Trial Outcomes & Findings for Research Study of Bipolar Mood Symptoms and Cognitive Problems (NCT NCT00428298)
NCT ID: NCT00428298
Last Updated: 2017-04-11
Results Overview
The RBANS is a brief, independently administered measurement of cognitive decline or improvement. The test is comprised of 12 subtests which comprise 5 domains. The age of the participant and the scores from each domain inform the total RBANS score (Index Score) analyzed in this study. The range for total score is 40-160. If the total score for a subject increases this denotes improved performance on the RBANS. The RBANS was administered at baseline and 16 weeks.
COMPLETED
PHASE2
60 participants
16 weeks
2017-04-11
Participant Flow
Participant milestones
| Measure |
Active Treatment Valacyclovir
Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
|
Placebo Treatment
Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
Second RBANS at Study Exit
|
3
|
3
|
|
Overall Study
COMPLETED
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Research Study of Bipolar Mood Symptoms and Cognitive Problems
Baseline characteristics by cohort
| Measure |
Active Treatment Valacyclovir
n=30 Participants
Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
|
Placebo Treatment
n=30 Participants
Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
|
Total
n=60 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
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 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
|
45 years
STANDARD_DEVIATION 7 • n=5 Participants
|
41 years
STANDARD_DEVIATION 10 • n=7 Participants
|
42 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Participants who completed screening/first visit Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and study completion/last visit RBANS. Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final RBANS scores. Imputed data was used for those participants.
The RBANS is a brief, independently administered measurement of cognitive decline or improvement. The test is comprised of 12 subtests which comprise 5 domains. The age of the participant and the scores from each domain inform the total RBANS score (Index Score) analyzed in this study. The range for total score is 40-160. If the total score for a subject increases this denotes improved performance on the RBANS. The RBANS was administered at baseline and 16 weeks.
Outcome measures
| Measure |
Active Treatment Valacyclovir
n=19 Participants
Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
|
Placebo Treatment
n=22 Participants
Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status at 16 Weeks
|
10.1053 percentage of change
Interval 2.074 to 18.1366
|
3.6364 percentage of change
Interval -0.05218 to 7.7946
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants.
The MADRS is a 10 item depression rating scale administered by a research team member. The MADRS is composed of 10 items with a 7 point fixed rating scale (0-6). A higher score indicates the presence of depressive symptoms.
Outcome measures
| Measure |
Active Treatment Valacyclovir
n=19 Participants
Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
|
Placebo Treatment
n=22 Participants
Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Montgomery Asberg Depression Score at 16 Weeks
Baseline MADRS
|
27.94 units on a scale
Standard Deviation 11.73
|
19.74 units on a scale
Standard Deviation 12.09
|
|
Change From Baseline in Montgomery Asberg Depression Score at 16 Weeks
Final MADRS 16 weeks
|
11.5 units on a scale
Standard Deviation 9.76
|
14.89 units on a scale
Standard Deviation 13.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: Discrepancies in number of participants analyzed are due to subjects who dropped out and did not have final assessments. Imputed data was used for those participants.
The Young Mania Rating Scale has 11 items that rate the subject's subjective experience and clinician observation. Four items are rated 0-8, the remaining are rated 0-4. The score can range from 0 to 60. A higher score indicates the presence of manic symptoms.
Outcome measures
| Measure |
Active Treatment Valacyclovir
n=19 Participants
Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
|
Placebo Treatment
n=22 Participants
Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Young Mania Rating Scale (YMRS) at 16 Weeks
Baseline YMRS
|
7.88 units on a scale
Standard Deviation 5.84
|
8.84 units on a scale
Standard Deviation 8.08
|
|
Change From Baseline in Young Mania Rating Scale (YMRS) at 16 Weeks
Final YMRS 16 weeks
|
5.19 units on a scale
Standard Deviation 5.67
|
4.84 units on a scale
Standard Deviation 5.18
|
Adverse Events
Active Treatment Valacyclovir
Placebo Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer L. Payne MD
Johns Hopkins UNiversity School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place