| City: |
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La Jolla |
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State:
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CA |
| Zip Code: |
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92093 |
| Conditions: |
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Social Phobia |
| Purpose: |
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This study will compare the effectiveness of either adding clonazepam or placebo to standard
treatment or switching to venlafaxine in treating generalized social anxiety disorder in
individuals who have not responded to treatment with sertraline.
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| Study summary: |
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Generalized social anxiety disorder (GSAD) is one of the most common psychiatric disorders,
and often causes significant distress and dysfunction in affected individuals. Although
currently available treatments for GSAD are effective, most individuals have residual
symptoms after initial psychosocial or psychopharmacologic intervention. Further treatment
is necessary for such individuals, but sufficient research has not been done to guide
clinicians on what the safest and most effective next step may be. This study will compare
the effectiveness of either combining clonazepam or placebo with sertraline or completely
switching to venlafaxine in treating GSAD in individuals who have not responded to treatment
with sertraline. This study will also examine predictors of treatment response, including
factors such as age at disease onset, duration of illness, comorbidities, and genes that
influence serotonin and catecholamine metabolism.
Participants in this double-blind study will first partake in an initial 10-week phase in
which they will be treated with sertraline. Participants who do not respond to sertraline
treatment will proceed to phase two of the study, in which they will be randomly assigned to
one of three treatment groups. One group will receive both sertraline and clonazepam,
another group will receive both sertraline and placebo, and the third group will receive
only venlafaxine. All treatments will continue for 12 weeks. Sertraline and venlafaxine are
both FDA-approved for the treatment of GSAD. Clonazepam is widely used for the treatment of
anxiety, but is not FDA-approved for the treatment of GSAD. All participants will attend
weekly study visits at Weeks 1, 2, 4, 6, 8, and 10. Participants who continue into phase two
will attend weekly study visits at Weeks 11-14, 16, 18, 20, and 22. Symptom remission rates
and post-treatment social phobia severity will be assessed at Week 22. |
| Criteria: |
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Inclusion Criteria:
- Primary psychiatric diagnosis of GSAD as defined by DSM-IV criteria and a score above
60 on the LSAS
- Agrees to use an effective form of contraception throughout the study
Exclusion Criteria:
- Clinically significant abnormalities found upon physical examination,
electrocardiogram, and laboratory tests
- History of more than two unsuccessful, adequate treatment trials, indicated by a lack
of response to over 10 weeks of any of the following: SSRIs (e.g., 40 mg of
paroxetine or its equivalent per day); benzodiazepine (e.g. at least 2.5 mg of
clonazepam per day) plus antidepressant (adequate dose as above); monoamine oxidase
inhibitors (e.g., 60 mg of phenelzine or its equivalent per day); or a single failed
trial of over 10 weeks of venlafaxine ( at least 150 mg per day)
- Pregnant or breastfeeding
- Simultaneous use of other psychotropic medications, with the exception of
psychostimulants to treat ADHD; participants must discontinue regular benzodiazepine
or antidepressant therapy at least two weeks (5 weeks for fluoxetine) prior to study
entry; beta-blockers must be discontinued unless they are indicated medically (e.g.,
for hypertension)
- DSM-IV diagnosis of any of the following: lifetime history of schizophrenia or any
other psychosis, mental retardation, organic medical disorder, bipolar disorder, or
obsessive compulsive disorder; eating disorder in the past 6 months; alcohol or
substance abuse in the past 3 months or dependence within the past 6 months (entry of
participants with major depression, dysthymia, panic disorder, generalized anxiety
disorder, or post-traumatic stress disorder will be permitted if the social anxiety
disorder is judged to be the predominant disorder)
- Significant suicidal ideation as indicated by a score greater than 3 on the
Montgomery-Asberg Depression Rating Scale or suicidal behaviors within 6 months prior
to study entry
- Significant personality dysfunction that could interfere with study participation
- Serious medical illness or instability for which hospitalization may be likely during
the study
- Seizure disorders, with the exception of a childhood history of isolated,
non-recurrent febrile seizures
- Any concurrent psychotherapy initiated within 3 months of study entry, or ongoing
psychotherapy of any duration directed specifically toward treatment of GSAD
(prohibited psychotherapy includes cognitive behavioral therapy or psychodynamic
therapy that focuses on exploring specific, dynamic causes of the phobic
symptomatology and that provides management skills; general supportive therapy for
more than 3 months is acceptable) |
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| Study is available at: |
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University of California San Diego
La Jolla, CA 92093
United States
Primary Contact:
Murray B. Stein, MD, MPH
Email: mstein@UCSD.Edu
Phone: 858-534-6400
Secondary Contact:
Eliora Porter, BA
Email: eporter1@partners.org
Phone: 617-726-1570 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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