DepressionLFMSNCT00578383

Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device

A study testing Low Field Magnetic Stimulation Device in people with Depression and Bipolar Depression, run by Mclean Hospital 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

This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some of the symptoms of depression in bipolar disorder or major depression. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Depression, Bipolar Depression, Major Depressive Disorder
What is being tested?: Low Field Magnetic Stimulation Device
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 107 participants
Where: 1 siteUnited States
Study dates: Nov 2007to Mar 2013
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of Major Depressive Disorder or Bipolar Disorder; must be currently depressed
May be medicated or unmedicated

Who cannot join

Contraindication for MRI due to metal in eyes/head
Claustrophobia.
Inability to lie flat.
History of brain injury.
Pregnant
Current drug use/abuse/dependence
History of polysubstance use

Trial locations and contacts

1 site in 1 country.

United States1 site

McLean Hospital
Belmont, Massachusetts, 02478

Other trials in United States

About this study

This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some of the symptoms of depression in bipolar disorder or major depression.

Read the detailed description

This study involves a screening visit with the study physician and a treatment visit. Participants will be asked to complete several questionnaires about their mood during both visits. The treatment visit will involve use of the LFMS device. Participants will place the top of their head inside the device for approximately 20 minutes. Participants will receive either the actual treatment or a sham treatment and will not know which they receive. This device produces weak electromagnetic fields. There is no discomfort or even sensation caused by the device. The device has been declared to be a "non-significant risk device" by the FDA, and there are no known risks associated with its use.

Conditions: Depression, Bipolar Depression, Major Depressive Disorder
Being tested: Low Field Magnetic Stimulation Device
Keywords: Depression, Major depression, Bipolar Disorder, Bipolar depression, LFMS, low field magnetic stimulation, mood disorders, affective disorders
Medical subject headings: Depression, Bipolar Disorder, Depressive Disorder, Major, Mood Disorders

What participants receive

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

Low Field Magnetic Stimulation DeviceDevice
Also called LFMS
The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. Subjects will receive one 20 minute treatment.

Study groups in NCT00578383
Study group	Role	What they receive
Sham (inactive) Treatment BPD	Sham comparator	20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects Receives: Device: Low Field Magnetic Stimulation Device
Active LFMS treatment in BPD	Active comparator	20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects Receives: Device: Low Field Magnetic Stimulation Device
Sham LFMS Comparator: in MD	Sham comparator	20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects Receives: Device: Low Field Magnetic Stimulation Device
Experimental LFMS: in MD	Active comparator	20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects Receives: Device: Low Field Magnetic Stimulation Device

What is being measured

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

Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Measured: Once just before and once just after treatment
Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Measured: Once just before and once just after treatment
Visual Analog Scale (VAS) in Subjects With Bipolar Depression
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Measured: Once just before and once just after treatment
Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Measured: Once just before and once just after treatment

Secondary outcomes (8)

Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Measured: Once just before and once just after treatment
Visual Analog Scale (VAS): Combined Diagnostic Groups.
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Measured: Once just before and once just after treatment
Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Measured: Once just before and once just after treatment
Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Measured: once pre and once post LFMS treatment
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Measured: Once just before and once just after treatment
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Measured: Once just before and once just after treatment
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Measured: once pre and once post LFMS treatment
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder
20 item list of words that describe different feelings and emotions with positive and negative valences (10 each), which the subject scores on a 1-5 scale: 1 = very slightly or not at all 2 = a little 3 = moderate 4 = quite a bit 5 = extremely. Positive and Negative scores are calculated and reported separately and range from 10-50. Higher positive score reflects stronger positive affect and higher negative score reflects stronger negative affect.
Measured: once pre and once post LFMS treatment

Timeline

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

Nov 2007Mar 2013

First posted21 Dec 2007 (estimated)
Study startNov 2007
Primary completionMar 2011
Study completionMar 2013

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 (3)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00578383
Sponsor's protocol ID: 2006-P-001655
Other IDs: Stanley Grant 07TGS-1045
Acronym: LFMS
Status last verified: Apr 2016
First submitted: 18 Dec 2007
Last updated: 16 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Carlezon WA Jr, Rohan ML, Mague SD, Meloni EG, Parsegian A, Cayetano K, Tomasiewicz HC, Rouse ED, Cohen BM, Renshaw PF. Antidepressant-like effects of cranial stimulation within a low-energy magnetic field in rats. Biol Psychiatry. 2005 Mar 15;57(6):571-6. doi: 10.1016/j.biopsych.2004.12.011.
PubMed 15780843
Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. doi: 10.1176/appi.ajp.161.1.93.
PubMed 14702256
Rohan ML, Yamamoto RT, Ravichandran CT, Cayetano KR, Morales OG, Olson DP, Vitaliano G, Paul SM, Cohen BM. Rapid mood-elevating effects of low field magnetic stimulation in depression. Biol Psychiatry. 2014 Aug 1;76(3):186-93. doi: 10.1016/j.biopsych.2013.10.024. Epub 2013 Nov 12.
PubMed 24331545

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?

