Trial Outcomes & Findings for Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation (NCT NCT01492309)

Results Overview

We measured changes in Hamilton Rating Scale for Depression (HDRS-17) scores from baseline to post-treatment. The HDRS-17 was administered on test days 1, 10, \& 20. Scoring is based on the 17-item scale and scores of 0-7 is generally accepted to be within the normal range, indicating minimal to no depression; scores of 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Change score from baseline to test day 20 (after 20 days of intervention)

Results posted on

2018-04-10

Participant Flow

22 participants were eligible at screening to be enrolled into the treatment arm of the study.

Participant milestones

Participant milestones
Measure	Active TMS 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD	Sham TMS 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active TMS n=11 Participants 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD	Sham TMS n=11 Participants 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD	Total n=22 Participants Total of all reporting groups
Age, Continuous	30.13 Years STANDARD_DEVIATION 5.78 • n=5 Participants	26.41 Years STANDARD_DEVIATION 5.11 • n=7 Participants	28.27 Years STANDARD_DEVIATION 5.65 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Change score from baseline to test day 20 (after 20 days of intervention)

We measured changes in Hamilton Rating Scale for Depression (HDRS-17) scores from baseline to post-treatment. The HDRS-17 was administered on test days 1, 10, \& 20. Scoring is based on the 17-item scale and scores of 0-7 is generally accepted to be within the normal range, indicating minimal to no depression; scores of 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.

Outcome measures

Outcome measures
Measure	Active TMS n=11 Participants 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD	Sham TMS n=11 Participants 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment	-13.909 difference in units on a scale Standard Deviation 5.224	-9.091 difference in units on a scale Standard Deviation 7.582

SECONDARY outcome

Timeframe: Change in concentration from test day 1 to test day 20

Population: Only 4 participants from both the active and sham TMS groups were used in analysis because these participants had BDNF data at both time points. Furthermore, some samples were deemed unusable.

We measured the levels of Brain Derived Neurotrophic Factor (BDNF) concentration across time. BDNF is a protein thought to regulate mood and cognitive functioning and research has suggested that levels may vary by severity of mood symptoms. We obtained BDNF values on test days 1 \& 20.

Outcome measures

Outcome measures
Measure	Active TMS n=4 Participants 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD	Sham TMS n=4 Participants 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS)	146.8775 pg/mL Standard Deviation 235.6441	40.0550 pg/mL Standard Deviation 131.9466

Adverse Events

Active TMS

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Sham TMS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active TMS n=11 participants at risk 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD	Sham TMS n=11 participants at risk 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
Pregnancy, puerperium and perinatal conditions Preterm Birth	27.3% 3/11 • Number of events 3	0.00% 0/11

Other adverse events

Other adverse events
Measure	Active TMS n=11 participants at risk 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD	Sham TMS n=11 participants at risk 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
Nervous system disorders Headaches	36.4% 4/11 • Number of events 17	9.1% 1/11 • Number of events 1

Additional Information

Deborah Kim, MD

UPenn

Phone: 6107261020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place