Anxiety DisordersNCT00872131
Identifying Brain and Genetic Markers of Sertraline Treatment Response in People With Social Anxiety Disorder
An observational study of Anxiety Disorders, run by University of Michigan at 1 site in United States.
Trial summary
This study will attempt to identify gene and brain activity markers that predict whether people with social anxiety disorder will respond to selective serotonin reuptake inhibitor medications. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Sertraline
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2011
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community and outpatient clinic samples
Who may be able to join
- For social anxiety disorder group:
- Current diagnosis of social anxiety disorder, generalized subtype
- Physically healthy, as confirmed by comprehensive medical history, physical exam, and laboratory testing
- For healthy control group:
- Never been diagnosed with either Axis I or Axis II mental disorders
- Physically healthy, as confirmed by comprehensive medical history, physical exam, and laboratory testing
Who cannot join
- Clinically significant medical or neurologic condition
- Diagnosis of primary comorbid anxiety disorder, defined by which disorder is the more debilitating and clinically salient
- History of bipolar disorder or schizophrenia
- Presence of an organic mental syndrome, mental retardation, or pervasive developmental disorder
- Current major depressive disorder or major depression within the past 6 months
- Hamilton Rating Scale for Depression score greater than 18
Show all 16Show fewer
- Alcohol or drug abuse or dependence within the past year
- Current suicidal ideation
- Diagnosis of an Axis II personality disorder, except for avoidant personality disorder
- Treatments with psychotropic or psychoactive medications within the 2 weeks before screening (or 8 weeks for fluoxetine and 4 weeks for monoamine oxidase inhibitors)
- Positive urine drug screen results
- Pregnancy
- Additional exclusion criteria for the functional MRI studies:
- Left-handedness, as determined by standard questionnaire
- Presence of ferrous-containing metals within the body, such as aneurysm clips, shrapnel, or retained particles
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuro-Genetic Markers of SSRI Treatment Response in Social Anxiety Disorder
This study will attempt to identify gene and brain activity markers that predict whether people with social anxiety disorder will respond to selective serotonin reuptake inhibitor medications.
Read the detailed description
Social anxiety disorder (SAD) is an anxiety disorder characterized by excessive fear and avoidance of social situations. Selective serotonin reuptake inhibitors (SSRIs) are a medication commonly prescribed to treat social anxiety disorder, but as many as 50% of people with SAD do not respond to SSRIs. Current theory suggests that neurological functioning and genetics may influence a patient's response to treatment. This study will examine variations in genetics and brain reactivity among people with SAD who do and do not respond to SSRIs. Through this, the study will identify neurological and genetic biomarkers that can predict responsiveness to SSRI treatment in people with SAD.
Participation in this study will last 14 weeks. Both healthy people and people with SAD will be recruited to participate. All participants will complete similar study visits at entry, within 2 weeks of entry, and 12 weeks after that. The first visit, which will occur at study entry, will include screening questionnaires, an interview with research staff, a medical screening, a urine test, and collection of saliva samples for genotyping. The second visit and the last visit, which will be separated by 12 weeks, will involve MRI scans and behavioral tasks to be conducted inside and outside the MRI scanner. Over the 12 weeks between MRI scanning sessions, participants with SAD will take sertraline, a common SSRI, on a daily basis. They will also attend five additional visits during this time to complete assessments of their symptoms. These visits will occur 1, 2, 4, 8, and 12 weeks after starting sertraline treatment. Participants with SAD will therefore be completing a symptom assessment, MRI scans, and behavioral tasks all on the final visit, 12 weeks after the second visit.
- Conditions
- Anxiety Disorders
- Being tested
- Sertraline
- Keywords
- Anxiety, Social Phobia, Generalized Social Anxiety Disorder
- Medical subject headings
- Anxiety Disorders, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
Oral sertraline will begin at 50 mg per day, then increase to 75 mg per day on Day 8, then increase to 100 mg per day on Day 15. The dose may be increased to 150 mg per day on Week 8, based on clinical response and medication toleration.
