Anxiety DisorderPhase 3NCT00114127
Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome
A Phase 3 study testing Duloxetine in people with Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine the safety and efficacy of duloxetine for the treatment of social anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorder
- What is being tested?
- Duloxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jul 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to examine the safety and efficacy of duloxetine for the treatment of social anxiety disorder.
Read the 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).
- Conditions
- Anxiety Disorder
- Being tested
- Duloxetine, Placebo
- Keywords
- social anxiety disorder, social phobia, duloxetine, serotonin norepinephrine reuptake inhibitor, SNRI, double blind
- Medical subject headings
- Anxiety Disorders, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
60 mg duloxetine 1x per day
DuloxetineDrug
Also called Cymbalta
60 mg duloxetine 1x per day + 60mg duloxetine 1x per day
PlaceboDrug
60mg placebo 1x per day
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine 60mg + Placebo for 18 Weeks | Placebo comparator | In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine. Receives: Drug: Duloxetine; Drug: Placebo |
| Duloxetine 120mg for 18 Weeks | Active comparator | In Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine. Receives: Drug: Duloxetine |
| Duloxetine 60mg/day for 6 Weeks | Active comparator | In Phase 1 all participants entered an open trial. Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
CGI-S
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2005 (estimated)
- Study startJun 2004
- Primary completionNov 2008
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi M. Simon, Massachusetts General Hospital
- Investigators
- Naomi M Simon, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114127
- Sponsor's protocol ID
- 2004-P-001384
- Status last verified
- Jun 2014
- First submitted
- 13 Jun 2005
- Last updated
- 10 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome
- ClinicalTrials.gov ID
- NCT00114127
- Acronym / sponsor ID
- 2004-P-001384
- Conditions
- Anxiety Disorder
- Keywords
- social anxiety disorder, social phobia, duloxetine, serotonin norepinephrine reuptake inhibitor, SNRI, double blind
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Jun 2005 (estimated)
- Results
- Posted 7 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the safety and efficacy of duloxetine for the treatment of social anxiety disorder.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Duloxetine 60mg + Placebo for 18 Weeks | Placebo comparator | Drug: Duloxetine, Drug: PlaceboIn Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine. |
| Duloxetine 120mg for 18 Weeks | Active comparator | Drug: DuloxetineIn Phase 2 participants were randomized to 60mg Duloxetine + Placebo or 120mg Duloxetine. |
| Duloxetine 60mg/day for 6 Weeks | Active comparator | Drug: DuloxetineIn Phase 1 all participants entered an open trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: Cymbalta60 mg duloxetine 1x per day | Drug | Duloxetine 60mg + Placebo for 18 Weeks, Duloxetine 60mg/day for 6 Weeks |
| DuloxetineAlso: Cymbalta60 mg duloxetine 1x per day + 60mg duloxetine 1x per day | Drug | Duloxetine 120mg for 18 Weeks |
| Placebo60mg placebo 1x per day | Drug | Duloxetine 60mg + Placebo for 18 Weeks |
Primary outcome
Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale
Time frame: 6 months
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.
1 secondary outcome
CGI-S
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Official Website for the Center for Anxiety and Traumatic Stress DisordersLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi M Simon, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duloxetine in people with Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2014.