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device
ClinicalTrials.gov ID: NCT00578383
Acronym / sponsor ID: LFMS / 2006-P-001655
Conditions: Depression, Bipolar Depression, Major Depressive Disorder
Keywords: Depression, Major depression, Bipolar Disorder, Bipolar depression, LFMS, low field magnetic stimulation, mood disorders, affective disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Mclean HospitalUniversity, hospital or other
Collaborators: Stanley Medical Research Institute
Study start: Nov 2007
Primary completion: Mar 2011 (actual)
Study completion: Mar 2013 (actual)
First posted: 21 Dec 2007 (estimated)
Results: Posted 30 Apr 2014

Clinical summary

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

This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some of the symptoms of depression in bipolar disorder or major depression.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Sham (inactive) Treatment BPD	Sham comparator	Device: Low Field Magnetic Stimulation Device20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
Active LFMS treatment in BPD	Active comparator	Device: Low Field Magnetic Stimulation Device20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS)in bipolar depressed subjects
Sham LFMS Comparator: in MD	Sham comparator	Device: Low Field Magnetic Stimulation Device20 minutes of sham treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects
Experimental LFMS: in MD	Active comparator	Device: Low Field Magnetic Stimulation Device20 minutes of active treatment with the Low Field Magnetic Stimulation Device (LFMS) in major depressed subjects

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of Major Depressive Disorder or Bipolar Disorder; must be currently depressed
May be medicated or unmedicated

Key exclusion criteria (7 listed)

Contraindication for MRI due to metal in eyes/head
Claustrophobia.
Inability to lie flat.
History of brain injury.
Pregnant

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
Low Field Magnetic Stimulation DeviceAlso: LFMSThe LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. Subjects will receive one 20 minute treatment.	Device	Active LFMS treatment in BPD, Experimental LFMS: in MD, Sham (inactive) Treatment BPD, Sham LFMS Comparator: in MD

Primary outcome

Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression
Time frame: Once just before and once just after treatment
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder
Time frame: Once just before and once just after treatment
A multiple choice questionnaire used to rate depression severity. Mean change from pretreatment score. 17 items reflecting depression symptoms are scored on scale of severity; 9 items are scored 0 = Absent 1 = Trivial 2 = Mild 3 = Moderate 4 = Severe 8 items are scored 0 = Absent 1 = Mild 2 = Severe. Items are summed; minimum score is 0, maximum score is 52. Higher scores represent more severe depression.
Visual Analog Scale (VAS) in Subjects With Bipolar Depression
Time frame: Once just before and once just after treatment
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.
Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder
Time frame: Once just before and once just after treatment
Eleven point Likert scales indicating immediate depression state. Mean change from pretreatment score. Participant marks an 'X' on a numbered line anchored by 0 = no depression and 10 = most depressed ever been.

8 secondary outcomes

Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item): Combined Diagnostic Groups.
Time frame: Once just before and once just after treatment
Visual Analog Scale (VAS): Combined Diagnostic Groups.
Time frame: Once just before and once just after treatment
Positive and Negative Affect Schedule (PANAS) Positive Score: Combined Diagnostic Group.
Time frame: Once just before and once just after treatment
Positive and Negative Affect Schedule (PANAS) Negative Score: Combined Diagnostic Group.
Time frame: once pre and once post LFMS treatment
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Bipolar Depression.
Time frame: Once just before and once just after treatment
Positive and Negative Affect Schedule (PANAS) Positive Score in Subjects With Major Depressive Disorder
Time frame: Once just before and once just after treatment
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Bipolar Depression
Time frame: once pre and once post LFMS treatment
Positive and Negative Affect Schedule (PANAS) Negative Score in Subjects With Major Depressive Disorder
Time frame: once pre and once post LFMS treatment

Results and safety

Results posted to the registry on 30 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bipolar Disorder Active LFMS Treatment	37	21
Bipolar Disorder Sham LFMS Treatment	36	20
Major Depressive Disorder Active LFMS Treatment	19	13
Major Depressive Disorder Sham LFMS Treatment	15	9

Primary outcome: Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression

Time frame: Once just before and once just after treatment. Mean (Standard Error). Unit: units on a scale

Measure	Bipolar Disorder Active LFMS Treatment n = 19	Bipolar Disorder Sham LFMS Treatment n = 20
Value	-8.3 (1.0)	-5.79 (1.07)

Bipolar Disorder Active LFMS Treatment vs Bipolar Disorder Sham LFMS Treatment: Mean Difference (Net): 2.5 (95% CI -1.2 to 6.2), p = 0.09, Regression, Linear

Population analysed: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.