| Study group | Role | What they receive |
|---|---|---|
| Generalized social anxiety disorder participants | Participants with generalized social anxiety disorder will undergo MRI scanning and sertraline treatment. Receives: Drug: Sertraline | |
| Healthy control participants | Healthy control participants will undergo MRI scanning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression (CGI) Scale
Measured: Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment
Secondary outcomes (1)
Liebowitz Social Anxiety Scale (LSAS)
Measured: Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startMar 2008
- Primary completionMay 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, K. Luan Phan, University of Michigan
- Investigators
- K. Luan Phan, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872131
- Sponsor's protocol ID
- K23MH076198
- Other IDs
- K23MH076198, DAHBR 9A-ASPI, 5K23MH076198
- Status last verified
- Nov 2011
- First submitted
- 30 Mar 2009
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-Genetic Markers of SSRI Treatment Response in Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00872131
- Acronym / sponsor ID
- K23MH076198
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety, Social Phobia, Generalized Social Anxiety Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 31 Mar 2009 (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 attempt to identify gene and brain activity markers that predict whether people with social anxiety disorder will respond to selective serotonin reuptake inhibitor medications.
Detailed description
Social anxiety disorder (SAD) is an anxiety disorder characterized by excessive fear and avoidance of social situations. Selective serotonin reuptake inhibitors (SSRIs) are a medication commonly prescribed to treat social anxiety disorder, but as many as 50% of people with SAD do not respond to SSRIs. Current theory suggests that neurological functioning and genetics may influence a patient's response to treatment. This study will examine variations in genetics and brain reactivity among people with SAD who do and do not respond to SSRIs. Through this, the study will identify neurological and genetic biomarkers that can predict responsiveness to SSRI treatment in people with SAD.
Participation in this study will last 14 weeks. Both healthy people and people with SAD will be recruited to participate. All participants will complete similar study visits at entry, within 2 weeks of entry, and 12 weeks after that. The first visit, which will occur at study entry, will include screening questionnaires, an interview with research staff, a medical screening, a urine test, and collection of saliva samples for genotyping. The second visit and the last visit, which will be separated by 12 weeks, will involve MRI scans and behavioral tasks to be conducted inside and outside the MRI scanner. Over the 12 weeks between MRI scanning sessions, participants with SAD will take sertraline, a common SSRI, on a daily basis. They will also attend five additional visits during this time to complete assessments of their symptoms. These visits will occur 1, 2, 4, 8, and 12 weeks after starting sertraline treatment. Participants with SAD will therefore be completing a symptom assessment, MRI scans, and behavioral tasks all on the final visit, 12 weeks after the second visit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generalized social anxiety disorder participants | – | Drug: SertralineParticipants with generalized social anxiety disorder will undergo MRI scanning and sertraline treatment. |
| Healthy control participants | – | –Healthy control participants will undergo MRI scanning. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community and outpatient clinic samples
Key inclusion criteria (6 listed)
- Current diagnosis of social anxiety disorder, generalized subtype
- Physically healthy, as confirmed by comprehensive medical history, physical exam, and laboratory testing
- Never been diagnosed with either Axis I or Axis II mental disorders
- Physically healthy, as confirmed by comprehensive medical history, physical exam, and laboratory testing
Key exclusion criteria (16 listed)
- Clinically significant medical or neurologic condition
- Diagnosis of primary comorbid anxiety disorder, defined by which disorder is the more debilitating and clinically salient
- History of bipolar disorder or schizophrenia
- Presence of an organic mental syndrome, mental retardation, or pervasive developmental disorder
- Current major depressive disorder or major depression 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 |
|---|---|---|
| SertralineAlso: ZoloftOral sertraline will begin at 50 mg per day, then increase to 75 mg per day on Day 8, then increase to 100 mg per day on Day 15. The dose may be increased to 150 mg per day on Week 8, based on clinical response and medication toleration. | Drug | Generalized social anxiety disorder participants |
Primary outcome
Clinical Global Impression (CGI) Scale
Time frame: Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment
1 secondary outcome
Liebowitz Social Anxiety Scale (LSAS)
Time frame: Measured before treatment, at five treatment study visits, and 12 weeks after starting 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 23 Nov 2011.
Related trials for Anxiety Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
K. Luan Phan, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders, run by University of Michigan 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 6 inclusion and 16 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 23 Nov 2011. 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?
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?
Clinical Global Impression (CGI) Scale (time frame: Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment). 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 23 Nov 2011.