Phase
Condition
Panic Disorders
Mood Disorders
Anxiety Disorders
Treatment
N/AClinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female outpatients between 18 and 65 years of age with a primary psychiatricdiagnosis (designated by the patient as the most important source of current distress)of non-generalized social anxiety disorder (SAD) or Generalized Social AnxietyDisorder (GSAD) with a significant fear of public speaking as defined by DSM-IVcriteria.
Severity of the social phobia of at least 3 on the CGI scale rated for the severity ofpublic speaking anxiety
Willingness and ability to comply with the requirements of the study protocol.
Exclusion
Exclusion Criteria:
A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disordersor obsessive-compulsive disorder; an eating disorder in the past 6 months; organicbrain syndrome, mental retardation or other cognitive dysfunction that could interferewith capacity to engage in therapy; a history of substance (amphetamines,benzodiazepines, barbiturates, cocaine metabolites, marijuana, narcotics, and sedativehypnotics) abuse or dependence or alcohol abuse or dependence (other than nicotine) inthe last 6 months or otherwise unable to commit to refraining from alcohol use duringthe acute period of study participation.
Patients with posttraumatic stress disorder within the past 6 months are excluded.Entry of patients with other mood or anxiety disorders will be permitted if the socialanxiety disorder is judged to be the predominant disorder, in order to increaseaccrual of a clinically relevant sample. Patients with significant suicidal ideation (BDI item 9 score > 1) or who have enacted suicidal behaviors within 6 months prior tointake will be excluded from study participation and referred for appropriate clinicalintervention.
Given that Yohimbine hydrochloride is frequently used as an adjunctive medication inorder to decrease side effects commonly resulting from antidepressant use (Pollack &Smoller, 1996), antidepressant and anxiolytic medications are acceptable if they arestabilized for at least 8 weeks prior to the baseline assessments. However,individuals taking monoamine oxidase inhibitors or tricyclic antidepressants will beexcluded from the study unless they are able and willing to discontinue thesemedications prior to baseline screening.
Individuals taking antihistamines or strattera (atomoxetine) will be excluded from thestudy unless they are able and willing to discontinue these medications prior tobaseline screening
Evidence through interview or physical exam of significant general medical condition (e.g renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologicor cerebrovascular disease, or malignancy) that may interfere with the interpretationof safety and efficacy evaluations in the opinion of the prescribing physician.
Resting blood pressure ≥ 160 systolic and/or 100 diastolic. Individuals currentlybeing treated for high blood pressure and meeting these criteria are eligible.
Significant personality dysfunction likely to interfere with study participation.
Patients with a current or past history of seizures
Pregnant women, lactating women, and women of childbearing potential who are not usingmedically accepted forms of contraception (e.g., IUD, oral contraceptives, barrierdevices, condoms and foam, or implanted progesterone rods stabilized for at least 3months). A urine pregnancy test will be performed on all female subjects ofchild-bearing potential at the screening visit.
Any concurrent psychotherapy initiated within 3 months of baseline, or ongoingpsychotherapy of any duration directed specifically toward treatment of the SAD isexcluded. Prohibited psychotherapy includes CBT or psychodynamic therapy focusing onexploring specific, dynamic causes of the phobic symptomatology and providesmanagement skills. General supportive therapy initiated > 3 months prior isacceptable.
Prior non-response to adequately-delivered exposure (i.e., as defined by the patient'sreport of receiving specific and regular exposure assignments as part of a previoustreatment) will exclude participants from the study.
Patients with a history of head trauma causing loss of consciousness, seizure orongoing cognitive impairment.
Patients unable to understand study procedures and participate in the informed consentprocess.
Study Design
Study Description
Connect with a study center
Boston University
Boston, Massachusetts 02215
United StatesSite Not Available
Southern Methodist University
Dallas, Texas 75206
United StatesSite Not Available
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