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Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults

Primary Purpose

Social Anxiety Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Quetiapine

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female outpatients, age 18-65.
Diagnosis of Social Anxiety Disorder (SAD), generalized subtype, by DSM-IV criteria.
Liebowitz Social Anxiety Scale (LSAS) rating greater than or equal to 50 for both phases.
Hamilton Depression Scale (HAM-D-17) score less than or equal to 16.

Exclusion Criteria:

Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months).
Patients with current or history of bipolar disorder, schizophrenia, or other psychotic conditions.
Patients with a history of alcohol or substance abuse or dependence within the last six months or a positive toxicology screen consistent with abuse at baseline.
Patients with significant unstable medical illness, including any medical pathology considered not well-controlled with conventional treatment, i.e., that may require during the study period medication adjustment, ongoing tests or procedures, intensive treatment or hospitalization. In addition, baseline laboratory tests will be conducted and required to be within normal limits or have no clinical significance for patient entry in the study.
Severe personality disorders likely to interfere with study participation or who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk.
Ongoing psychotherapy directed toward the treatment of social anxiety disorder.
History of hypersensitivity to sertraline and quetiapine.

Sites / Locations

Cambridge Health Alliance

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Quetiapine

Placebo

Arm Description

Quetiapine (dosage 50mg to 300mg + sertraline)Experimental

Participant will receive placebo for 8 weeks.

Outcomes

Primary Outcome Measures

Liebowitz Social Anxiety Scale (LSAS)

Change from Baseline to Endpoint of social anxiety symptoms after 8 weeks of treatment. Assessed weekly throughout the study for a total of 8 weeks.

Secondary Outcome Measures

Clinical Global Impression of Improvement (CGI-I) scores

Change from Baseline to Endpoint after 8 weeks of treatment in overall clinical improvement of social anxiety symptoms.

Full Information

NCT ID

NCT01224067

First Posted

September 10, 2010

Last Updated

April 17, 2017

Sponsor

Cambridge Health Alliance

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01224067

Brief Title

Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults

Official Title

A Double-Blind, Placebo-Controlled, Flexible-Dosage Study to Evaluate the Efficacy and Safety of Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cambridge Health Alliance

Collaborators

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a 16-week research study in which participants suffering from Social Anxiety Disorder (SAD) will receive Sertraline (a medication FDA approved for the treatment of SAD) for the first 8 weeks. If a participant remains symptomatic, he/she will enter the second phase of the study in which he/she continues taking Sertraline but also randomly receives either Seroquel or placebo in conjunction with Sertraline for additional 8 weeks. The purpose of this study is to determine the efficacy of adjunctive Seroquel in treating SAD.

Detailed Description

This will be a single-site study aimed at evaluating the safety, tolerability, and efficacy of quetiapine as compared to placebo in the treatment of generalized anxiety disorder. This will be an 8-week open-label sertraline trial followed by a randomized double-blind placebo-controlled, parallel-group prospective study. Participants will first receive sertraline (25-200 mg/day) for 8 weeks. Patients who remain symptomatic - are considered refractory - and meet inclusion criteria will be randomized and enter the double-blind phase. They will receive either adjunctive quetiapine (25-400 mg/day) or placebo for 8 weeks. The primary outcome measures are change in the Liebowitz Social Anxiety Scale(LSAS) and Clinical Global Impression of Improvement (CGI-I) scores. The proposed sample size is 80 subjects. Patients will be discontinued from the study if needed due to ineffectiveness or excessive side effects. Measurements of changes in efficacy and side effects will be carried out every weekly visit. Enrollment will occur over 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Social Anxiety Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Quetiapine

Arm Type

Active Comparator

Arm Description

Quetiapine (dosage 50mg to 300mg + sertraline)Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participant will receive placebo for 8 weeks.

Intervention Type

Drug

Intervention Name(s)

Quetiapine

Other Intervention Name(s)

Seroquel

Intervention Description

Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.

Primary Outcome Measure Information:

Title

Liebowitz Social Anxiety Scale (LSAS)

Description

Change from Baseline to Endpoint of social anxiety symptoms after 8 weeks of treatment. Assessed weekly throughout the study for a total of 8 weeks.

Time Frame

Change from Baseline to Endpoint at 8 weeks

Secondary Outcome Measure Information:

Title

Clinical Global Impression of Improvement (CGI-I) scores

Description

Change from Baseline to Endpoint after 8 weeks of treatment in overall clinical improvement of social anxiety symptoms.

Time Frame

Change from Baseline to Endpoint at 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female outpatients, age 18-65. Diagnosis of Social Anxiety Disorder (SAD), generalized subtype, by DSM-IV criteria. Liebowitz Social Anxiety Scale (LSAS) rating greater than or equal to 50 for both phases. Hamilton Depression Scale (HAM-D-17) score less than or equal to 16. Exclusion Criteria: Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months). Patients with current or history of bipolar disorder, schizophrenia, or other psychotic conditions. Patients with a history of alcohol or substance abuse or dependence within the last six months or a positive toxicology screen consistent with abuse at baseline. Patients with significant unstable medical illness, including any medical pathology considered not well-controlled with conventional treatment, i.e., that may require during the study period medication adjustment, ongoing tests or procedures, intensive treatment or hospitalization. In addition, baseline laboratory tests will be conducted and required to be within normal limits or have no clinical significance for patient entry in the study. Severe personality disorders likely to interfere with study participation or who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk. Ongoing psychotherapy directed toward the treatment of social anxiety disorder. History of hypersensitivity to sertraline and quetiapine.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gustavo D Kinrys, MD

Organizational Affiliation

Cambridge Health Alliance; Harvard Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cambridge Health Alliance

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02139

Country

United States

12. IPD Sharing Statement

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Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults

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