Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome

NCT00114127 | Completed Phase 3 Results

• 1 other identifier: 2004-P-001384
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety Disorder

Keywords

social anxiety disorder; social phobia; duloxetine; serotonin norepinephrine reuptake inhibitor; SNRI; double blind

Outcome Measures

Primary Outcomes (1)

• Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale

  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.

  6 months

Secondary Outcomes (1)

• CGI-S

  6 months

Study Arms (3)

Duloxetine 60mg + Placebo for 18 Weeks

PLACEBO COMPARATOR

In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine.

Drug: Duloxetine; Drug: Placebo

Duloxetine 120mg for 18 Weeks

ACTIVE COMPARATOR

In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine.

Drug: Duloxetine

Duloxetine 60mg/day for 6 Weeks

ACTIVE COMPARATOR

In Phase 1 all participants entered an open trial.

Drug: Duloxetine

Interventions

Duloxetine DRUG

60 mg duloxetine 1x per day

Also known as: Cymbalta

Duloxetine 60mg + Placebo for 18 Weeks; Duloxetine 60mg/day for 6 Weeks

Placebo DRUG

60mg placebo 1x per day

Duloxetine 60mg + Placebo for 18 Weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• Official Website for the Center for Anxiety and Traumatic Stress Disorders

MeSH Terms

Conditions

Anxiety Disorders; Phobia, Social

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Open-label in phase Phase 1; Limited power due to small sample size.

Results Point of Contact

• Title: Dr. Naomi Simon
• Organization: Massachusetts General Hospital

nsimon@partners.org

617-726-7913

Study Officials

• Naomi M Simon, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Anxiety and Traumatic Stress Disorders

Study Record Dates

• First Submitted: June 13, 2005
• First Posted: June 14, 2005
• Study Start: June 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: July 1, 2010
• Last Updated: June 10, 2014
• Results First Posted: June 7, 2012

Record last verified: 2014-06

Locations

US (1)