Flushing in Social Anxiety Disorder on Seroquel

Last updated: February 24, 2014
Sponsor: START Clinic for Mood and Anxiety Disorders
Overall Status: Completed

Phase

3

Condition

Anxiety Disorders

Panic Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00773162
AzSeroSP
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To add to our understanding of the relationship between blushing, symptom severity and potential mechanisms that underlie blushing in patients with Social Phobia (SP), the investigators propose comparing SP patients' vascular responses to topical m-N pre and post treatment with Seroquel or placebo.

Atypical antipsychotics such as seroquel have been used successfully as adjunctive treatments in other anxiety disorders, including PTSD (Labatte, 2001; Krashin & Oates, 1999; McDougle et al., 2000; Pfanner et al., 2000; Bogetto et al., 2000) and Generalized Anxiety Disorder (Katzman et al., 2005). Responses to the blushing exposure will be assessed prior to and following treatment with seroquel or placebo and at one month following intervention. Levels of prostaglandin will be compared between groups and will also be correlated with symptom severity in the clinical groups.

The objective of this randomized, double blind flexible -dose study will be to evaluate the efficacy , safety and tolerability of seroquel SR 50mg to 800mg and placebo in outpatient subjects diagnosed with SP. The study will begin with a single week of Seroquel 50mg or placebo. Subsequently, tablets will be administered by the investigator in a flexible dose fashion during the visits. Patients will be followed up weekly (biweekly after week 6) and at the clinician's discretion. After the fist week the patients' dosage will be increased up to a maximum of 800 mg daily with expected average dose of 300mg dail. This dose will remain fixed after 8 weeks of treatment until week 16.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient has provided signed informed consent prior to any study-related procedures

  • Outpatient male or female aged 18-65 (inclusive).

  • Patients with a primary diagnosis of Social Phobia to DSM IV (300.23) criteria (diagnosis to be made using the MINI International Neuropsychiatric Interview (MINI).

  • Score of > 60 on the LSAS.

  • On the basis of a physical examination, medical history and basic laboratoryscreening, the patient is, in the investigator's opinion, in suitable condition.

Exclusion

Exclusion Criteria:

  • Pregnancy or lactation

  • Any DSM-IV Axis I disorder not defined in the inclusion criteria

  • Patients who, in the opinion of the investigator, pose an immediate risk of suicide ora danger to self or others

  • Known intolerance or lack of response to quetiapine fumarate, as judged by theinvestigator

  • Use of any of the following P450 3A4 inhibitors in the 14 days preceding enrollmentincluding but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin,clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, andsaquinavir.

  • Use of any of the following cytochrome P450 inducers in the 14 days precedingenrolment including but not limited to: phenytoin, carbamazepine, barbiturates,rifampin, St. John's Wort, and glucocorticoids.

  • Administration of a depot antipsychotic injection within one dosing interval (for thedepot) before randomization

  • Substance or alcohol dependence at enrolment (except dependence in full remission, andexcept for caffeine or nicotine dependence), as defined by the DSM-IV criteria

  • Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IVcriteria within 4 weeks prior to enrolment

  • Positive drug screen result at screening visit and if clinically relevant judged bythe investigator

  • Medical conditions that would affect absorption, distribution, metabolism, orexcretion of study treatment

  • Unstable or inadequately treated medical illnesses (e.g. diabetes, angina pectoris,hypertension) as judged by the investigator

  • Involvement in the planning or conduct of the study

  • Previous enrollment or randomization of treatment in the present study

  • Participation in another drug trail within 4 weeks prior enrollment into this study orlonger in accordance with local requirements

  • Continuation or commencement of formal psychotherapy

  • Current use of or commencement of antidepressant and anxiolytic medications

  • Patients, who have been on an antidepressant or other anxiolytic prior to the study,will have discontinues these more than two weeks prior to entry into the study. Thosewho have been on fluoxetine, will have been off for at least five weeks.

  • Patients, who have been on a herbal or alternative treatment judged to be potentiallyanxiolytic or with psychobiological activity, will have terminated usage of the agentmore than two weeks prior to entering the study

  • Previous reactions to Niacin administration

  • Use of a non-steroidal anti-inflammatory

  • Any psychotic disorder

  • Eating disorder as defined in the DSM IV

  • Mental retardation or other cognitive disorder

  • Laboratory values at screening or in medical history that may be considered throughclinical interpretation to be significant

  • Serious illness: Liver or renal insufficiency, cardiac, vascular, pulmonary,gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolicdisturbance

  • An absolute neutrophil count (ANC) of <1.5 x 109 per liter.

  • Unstable Diabetes Mellitus/HbA1c

Study Design

Total Participants: 21
Study Start date:
October 01, 2008
Estimated Completion Date:
August 31, 2013

Connect with a study center

  • START Clinic for the Mood and Anxiety Disorders

    Toronto, Ontario M4W 2N4
    Canada

    Site Not Available

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