Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00114127
First received: June 13, 2005
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to examine the safety and efficacy of duloxetine for the treatment of social anxiety disorder.


Condition Intervention Phase
Anxiety Disorder
Drug: Duloxetine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations with higher scores representing increased social anxiety. The LSAS contains three total scores: 1) total fear score (0-72), 2) total avoidance score(0-72), 3) and total overall score (0-144). Suggested interpretations: 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia.


Secondary Outcome Measures:
  • CGI-S [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    The Clinician Global Impression-Severity Scale (CGI-S) is a clinician-rated instrument used to assess global severity of symptoms (Guy, 1976). The CGI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

    Baseline collected for Phase 1 at week 0 and for Phase 2 at week 6.



Enrollment: 28
Study Start Date: June 2004
Study Completion Date: July 2010
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Duloxetine 60mg + Placebo for 18 Weeks
In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine.
Drug: Duloxetine
60 mg duloxetine 1x per day
Other Name: Cymbalta
Drug: Placebo
60mg placebo 1x per day
Active Comparator: Duloxetine 120mg for 18 Weeks
In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine.
Drug: Duloxetine
60 mg duloxetine 1x per day + 60mg duloxetine 1x per day
Other Name: Cymbalta
Active Comparator: Duloxetine 60mg/day for 6 Weeks
In Phase 1 all participants entered an open trial.
Drug: Duloxetine
60 mg duloxetine 1x per day
Other Name: Cymbalta

Detailed Description:

An expanding body of clinical experience and controlled trials has established the efficacy of serotonin selective reuptake inhibitors (SSRIs) and the serotonin norepinephrine reuptake inhibitor (SNRI) venlafaxine, for the treatment of social anxiety disorder, with paroxetine, sertraline and venlafaxine extended-release (XR), which are FDA approved for this indication. The newest SNRI, duloxetine, has been shown to be effective at doses of 60mg/day to 120mg/day for anxiety associated with depression, and is anticipated to be a broad spectrum agent for mood and anxiety disorders (Dunner, Goldstein, Mallinckrodt, Lu, & Detke, 2003). However, no data on the efficacy of duloxetine for Social Anxiety Disorder, nor guidance regarding time to response or predictors of response, is yet available. These questions are the focus of this proposal.

This is a two phase, 24-week research study in which participants who remain symptomatic at the end of one phase (6 weeks) enter into the next phase. In phase I, all participants receive 60mg/day of duloxetine (Cymbalta) for 6 weeks. Participants who continue to have anxiety symptoms will enter the 18-week Phase II, in which they continue taking 60 mg/day of duloxetine and they will also be randomly assigned (by chance, like a flip of a coin) to receive either an additional 60mg/day of duloxetine or placebo (contains no active medication).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female outpatients > 18 years of age with a primary psychiatric diagnosis of generalized social anxiety disorder as defined by DSM-IV criteria and an LSAS score > 50.
  • Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities.
  • Willingness and ability to comply with the requirements of the study protocol.

Exclusion Criteria:

  • Patient has a history of intolerance or lack of response to a treatment trial of duloxetine at highest tolerated dose (<120mg/day).
  • Patients with acute narrow angle glaucoma.
  • Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).
  • Concurrent use of other psychotropic medications. Patients must discontinue regular benzodiazepine or antidepressant therapy at least one week (5 weeks for fluoxetine) prior to baseline. Concomitant beta-blockers are proscribed unless prescribed for a medical indication (e.g., hypertension, at a stable daily dose for > 1 month).
  • Patients with a history of failure to satisfactorily respond to >2 prior adequate treatment trials.
  • Significant personality dysfunction likely to interfere with study participation.
  • Serious medical illness or instability for which hospitalization may be likely within the next year.
  • Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood, were isolated, and did not recur in adulthood.
  • Concurrent psychotherapy initiated within 2 months of baseline is prohibited. Ongoing psychotherapy of any duration directed specifically toward treatment of the social anxiety disorder is excluded. Prohibited psychotherapy includes cognitive behavioral therapy or psychodynamic therapy that focuses on exploring specific, dynamic causes of the phobic symptomatology and provides skills for their management. General supportive individual, couples, or family therapy greater than 2 months duration is acceptable.
  • Diagnosis of any of the following mental disorders as defined by the DSM-IV: a lifetime history of schizophrenia or any other psychosis, mental retardation, organic medical disorders or bipolar disorder; eating disorders in the past 6 months; alcohol or substance abuse in the past 3 months or dependence within the past 6 months.
  • Entry of patients with major depression, dysthymia, panic disorder, generalized anxiety disorder, post-traumatic stress disorder or obsessive-compulsive disorder will be permitted if the social anxiety disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample.
  • Patients with significant suicidal ideation (MADRS item 10 score > 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114127

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Naomi M Simon, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Naomi M. Simon, Director, Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00114127     History of Changes
Other Study ID Numbers: 2004-P-001384
Study First Received: June 13, 2005
Results First Received: January 27, 2012
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
social anxiety disorder
social phobia
duloxetine
serotonin norepinephrine reuptake inhibitor
SNRI
double blind

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014