Generalized Anxiety DisorderNCT01815099
Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder
A study testing rTMS Treatment in people with Generalized Anxiety Disorder, run by Hartford Hospital at 1 site in United States.
Trial summary
We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS) for patients with GAD who were placebo nonresponders in DIEF003523.1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- rTMS Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participated in the study DIEF003523.1, received sham "placebo" TMS and achieved < 50% improvement in HARS at 3 month follow-up.
- Fluency in English
- Capacity to understand the nature of the study and willingness to sign informed consent form
Who cannot join
- History of epilepsy or head trauma (LOC > 5 minutes) within the past 6 months
- Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis, or brain surgery
- A review of patient medications by the study physician indicates an increased risk of seizure
- An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency
- Substance use disorder or PTSD within the past 6 months
- Lifetime bipolar disorder, obsessive-compulsive disorder (OCD), psychotic disorder, mental retardation, or pervasive developmental disorder
Show all 12Show fewer
- Any psychotic features, including dementia or delirium
- Concurrent psychotherapy and unwillingness to discontinue
- Medication change within the past 4 weeks
- Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within the past 6 months
- Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study
- Any contraindication for participation in MRI scan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder: Substudy #2
We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS) for patients with GAD who were placebo nonresponders in DIEF003523.1.
Read the detailed description
We expected to enroll five patients with GAD who failed to respond to a sham (placebo) TMS intervention. In this pilot study we enrolled three participants into a protocol including 10 rTMS sessions (twice a week for five weeks) and one into a protocol including 15 rTMS sessions (three times a week for five weeks). Assessments occurred at pretreatment and at posttreatment.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- rTMS Treatment
- 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.
rTMS TreatmentDevice
Also called Neurostar
Either 10 or 15 rTMS sessions (2 or 3 times/week for 5 weeks, respectively)
| Study group | Role | What they receive |
|---|---|---|
| rTMS Treatment | Experimental | Clinical participants will receive rTMS Receives: Device: rTMS Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.
The Hamilton Anxiety Rating Scale (HARS) is one of the most commonly used and extensively validated outcome measures for anxiety symptoms. The SIGH-A allows for a standardized administration of the HARS. The total score was used in this study. The total score ranges from 0 to 56 with higher scores indicative of more severe anxiety symptoms.
Measured: Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: The remaining eligible participants declined to participate.
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Neuronetics
- Responsible party
- Sponsor
- Investigators
- Gretchen J Diefenbach, Ph.D., Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815099
- Sponsor's protocol ID
- DIEF003523.3
- Status last verified
- Feb 2017
- First submitted
- 4 Sep 2012
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder: Substudy #2
- ClinicalTrials.gov ID
- NCT01815099
- Acronym / sponsor ID
- DIEF003523.3
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The remaining eligible participants declined to participate.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Neuronetics
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Mar 2013 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS) for patients with GAD who were placebo nonresponders in DIEF003523.1.
Detailed description
We expected to enroll five patients with GAD who failed to respond to a sham (placebo) TMS intervention. In this pilot study we enrolled three participants into a protocol including 10 rTMS sessions (twice a week for five weeks) and one into a protocol including 15 rTMS sessions (three times a week for five weeks). Assessments occurred at pretreatment and at posttreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS Treatment | Experimental | Device: rTMS TreatmentClinical participants will receive rTMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participated in the study DIEF003523.1, received sham "placebo" TMS and achieved < 50% improvement in HARS at 3 month follow-up.
- Fluency in English
- Capacity to understand the nature of the study and willingness to sign informed consent form
Key exclusion criteria (12 listed)
- History of epilepsy or head trauma (LOC > 5 minutes) within the past 6 months
- Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis, or brain surgery
- A review of patient medications by the study physician indicates an increased risk of seizure
- An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency
- Substance use disorder or PTSD within the past 6 months
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 |
|---|---|---|
| rTMS TreatmentAlso: NeurostarEither 10 or 15 rTMS sessions (2 or 3 times/week for 5 weeks, respectively) | Device | rTMS Treatment |
Primary outcome
Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.
Time frame: Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session
The Hamilton Anxiety Rating Scale (HARS) is one of the most commonly used and extensively validated outcome measures for anxiety symptoms. The SIGH-A allows for a standardized administration of the HARS. The total score was used in this study. The total score ranges from 0 to 56 with higher scores indicative of more severe anxiety symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gretchen J Diefenbach, Ph.D. principal investigator
Hartford 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 rTMS Treatment in people with Generalized Anxiety Disorder, run by Hartford 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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 10 Apr 2017. 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. 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 2017). 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 The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment. (time frame: Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session). 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 10 Apr 2017.