Trial Outcomes & Findings for A Single Blind Study of Cranial Electrical Stimulation in Bipolar II Disorder (NCT NCT01909011)
NCT ID: NCT01909011
Last Updated: 2015-12-24
Results Overview
BDI is a validated, self-report measure used to assess the level of depression symptom severity. BDI values range from 0 (normal) to 63 (extreme depression). Mean Change = (Week 2 Mean Score - Baseline Mean Score).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Baseline to Week 2
Results posted on
2015-12-24
Participant Flow
Participant milestones
| Measure |
Active CES
The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.
FW -100 Fisher Wallace Cranial Electrical Stimulator: The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.
|
Sham CES
The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks.
Sham CES via FW-100 Fisher Wallace Stimulator: The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single Blind Study of Cranial Electrical Stimulation in Bipolar II Disorder
Baseline characteristics by cohort
| Measure |
Active CES
n=7 Participants
The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.
FW -100 Fisher Wallace Cranial Electrical Stimulator: The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.
|
Sham CES
n=9 Participants
The CES sham group will receive sham CES (device off)for 20 minutes 5 times per week for two weeks.
Sham CES via FW-100 Fisher Wallace Stimulator: The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.57 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
43.78 years
STANDARD_DEVIATION 18.26 • n=7 Participants
|
47.62 years
STANDARD_DEVIATION 15.88 • n=5 Participants
|
|
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
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 2Population: Intent to treat population (all participants who received at least one dose of intervention). Last observation carried forward (LOCF) imputation method.
BDI is a validated, self-report measure used to assess the level of depression symptom severity. BDI values range from 0 (normal) to 63 (extreme depression). Mean Change = (Week 2 Mean Score - Baseline Mean Score).
Outcome measures
| Measure |
Active
n=7 Participants
Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
|
Sham
n=9 Participants
Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
|
|---|---|---|
|
Change From Baseline in Mean Beck Depression Inventory (BDI) Score at Week 2
|
-13.01 units on a scale
Standard Deviation 6.95
|
-3.76 units on a scale
Standard Deviation 6.44
|
SECONDARY outcome
Timeframe: Baseline to Week 2Q-LES-Q is a validated 16-item self-report measure of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning such as physical well-being, work, home, social relationships and leisure activities. Each item is rated on a 1 - 5 point scale. Q-LES-Q values range from 0 (very low quality of life) to 100 (high quality of life). Mean Change = (Week 2 Mean Score - Baseline Mean Score).
Outcome measures
| Measure |
Active
n=7 Participants
Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
|
Sham
n=9 Participants
Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
|
|---|---|---|
|
Change From Baseline in Mean Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at Week 2
|
18.50 units on a scale
Standard Deviation 18.53
|
-1.50 units on a scale
Standard Deviation 15.86
|
SECONDARY outcome
Timeframe: Baseline to Week 2CGI-S instrument measures the level of severity of illness rated by a qualified clinician. CGI-S values range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). Mean Change = (Week 2 Mean Score - Baseline Mean Score).
Outcome measures
| Measure |
Active
n=7 Participants
Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
|
Sham
n=9 Participants
Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
|
|---|---|---|
|
Change From Baseline in Mean Clinical Global Impressions Illness Severity (CGI-S) Score at Week 2
|
-0.86 units on a scale
Standard Deviation 0.69
|
-0.11 units on a scale
Standard Deviation 0.78
|
Adverse Events
Active
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active
n=7 participants at risk
Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for four weeks.
|
Sham
n=9 participants at risk
Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks (placebo period), and after cross-over into open-label phase participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for another two weeks.
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|---|---|---|
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Nervous system disorders
Drowsiness
|
57.1%
4/7 • Four weeks for active treatment and two weeks for sham treatment
Safety population included all participants who received at least one doze of intervention. Assessments were made before and after each intervention using a side-effects questionnaire.
|
66.7%
6/9 • Four weeks for active treatment and two weeks for sham treatment
Safety population included all participants who received at least one doze of intervention. Assessments were made before and after each intervention using a side-effects questionnaire.
|
|
Eye disorders
Blurred Vision
|
42.9%
3/7 • Four weeks for active treatment and two weeks for sham treatment
Safety population included all participants who received at least one doze of intervention. Assessments were made before and after each intervention using a side-effects questionnaire.
|
22.2%
2/9 • Four weeks for active treatment and two weeks for sham treatment
Safety population included all participants who received at least one doze of intervention. Assessments were made before and after each intervention using a side-effects questionnaire.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Four weeks for active treatment and two weeks for sham treatment
Safety population included all participants who received at least one doze of intervention. Assessments were made before and after each intervention using a side-effects questionnaire.
|
11.1%
1/9 • Four weeks for active treatment and two weeks for sham treatment
Safety population included all participants who received at least one doze of intervention. Assessments were made before and after each intervention using a side-effects questionnaire.
|
|
Nervous system disorders
Headache
|
71.4%
5/7 • Four weeks for active treatment and two weeks for sham treatment
Safety population included all participants who received at least one doze of intervention. Assessments were made before and after each intervention using a side-effects questionnaire.
|
77.8%
7/9 • Four weeks for active treatment and two weeks for sham treatment
Safety population included all participants who received at least one doze of intervention. Assessments were made before and after each intervention using a side-effects questionnaire.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place