Disorder
|
17 Participants
n=5 Participants
|
|
Bipolar Diagnosis
Bipolar II Disorder
|
7 Participants
n=5 Participants
|
|
Lifetime Generalized Anxiety Disorder (GAD) Diagnosis
|
16 Participants
n=5 Participants
|
|
Lifetime Social Phobia Diagnosis
|
13 Participants
n=5 Participants
|
|
Lifetime Attention Deficit Hyperactivity Disorder (ADHD) Diagnosis
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: While we planned to analyze \~45 molecules of interest, poor quality of antibodies to some proteins \& financial limitations limited us to only 28 proteins. The number of participants analyzed for protein expression differs from baseline characteristic and varies below as not all subjects had high enough levels of a particular protein to be analyzed.
Molecule expression is measured as a function of relative fluorescence intensity. The number derives from a photomultiplier tube which essentially counts photons. Higher numbers mean a higher intensity. The values in the results tables represents change in fluorescence intensity between Baseline and Week 16 across various molecules of interest and compares responders (those who experience a \>=50% decrease in mood symptom severity between baseline and week 16) and non responders (those who did NOT experience a \>=50% decrease in mood symptom severity between baseline and week 16). The rows represent the various molecules that were analyzed.
Outcome measures
| Measure |
Lithium Non Responders
n=9 Participants
Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \> 0.6 mEq/L.
|
Lithium Responders
n=12 Participants
Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \> 0.6 mEq/L.
|
|---|---|---|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
NLRP3
|
30.73 fluorescence intensity
Standard Deviation 5.66
|
26.00 fluorescence intensity
Standard Deviation 7.25
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
PKA C-a
|
24.51 fluorescence intensity
Standard Deviation 5.69
|
23.93 fluorescence intensity
Standard Deviation 7.08
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
PDEB4
|
28.15 fluorescence intensity
Standard Deviation 9.12
|
27.31 fluorescence intensity
Standard Deviation 5.78
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
BAK
|
11.16 fluorescence intensity
Standard Deviation 2.08
|
11.50 fluorescence intensity
Standard Deviation 2.88
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
p-Fyn Yes
|
12.49 fluorescence intensity
Standard Deviation 4.46
|
13.33 fluorescence intensity
Standard Deviation 6.44
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
HMGB1
|
23.18 fluorescence intensity
Standard Deviation 8.69
|
22.61 fluorescence intensity
Standard Deviation 6.58
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
IRS2
|
25.29 fluorescence intensity
Standard Deviation 5.64
|
24.06 fluorescence intensity
Standard Deviation 8.71
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
p-CREB
|
30.78 fluorescence intensity
Standard Deviation 4.34
|
30.46 fluorescence intensity
Standard Deviation 6.55
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
PPAR g
|
21.90 fluorescence intensity
Standard Deviation 4.31
|
21.13 fluorescence intensity
Standard Deviation 5.62
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
TNFAIP3
|
33.74 fluorescence intensity
Standard Deviation 6.16
|
31.17 fluorescence intensity
Standard Deviation 6.64
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
TPH1
|
7.13 fluorescence intensity
Standard Deviation 1.04
|
7.23 fluorescence intensity
Standard Deviation 2.47
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
PKC theta
|
33.8 fluorescence intensity
Standard Deviation 7.11
|
35.81 fluorescence intensity
Standard Deviation 8.71
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
Bcl-2
|
39.72 fluorescence intensity
Standard Deviation 6.89
|
35.87 fluorescence intensity
Standard Deviation 8.94
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
iNOS
|
24.51 fluorescence intensity
Standard Deviation 4.38
|
24.54 fluorescence intensity
Standard Deviation 7.54
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
NR3C1
|
7.33 fluorescence intensity
Standard Deviation 2.16
|
6.69 fluorescence intensity
Standard Deviation 2.64
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
mTor
|
22.87 fluorescence intensity
Standard Deviation 6.41
|
21.07 fluorescence intensity
Standard Deviation 8.60
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
Bcl-2 A1
|
1.37 fluorescence intensity
Standard Deviation 0.20
|
1.19 fluorescence intensity
Standard Deviation 0.30
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
BDNF
|
37.78 fluorescence intensity
Standard Deviation 6.72
|
34.00 fluorescence intensity
Standard Deviation 7.44
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
GSK-3b
|
20.89 fluorescence intensity
Standard Deviation 7.88
|
19.49 fluorescence intensity
Standard Deviation 6.47
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
XBP1
|
1.11 fluorescence intensity
Standard Deviation 0.36
|
0.96 fluorescence intensity
Standard Deviation 0.20
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
MARCKS
|
1.32 fluorescence intensity
Standard Deviation 0.35
|
1.28 fluorescence intensity
Standard Deviation 0.54
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
p-GSK 3b
|
4.01 fluorescence intensity
Standard Deviation 0.78
|
4.11 fluorescence intensity
Standard Deviation 1.54
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
p-GSK 3ab
|
2.29 fluorescence intensity
Standard Deviation 0.64
|
1.93 fluorescence intensity
Standard Deviation 0.55
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
Fyn
|
33.01 fluorescence intensity
Standard Deviation 5.42
|
30.24 fluorescence intensity
Standard Deviation 6.44
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
Timeless
|
1.41 fluorescence intensity
Standard Deviation 0.12
|
1.42 fluorescence intensity
Standard Deviation 0.40
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
PGM1
|
30.96 fluorescence intensity
Standard Deviation 4.57
|
28.58 fluorescence intensity
Standard Deviation 6.64
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
NFKB p-P65
|
15.03 fluorescence intensity
Standard Deviation 6.01
|
14.58 fluorescence intensity
Standard Deviation 8.01
|
|
Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
Calmodulin
|
34.44 fluorescence intensity
Standard Deviation 5.68
|
31.86 fluorescence intensity
Standard Deviation 7.70
|
Adverse Events
Lithium
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lithium
n=24 participants at risk
Lithium: Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels \> 0.6 mEq/L
|
|---|---|
|
General disorders
Increased Thirst
|
25.0%
6/24 • 16 weeks
|
|
General disorders
Dry Mouth
|
8.3%
2/24 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
2/24 • 16 weeks
|
|
Psychiatric disorders
Cognitive Impairment
|
4.2%
1/24 • 16 weeks
|
|
Gastrointestinal disorders
Stomach Upset
|
4.2%
1/24 • 16 weeks
|
|
General disorders
Increased Daytime Sleepiness
|
4.2%
1/24 • 16 weeks
|
|
Eye disorders
Blurred Vision
|
4.2%
1/24 • 16 weeks
|
|
General disorders
Dizziness
|
4.2%
1/24 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Itching
|
4.2%
1/24 • 16 weeks
|
|
Reproductive system and breast disorders
Decreased Sexual Interest
|
4.2%
1/24 • 16 weeks
|
|
General disorders
Hair Loss
|
4.2%
1/24 • 16 weeks
|
|
Renal and urinary disorders
Increased urination
|
8.3%
2/24 • 16 weeks
|
Additional Information
Dr. Keming Gao, MD, PhD
University Hospitals Cleveland Medical Center
Phone: 2168442865
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place