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New treatment option for Social Anxiety Disorder
Official title Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety
ClinicalTrials.gov ID: NCT05683223
What this study is testing
What is Sertraline?
Sertraline is an investigational medicine, being studied as a potential treatment for social anxiety disorder.
Also referred to as Non-responder Meds.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical trial is to answer the question: can the investigators predict which adults with social anxiety disorder (SAD) will successfully respond to treatment? To answer this question, the investigators plan to recruit 190 adult participants who experience extreme forms of social anxiety to undergo brain imaging before and after 12 weeks of group cognitive behavioral therapy (CBT).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- for all participants: (1) Any gender or race between 18-50 years old. Additional for healthy controls: (1) Liebowitz Social Anxiety Scale (LSAS...
- Outpatients with a primary psychiatric complaint (designated by the patient as the most important source of current distress) of social anxiety with...
- Overall clinical severity of at least mild as defined by Clinical Global Impressions Scale (CGI-S; Zaider et al., 2003) of at least 3.
- Medical history interview and laboratory findings without clinically significant abnormalities.
- Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol.
You likely can't join if
- A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders or obsessive-compulsive disorder; an eating disorder in the...
- . Patients with significant suicidal ideation Montgomery-Åsberg Depression Rating Scale (10 items, self-report) or who have enacted suicidal...
- Patients can be taking a concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers, sertraline), but the dose must be...
- Significant personality dysfunction likely to interfere with study participation.
- Serious medical illness, associated treatment, or other instability for which hospitalization may be likely within the next year, or which may alter...
- Patients with a current or past history of seizures.
See the full eligibility criteria
- for all participants: (1) Any gender or race between 18-50 years old. Additional for healthy controls: (1) Liebowitz Social Anxiety Scale (LSAS; Mennin et al., 2002) score \<= 30, does not currently meet criteria for an...
- Outpatients with a primary psychiatric complaint (designated by the patient as the most important source of current distress) of social anxiety with social interaction fear as defined by an Liebowitz Social Anxiety...
- Overall clinical severity of at least mild as defined by Clinical Global Impressions Scale (CGI-S; Zaider et al., 2003) of at least 3.
- Medical history interview and laboratory findings without clinically significant abnormalities.
- Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol.
- A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders or obsessive-compulsive disorder; an eating disorder in the past 6 months; organic brain syndrome, intellectual disability, or other...
- . Patients with significant suicidal ideation Montgomery-Åsberg Depression Rating Scale (10 items, self-report) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study...
- Patients can be taking a concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers, sertraline), but the dose must be stabilized for at least 2 weeks prior to initiation of assigned by chance...
- Significant personality dysfunction likely to interfere with study participation.
- Serious medical illness, associated treatment, or other instability for which hospitalization may be likely within the next year, or which may alter fMRI or EEG measurements. Participants with a history of serious...
- Patients with a current or past history of seizures.
- Pregnant women, lactating women, and women of childbearing potential who may become pregnant.
- Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the social anxiety is excluded. Individuals with prior CBT...
- Prior non-response to adequately-delivered exposure (i.e., as defined by the patient's report of receiving specific and regular exposure assignments as part of a previous treatment).
- Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
- Contraindications for MRI including metal implants, surgical clips, probability of metal fragments, braces, or claustrophobia.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.