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Trial record 25 of 450 for:    QUETIAPINE

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

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ClinicalTrials.gov Identifier: NCT01224067
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Cambridge Health Alliance

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: Quetiapine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Quetiapine
Quetiapine (dosage 50mg to 300mg + sertraline)Experimental
Drug: Quetiapine
Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.
Other Name: Seroquel

Placebo Comparator: Placebo
Participant will receive placebo for 8 weeks.
Drug: Quetiapine
Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.
Other Name: Seroquel




Primary Outcome Measures :
  1. Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Change from Baseline to Endpoint at 8 weeks ]
    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 :
  1. Clinical Global Impression of Improvement (CGI-I) scores [ Time Frame: Change from Baseline to Endpoint at 8 weeks ]
    Change from Baseline to Endpoint after 8 weeks of treatment in overall clinical improvement of social anxiety symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224067


Locations
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United States, Massachusetts
Cambridge Health Alliance
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Cambridge Health Alliance
AstraZeneca
Investigators
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Principal Investigator: Gustavo D Kinrys, MD Cambridge Health Alliance; Harvard Medical School

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Responsible Party: Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT01224067     History of Changes
Other Study ID Numbers: CHA-IRB-0094/11/04
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Quetiapine Fumarate
Disease
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs