Major Depressive DisorderTMSNCT01492309

Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation

A study testing Active Transcranial Magnetic Simulation in people with Major Depressive Disorder, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if repetitive transcranial magnetic stimulation (TMS) will alleviate symptoms of major depressive disorder (MDD) in pregnant women. TMS uses electromagnetic impulses to encourage neurons in the brain to communicate more effectively with one another. Read more about this study

Who is it for?: Ages 18 to 39 years, women only
Conditions the study is for: Major Depressive Disorder
What is being tested?: Active Transcranial Magnetic Simulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Nov 2011to Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 39 years
Women only
No healthy volunteers
Adult

Who may be able to join

Subjects are capable of giving written informed consent and complying with all study procedures;
Female age 18-39 years old at date of enrollment;
Pregnant, weeks 14-34;
Current Depressive Symptoms;
No change in antidepressant medication at least two weeks prior to study entry if using an antidepressant.

Who cannot join

Any alcohol or drug abuse/dependence over the 6 months prior to study entry;
History of a seizure disorder in subject or first degree relative;
Anti-psychotic, lithium, or anti-convulsant medications within 2 weeks of study enrollment;
History of known brain lesions, or severe head trauma;
Subjects with any metallic object implanted in the skull;
Subjects with significant cardiac disease;

Show all 13Show fewer

Neurological or psychiatric disorders;
Serious medical illnesses that may compromise patient safety or study conduct;
Currently taking a drug with known potential for fetal toxicity;
Previous pregnancy with an adverse fetal outcome;
Current obstetrical complications
Actively suicidal;
History of depression unresponsive to treatment with electroconvulsive therapy (ECT).

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn Center for Women's Behavioral Wellness
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Transcranial Magnetic Stimulation (TMS) in Pregnant Women With Depressive Disorder

The purpose of this study is to determine if repetitive transcranial magnetic stimulation (TMS) will alleviate symptoms of major depressive disorder (MDD) in pregnant women.

TMS uses electromagnetic impulses to encourage neurons in the brain to communicate more effectively with one another. Effective neuron communication is thought to lead to the lessening of depressive symptoms. In this study subjects require daily TMS treatment for approximately four weeks.

Read the detailed description

We hypothesize that there will be a decline in the Hamilton Rating Scale for Depression (HDRS-17) scores from the beginning to end of treatment. We expect that this decrease will be significantly greater in subjects receiving active transcranial magnetic stimulation (TMS) compared to those receiving placebo TMS. Treatment response will be defined as greater than 50% reduction in HDRS-17 score.

We also hypothesize that levels of Brain Derived Neurotrophic Factor (BDNF), a protein thought to regulate mood and cognitive functioning, will increase in subjects who respond to TMS treatment. We expect BDNF levels to increase by greater than or equal to 20% in those who respond to TMS. As previously stated, TMS response will be defined as a significant decrease (50% or greater) in the HDRS-17 from baseline to end of treatment.

Conditions: Major Depressive Disorder
Being tested: Active Transcranial Magnetic Simulation, Sham Transcranial Magnetic Stimulation
Keywords: Major Depressive Disorder, Pregnancy, Brain Derived Neurotrophic Factor, Transcranial Magnetic Stimulation
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active Transcranial Magnetic SimulationDevice
Also called Neuronetics 2100 CRS TMS System
Subjects will be given active TMS 5 days per week for 4 weeks for a total of 20 sessions. Each session will last approximately 10 minutes.
Sham Transcranial Magnetic StimulationDevice
Also called The eSham System
Subjects will be given sham TMS 5 days per week for 4 weeks for a total of 20 sessions. The sham coil contains a shielding mechanism which diverts the magnetic field away from the patient. The sham treatment will last approximately 10 minutes.

Study groups in NCT01492309
Study group	Role	What they receive
Active Transcranial Magnetic Stimulation	Active comparator	38 pregnant women with MDD will be randomized to receive active 1 Hz right-sided dorsolateral prefrontal cortex (DLPFC) TMS. Receives: Device: Active Transcranial Magnetic Simulation
Sham Transcranial Magnetic Stimulation	Sham comparator	38 pregnant women with MDD will be randomized to receive sham transcranial magnetic stimulation. Receives: Device: Sham Transcranial Magnetic Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment
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.
Measured: Change score from baseline to test day 20 (after 20 days of intervention)

Secondary outcomes (1)

Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS)
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.
Measured: Change in concentration from test day 1 to test day 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Jan 2017

First posted14 Dec 2011 (estimated)
Study startNov 2011
Primary completionJul 2016
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01492309
Sponsor's protocol ID: 812494
Other IDs: K23MH092399
Acronym: TMS
Status last verified: Mar 2018
First submitted: 3 Dec 2011
Last updated: 10 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated device: Yes

