Generalized Anxiety DisorderNCT00616447
rTMS Treatment in Patients With General Anxiety Disorder
A study testing Repetitive transcranial magnetic stimulation in people with Generalized Anxiety Disorder, run by Queen's University at 2 sites in 2 countries.
Trial summary
This study will compare the change detected by a standardized rating scale (Hamilton Anxiety Rating Scale) scores in the active treatment group as compared to sham (placebo) group after 6 weeks of rTMS treatments. It is hoped that 6 weeks of rTMS treatment will lead to improvement of core symptoms in patients with GAD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2008to Nov 2012
- 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
- signed patient informed consent;
- primary GAD diagnosis;
- HARS >=15;
- male/female 18-65 years;
- without GAD pharmacotherapy at least last 2 weeks or if they are taking GAD medication it must be stable for at least 6 weeks prior to the start of the study and not be changed during the 6 weeks of the study treatment phase.
- Individual or group supportive psychotherapy may continue during the study but will not be allowed to start new psychotherapy during the 6 weeks of the study treatment phase.
Who cannot join
- current serious Axis I schizophrenia, bipolar I, MDD;
- other primary Axis I in the opinion of investigator;
- HDRS >=18;
- metallic implant in cranium except mouth;
- severe/unstable medical conditions;
- ect within last 3 months;
Show all 10Show fewer
- history epilepsy;
- neurological disorder leading to increased intracranial pressure;
- severe cardiac disorder/intracardiac lines/pacemakers;
- current suicide risk.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A 12-week, Double-blind, Randomized, Placebo-controlled Multicentered Study Evaluating Efficacy and Safety of High-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Generalized Anxiety Disorder (GAD)
This study will compare the change detected by a standardized rating scale (Hamilton Anxiety Rating Scale) scores in the active treatment group as compared to sham (placebo) group after 6 weeks of rTMS treatments. It is hoped that 6 weeks of rTMS treatment will lead to improvement of core symptoms in patients with GAD.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Repetitive transcranial magnetic stimulation, placebo sham
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
Also called rTMS machine (MagPro, Medtronic).
6 weeks of repetitive transcranial magnetic stimulation . Treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of MT, 20 trains, 9 sec/train, 51 sec ITI applied over right dorsolateral prefrontal cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6.
placebo shamDevice
Also called rTMS machine (MagPro, Medtronic).
Sham treatment will mimic active treatment mentioned above.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Repetitive transcranial magnetic stimulation |
| 2 | Sham comparator | Not described Receives: Device: placebo sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale (ham-a)
Measured: baseline, week 2, 4, 6, 8, 12
Secondary outcomes (5)
Clinical Global Impression
Measured: baseline, 2, 4, 6, 8, 12
Hamilton Depression Rating Scale-21
Measured: baseline, week 2, 4, 6, 8, 12
Pittsburgh Sleep Quality Index
Measured: baseline, week 2, 4, 6, 8, 12
SF-36 QOL version (1)
Measured: baseline, week 2, 4, 6, 8, 12
Visual Analogue Scales
Measured: baseline, week 2, 4, 6, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Military Medical Academy, Bulgaria
- Responsible party
- Principal investigator, Dr. Roumen Milev, Queen's University
- Investigators
- Roumen Milev, MD, Study chair, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616447
- Sponsor's protocol ID
- PSIY-270-07
- Status last verified
- Dec 2015
- First submitted
- 4 Feb 2008
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dilkov D, Hawken ER, Kaludiev E, Milev R. Repetitive transcranial magnetic stimulation of the right dorsal lateral prefrontal cortex in the treatment of generalized anxiety disorder: A randomized, double-blind sham controlled clinical trial. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Aug 1;78:61-65. doi: 10.1016/j.pnpbp.2017.05.018. Epub 2017 May 19.
PubMed 28533148
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Double-blind, Randomized, Placebo-controlled Multicentered Study Evaluating Efficacy and Safety of High-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Generalized Anxiety Disorder (GAD)
- ClinicalTrials.gov ID
- NCT00616447
- Acronym / sponsor ID
- PSIY-270-07
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Military Medical Academy, Bulgaria
- Study start
- Jan 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Feb 2008 (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.
This study will compare the change detected by a standardized rating scale (Hamilton Anxiety Rating Scale) scores in the active treatment group as compared to sham (placebo) group after 6 weeks of rTMS treatments. It is hoped that 6 weeks of rTMS treatment will lead to improvement of core symptoms in patients with GAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Repetitive transcranial magnetic stimulation |
| 2 | Sham comparator | Device: placebo sham |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- signed patient informed consent;
- primary GAD diagnosis;
- HARS >=15;
- male/female 18-65 years;
- without GAD pharmacotherapy at least last 2 weeks or if they are taking GAD medication it must be stable for at least 6 weeks prior to the start of the study and not be changed during the 6 weeks of the study treatment phase.
Key exclusion criteria (10 listed)
- current serious Axis I schizophrenia, bipolar I, MDD;
- other primary Axis I in the opinion of investigator;
- HDRS >=18;
- metallic implant in cranium except mouth;
- severe/unstable medical conditions;
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationAlso: rTMS machine (MagPro, Medtronic).6 weeks of repetitive transcranial magnetic stimulation . Treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of MT, 20 trains, 9 sec/train, 51 sec ITI applied over right dorsolateral prefrontal cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6. | Device | 1 |
| placebo shamAlso: rTMS machine (MagPro, Medtronic).Sham treatment will mimic active treatment mentioned above. | Device | 2 |
Primary outcome
Hamilton Anxiety Rating Scale (ham-a)
Time frame: baseline, week 2, 4, 6, 8, 12
5 secondary outcomes
Clinical Global Impression
Time frame: baseline, 2, 4, 6, 8, 12
Hamilton Depression Rating Scale-21
Time frame: baseline, week 2, 4, 6, 8, 12
Pittsburgh Sleep Quality Index
Time frame: baseline, week 2, 4, 6, 8, 12
SF-36 QOL version (1)
Time frame: baseline, week 2, 4, 6, 8, 12
Visual Analogue Scales
Time frame: baseline, week 2, 4, 6, 8, 12
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 16 Dec 2015.
- Derived from this study: PubMed 28533148Dilkov D, Hawken ER, Kaludiev E, Milev R. Repetitive transcranial magnetic stimulation of the right dorsal lateral prefrontal cortex in the treatment of generalized anxiety disorder: A randomized, double-blind sham controlled clinical trial. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Aug 1;78:61-65. doi: 10.1016/j.pnpbp.2017.05.018. Epub 2017 May 19.
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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.
Roumen Milev, MD study chair
Queen's University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Generalized Anxiety Disorder, run by Queen's University at 2 sites in 2 countries.
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 6 inclusion and 10 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bulgaria, Canada. 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?
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?
Hamilton Anxiety Rating Scale (ham-a) (time frame: baseline, week 2, 4, 6, 8, 12). 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 NCT00616447, which also lists 1 linked publication.
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 Dec 2015.