Flushing in Social Anxiety Disorder on Seroquel

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Dr. Martin A. Katzman, START Clinic for Mood and Anxiety Disorders
ClinicalTrials.gov Identifier:
NCT00773162
First received: October 15, 2008
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Social Anxiety Disorder
Drug: Seroquel
Drug: Sugar Pill
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Single-center, Randomized, Double-blind, Phase III Comparison of the Efficacy and Safety of Quetiapine Fumarate (Oral Extended Release Tablets) to Placebo in Social Phobia Patients and Changes in Their Vasodilatory Response to Methyl-Nicotinate

Resource links provided by NLM:


Further study details as provided by START Clinic for Mood and Anxiety Disorders:

Primary Outcome Measures:
  • Changes in intensity of the vasodilatory response to 10 mM topical m-N over 16 weeks. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline on the HAM-A, CGI, SF-36, LSAS, SPIN, SIAS, SPS, ASI, BAI, BDI, SHEEHAN, EUROQUEL, BIS/BAS, PSWQ, IUS [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: October 2008
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Sugar Pill
Sugar pill to match seroquel
Active Comparator: 2 Drug: Seroquel
seroquel XR- oral extended release tablets, 50mg - 300mg, 16 weeks
Other Name: Quetiapine

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 laboratory screening, the patient is, in the investigator's opinion, in suitable condition.

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 or a danger to self or others
  • Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
  • Use of any of the following P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine, and saquinavir.
  • Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment 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 the depot) before randomization
  • Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by the DSM-IV criteria
  • Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
  • Positive drug screen result at screening visit and if clinically relevant judged by the investigator
  • Medical conditions that would affect absorption, distribution, metabolism, or excretion 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 or longer 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. Those who 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 potentially anxiolytic or with psychobiological activity, will have terminated usage of the agent more 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 through clinical interpretation to be significant
  • Serious illness: Liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolic disturbance
  • An absolute neutrophil count (ANC) of <1.5 x 109 per liter.
  • Unstable Diabetes Mellitus/HbA1c
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773162

Locations
Canada, Ontario
START Clinic for the Mood and Anxiety Disorders
Toronto, Ontario, Canada, M4W 2N4
Sponsors and Collaborators
START Clinic for Mood and Anxiety Disorders
AstraZeneca
Investigators
Principal Investigator: Martin A Katzman, MD START Clinic for Mood and Anxiety Disorders
  More Information

No publications provided

Responsible Party: Dr. Martin A. Katzman, Principal Investigator, START Clinic for Mood and Anxiety Disorders
ClinicalTrials.gov Identifier: NCT00773162     History of Changes
Other Study ID Numbers: AzSeroSP
Study First Received: October 15, 2008
Last Updated: February 24, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 01, 2014