Bipolar DisorderNCT01932749
The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression
A study testing Transcranial Magnetic stimulation in people with Bipolar Disorder, run by University of Tehran at 1 site in Iran.
Trial summary
The aim of this study is to investigate the effect of repetitive TMS in reduction of depressive symptoms in patients with bipolar disorder. In a randomized, single blind clinical trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be assigned to receive bilateral TMS and unilateral TMS, daily… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Transcranial Magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Aug 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients male and female with the range of 18-65 years of age
- The diagnosis of Bipolar disorder according to DSM-IV-TR
- Completion of consent form
- Being under supervision of a psychiatrist,
- Having BDI>14
- Being able to adhere to treatment schedule,
- Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks .
Who cannot join
- The history of rTMS treatment for any reason
- Intracranial implant and other ferromagnetic materials close to the head
- Cardiac pacemaker
- Drug pumps
- The risk of seizure with any reasons
- High intracranial pressure
Show all 11Show fewer
- The history of epilepsy or seizure in the first relatives
- Any metal in head
- Pregnancy
- Breastfeeding
- High risk of suicide 12 Having personality disorder in axis II
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Effectiveness of Bilateral rTMS Versus Unilateral TMS in Patients With Bipolar Depression: a Study Randomized and Single Blind
The aim of this study is to investigate the effect of repetitive TMS in reduction of depressive symptoms in patients with bipolar disorder. In a randomized, single blind clinical trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be assigned to receive bilateral TMS and unilateral TMS, daily; for 20 sessions. The depressive and anxiety symptoms and quality of life will be assessed before the treatment (pre test) during the treatment (10th session), and after the treatment (post test). QEEG apply before and after rTMS in all subjects.
- Conditions
- Bipolar Disorder
- Being tested
- Transcranial Magnetic stimulation
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic stimulationDevice
Also called Magstim rapid 2
| Study group | Role | What they receive |
|---|---|---|
| bilateral repetitive transcranial magnetic stimulation | Active comparator | Bilateral protocol:
Motor threshold 100% /LDLPFC/10Hz/5 second duration/10 second intertrain/ Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain/ Receives: Device: Transcranial Magnetic stimulation |
| unilateral repetitive transcranial magnetic stimulation | Active comparator | Unilateral protocol:
Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain Receives: Device: Transcranial Magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression severity.Depression will be assessed using the Beck depression inventory
The BDI-II is measured depressive symptoms is administered before treatment, session 10, immediately after treatment.
Measured: Baseline to four weeks
Secondary outcomes (3)
Change in anxiety severity .Anxiety will be assessed using the Beck Anxiety inventory.
The BAI is measured for anxiety and is administered before treatment, session 10, immediately after treatment.
Measured: Test Day 1, 10 & 20
Change in World Health Organization Quality of Life- BREF (WHOQOL-BREF)
The WHOQOL-BREF is administered for measuring of quality of life before treatment, session 10, immediately after treatment
Measured: Test Day 1, 10& 20
Change in QEEG and low resolution brain electromagnetic tomography (LORETA)
QEEG and LORETA is applying for assessment brain waves patterns
Measured: Before treatment, immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tehran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reza kazemi, The Neuroscience Center, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932749
- Sponsor's protocol ID
- 143
- Status last verified
- Apr 2014
- First submitted
- 22 Aug 2013
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Effectiveness of Bilateral rTMS Versus Unilateral TMS in Patients With Bipolar Depression: a Study Randomized and Single Blind
- ClinicalTrials.gov ID
- NCT01932749
- Acronym / sponsor ID
- 143
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of TehranUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effect of repetitive TMS in reduction of depressive symptoms in patients with bipolar disorder. In a randomized, single blind clinical trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be assigned to receive bilateral TMS and unilateral TMS, daily; for 20 sessions. The depressive and anxiety symptoms and quality of life will be assessed before the treatment (pre test) during the treatment (10th session), and after the treatment (post test). QEEG apply before and after rTMS in all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bilateral repetitive transcranial magnetic stimulation | Active comparator | Device: Transcranial Magnetic stimulationBilateral protocol: Motor threshold 100% /LDLPFC/10Hz/5 second duration/10 second intertrain/ Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain/ |
| unilateral repetitive transcranial magnetic stimulation | Active comparator | Device: Transcranial Magnetic stimulationUnilateral protocol: Motor threshold 120% /RDLPFC/1Hz/10 second duration/2second intertrain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Outpatients male and female with the range of 18-65 years of age
- The diagnosis of Bipolar disorder according to DSM-IV-TR
- Completion of consent form
- Being under supervision of a psychiatrist,
- Having BDI>14
Key exclusion criteria (11 listed)
- The history of rTMS treatment for any reason
- Intracranial implant and other ferromagnetic materials close to the head
- Cardiac pacemaker
- Drug pumps
- The risk of seizure with any reasons
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 |
|---|---|---|
| Transcranial Magnetic stimulationAlso: Magstim rapid 2 | Device | bilateral repetitive transcranial magnetic stimulation, unilateral repetitive transcranial magnetic stimulation |
Primary outcome
Change in depression severity.Depression will be assessed using the Beck depression inventory
Time frame: Baseline to four weeks
The BDI-II is measured depressive symptoms is administered before treatment, session 10, immediately after treatment.
3 secondary outcomes
Change in anxiety severity .Anxiety will be assessed using the Beck Anxiety inventory.
Time frame: Test Day 1, 10 & 20
Change in World Health Organization Quality of Life- BREF (WHOQOL-BREF)
Time frame: Test Day 1, 10& 20
Change in QEEG and low resolution brain electromagnetic tomography (LORETA)
Time frame: Before treatment, immediately after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic stimulation in people with Bipolar Disorder, run by University of Tehran at 1 site in Iran.
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 7 inclusion and 11 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 7 Apr 2014. 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 Iran. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 depression severity.Depression will be assessed using the Beck depression inventory (time frame: Baseline to four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2014.