Primary outcome: Mean Change in Hamilton Depression Depression Rating Scale (HAM-D) (17 Item) in Subjects With Major Depressive Disorder

Time frame: Once just before and once just after treatment. Mean (Standard Error). Unit: units on a scale

Measure	Major Depressive Disorder Active LFMS Treatment n = 10	Major Depressive Disorder Sham LFMS Treatment n = 9
Value	-7.19 (1.44)	-4.02 (1.54)

Major Depressive Disorder Active LFMS Treatment vs Major Depressive Disorder Sham LFMS Treatment: Mean Difference (Net): 3.2 (95% CI -3.3 to 9.6), p = 0.19, Regression, Linear

Population analysed: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.

Primary outcome: Visual Analog Scale (VAS) in Subjects With Bipolar Depression

Time frame: Once just before and once just after treatment. Mean (Standard Error). Unit: units on a scale

Measure	Bipolar Disorder Active LFMS Treatment n = 21	Bipolar Disorder Sham LFMS Treatment n = 20
Value	-1.18 (0.37)	-1.05 (0.35)

Bipolar Disorder Active LFMS Treatment vs Bipolar Disorder Sham LFMS Treatment: Mean Difference (Net): 0.76 (95% CI -0.6 to 2.1), p = 0.15, Regression, Linear

Population analysed: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.

Primary outcome: Visual Analog Scale (VAS) in Subjects With Major Depressive Disorder

Time frame: Once just before and once just after treatment. Mean (Standard Error). Unit: units on a scale

Measure	Major Depressive Disorder Active LFMS Treatment n = 13	Major Depressive Disorder Sham LFMS Treatment n = 9
Value	-1.33 (0.53)	0.25 (0.25)

Major Depressive Disorder Active LFMS Treatment vs Major Depressive Disorder Sham LFMS Treatment: Mean Difference (Net): 1.58 (95% CI -0.4 to 3.6), p = 0.04, Regression, Linear

Population analysed: Qualifying subjects who completed the the study with qualifying HAM-D scores and complete data.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 years, 10 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bipolar Disorder Active LFMS Treatment	0 of 37 (0%)	0 of 37 (0%)	Not reported
Bipolar Disorder Sham LFMS Treatment	0 of 36 (0%)	2 of 36 (5.6%)	Not reported
Major Depressive Disorder Active LFMS Treatment	0 of 19 (0%)	0 of 19 (0%)	Not reported
Major Depressive Disorder Sham LFMS Treatment	0 of 15 (0%)	0 of 15 (0%)	Not reported

Limitations and caveats (from the sponsor): A limitation of the current trial was that it was underpowered to detect moderate but clinically significant benefits of LFMS in diagnostic subgroups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15780843Carlezon WA Jr, Rohan ML, Mague SD, Meloni EG, Parsegian A, Cayetano K, Tomasiewicz HC, Rouse ED, Cohen BM, Renshaw PF. Antidepressant-like effects of cranial stimulation within a low-energy magnetic field in rats. Biol Psychiatry. 2005 Mar 15;57(6):571-6. doi: 10.1016/j.biopsych.2004.12.011.
Background: PubMed 14702256Rohan M, Parow A, Stoll AL, Demopulos C, Friedman S, Dager S, Hennen J, Cohen BM, Renshaw PF. Low-field magnetic stimulation in bipolar depression using an MRI-based stimulator. Am J Psychiatry. 2004 Jan;161(1):93-8. doi: 10.1176/appi.ajp.161.1.93.
Derived from this study: PubMed 24331545Rohan ML, Yamamoto RT, Ravichandran CT, Cayetano KR, Morales OG, Olson DP, Vitaliano G, Paul SM, Cohen BM. Rapid mood-elevating effects of low field magnetic stimulation in depression. Biol Psychiatry. 2014 Aug 1;76(3):186-93. doi: 10.1016/j.biopsych.2013.10.024. Epub 2013 Nov 12.
Link to McLean Hospital clinical study 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.

Michael Rohan, PhD principal investigator

Mclean Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing Low Field Magnetic Stimulation Device in people with Depression and Bipolar Depression, run by Mclean Hospital 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 2 inclusion and 7 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 16 May 2016. 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 30 Apr 2014). 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?

Mean Change in Hamilton Depression Rating Scale (HAM-D) (17 Item) in Subjects With Bipolar Depression (time frame: Once just before and once just after treatment). The study lists 4 primary outcomes in all. 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 NCT00578383, which also lists 3 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 16 May 2016.