Publications

Kim DR, Epperson N, Pare E, Gonzalez JM, Parry S, Thase ME, Cristancho P, Sammel MD, O'Reardon JP. An open label pilot study of transcranial magnetic stimulation for pregnant women with major depressive disorder. J Womens Health (Larchmt). 2011 Feb;20(2):255-61. doi: 10.1089/jwh.2010.2353.
PubMed 21314450
Kim DR, Gonzalez J, O'Reardon JP. Pregnancy and depression: exploring a new potential treatment option. Curr Psychiatry Rep. 2009 Dec;11(6):443-6. doi: 10.1007/s11920-009-0067-0.
PubMed 19909665
Kim D, O'Reardon JP. Editorial: the treatment of depression during pregnancy. Isr J Psychiatry Relat Sci. 2011;48(1):3-5. No abstract available.
PubMed 21572235
Kim DR, O'Reardon JP, Epperson CN. Guidelines for the management of depression during pregnancy. Curr Psychiatry Rep. 2010 Aug;12(4):279-81. doi: 10.1007/s11920-010-0114-x.
PubMed 20424977
Tjoa C, Pare E, Kim DR. Unipolar depression during pregnancy: nonpharmacologic treatment options. Womens Health (Lond). 2010 Jul;6(4):565-76. doi: 10.2217/whe.10.27.
PubMed 20597620

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcranial Magnetic Stimulation (TMS) in Pregnant Women With Depressive Disorder
ClinicalTrials.gov ID: NCT01492309
Acronym / sponsor ID: TMS / 812494
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder, Pregnancy, Brain Derived Neurotrophic Factor, Transcranial Magnetic Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Nov 2011
Primary completion: Jul 2016 (actual)
Study completion: Jan 2017 (actual)
First posted: 14 Dec 2011 (estimated)
Results: Posted 10 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine if repetitive transcranial magnetic stimulation (TMS) will alleviate symptoms of major depressive disorder (MDD) in pregnant women.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active Transcranial Magnetic Stimulation	Active comparator	Device: Active Transcranial Magnetic Simulation38 pregnant women with MDD will be randomized to receive active 1 Hz right-sided dorsolateral prefrontal cortex (DLPFC) TMS.
Sham Transcranial Magnetic Stimulation	Sham comparator	Device: Sham Transcranial Magnetic Stimulation38 pregnant women with MDD will be randomized to receive sham transcranial magnetic stimulation.

Who may qualify

Ages: 18 to 39 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Subjects are capable of giving written informed consent and complying with all study procedures;
Female age 18-39 years old at date of enrollment;
Pregnant, weeks 14-34;
Current Depressive Symptoms;
No change in antidepressant medication at least two weeks prior to study entry if using an antidepressant.

Key exclusion criteria (13 listed)

Any alcohol or drug abuse/dependence over the 6 months prior to study entry;
History of a seizure disorder in subject or first degree relative;
Anti-psychotic, lithium, or anti-convulsant medications within 2 weeks of study enrollment;
History of known brain lesions, or severe head trauma;
Subjects with any metallic object implanted in the skull;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active Transcranial Magnetic SimulationAlso: Neuronetics 2100 CRS TMS SystemSubjects will be given active TMS 5 days per week for 4 weeks for a total of 20 sessions. Each session will last approximately 10 minutes.	Device	Active Transcranial Magnetic Stimulation
Sham Transcranial Magnetic StimulationAlso: The eSham SystemSubjects will be given sham TMS 5 days per week for 4 weeks for a total of 20 sessions. The sham coil contains a shielding mechanism which diverts the magnetic field away from the patient. The sham treatment will last approximately 10 minutes.	Device	Sham Transcranial Magnetic Stimulation

Primary outcome

Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment
Time frame: 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.

1 secondary outcome

Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS)
Time frame: Change in concentration from test day 1 to test day 20

Results and safety

Results posted to the registry on 10 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active TMS	11	11
Sham TMS	11	11

Primary outcome: Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment

Time frame: Change score from baseline to test day 20 (after 20 days of intervention). Mean (Standard Deviation). Unit: difference in units on a scale

Measure	Active TMS n = 11	Sham TMS n = 11
Value	-13.909 (5.224)	-9.091 (7.582)

Active TMS vs Sham TMS: p = 0.003, Fisher Exact

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active TMS	3 of 11 (27.3%)	4 of 11 (36.4%)	0 of 11
Sham TMS	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21314450Kim DR, Epperson N, Pare E, Gonzalez JM, Parry S, Thase ME, Cristancho P, Sammel MD, O'Reardon JP. An open label pilot study of transcranial magnetic stimulation for pregnant women with major depressive disorder. J Womens Health (Larchmt). 2011 Feb;20(2):255-61. doi: 10.1089/jwh.2010.2353.
Background: PubMed 19909665Kim DR, Gonzalez J, O'Reardon JP. Pregnancy and depression: exploring a new potential treatment option. Curr Psychiatry Rep. 2009 Dec;11(6):443-6. doi: 10.1007/s11920-009-0067-0.
Background: PubMed 21572235Kim D, O'Reardon JP. Editorial: the treatment of depression during pregnancy. Isr J Psychiatry Relat Sci. 2011;48(1):3-5. No abstract available.
Background: PubMed 20424977Kim DR, O'Reardon JP, Epperson CN. Guidelines for the management of depression during pregnancy. Curr Psychiatry Rep. 2010 Aug;12(4):279-81. doi: 10.1007/s11920-010-0114-x.
Background: PubMed 20597620Tjoa C, Pare E, Kim DR. Unipolar depression during pregnancy: nonpharmacologic treatment options. Womens Health (Lond). 2010 Jul;6(4):565-76. doi: 10.2217/whe.10.27.
Program WebsiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cynthia N Epperson, M.D. principal investigator

Penn Center for Women's Behavioral Wellness

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active Transcranial Magnetic Simulation in people with Major Depressive Disorder, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment (time frame: Change score from baseline to test day 20 (after 20 days of intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01492309, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.