| City: |
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Boston |
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State:
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MA |
| Zip Code: |
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02114 |
| Conditions: |
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Social Anxiety Disorder |
| Purpose: |
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The purpose of this study is to test a drug called d-cycloserine to see if it can help
people with a condition called social phobia. Social phobia is also called "social anxiety
disorder." Social phobia is a constant fear of social or performance situations. Social
situations include group gatherings of any kind. Performance situations might include
times when a person would have to do something in public, such as speak up in class or at a
meeting. A person with this condition worries about being embarrassed, or about other
people's opinions. People with social phobia usually feel extremely anxious (nervous and
worried) about being the focus of attention. They often avoid social and performance
situations. This behavior can have a negative effect on the quality of their lives and
relationships.
In this study, we want to find out if d-cycloserine can help control social phobia when the
drug is added to the standard treatment for this condition. The standard treatment is
cognitive-behavior therapy (CBT). CBT is a form of talk therapy involving discussion with a
therapist, along with practicing the feelings or events that the person finds frightening.
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| Study summary: |
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Inclusion criteria:
1. Age 18 or older
2. Primary diagnosis of SAD
3. Physical examination, electrocardiogram, and laboratory findings without clinically
significant abnormalities.
4. Willingness and ability to comply with the requirements of the study protocol.
Diagnostic Exclusion Criteria:
1. A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders
or obsessive-compulsive disorder; an eating disorder in the past 6 months; organic
brain syndrome, mental retardation or other cognitive dysfunction that could interfere
with capacity to engage in therapy; a history of substance or alcohol abuse or
dependence (other than nicotine) in the last 6 months or otherwise unable to commit to
refraining from alcohol use during the acute period of study participation.
2. Patients with posttraumatic stress disorder within the past 6 months are excluded.
Entry of patients with other mood or anxiety disorders 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.
3. Patients must be off concurrent psychotropic medication (e.g., antidepressants,
anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized
treatment.
4. Significant personality dysfunction likely to interfere with study participation.
5. Serious medical illness or instability for which hospitalization may be likely within
the next year.
6. Patients with a current or past history of seizures
7. 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).
8. Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing
psychotherapy of any duration directed specifically toward treatment of the GSAD is
excluded. Prohibited psychotherapy includes CBT or psychodynamic therapy focusing on
exploring specific, dynamic causes of the phobic symptomatology and provides management
skills. General supportive therapy initiated > 3 months prior is acceptable.
9. Prior non-response to adequately-delivered exposure (i.e., as defined by the patient's
report of receiving specific and regular exposure assignments as part of a previous
treatment) will exclude participants from the study.
10. Patients with a history of head trauma causing loss of consciousness, seizure or
ongoing cognitive impairment.
11. Patients receiving isoniazid.
12. Patients unable to understand study procedures and participate in the informed consent
process. |
| Criteria: |
|
Inclusion Criteria:
1. Male or female outpatients > 18 years of age with a primary psychiatric diagnosis
(designated by the patient as the most important source of current distress) of
generalized social anxiety disorder (GSAD) as defined by DSM-IV criteria.
2. A total score > 60 on the LSAS.
3. Physical examination, electrocardiogram, and laboratory findings without clinically
significant abnormalities.
4. Willingness and ability to comply with the requirements of the study protocol.
Exclusion Criteria:
1. A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional
disorders or obsessive-compulsive disorder; an eating disorder in the past 6 months;
organic brain syndrome, mental retardation or other cognitive dysfunction that could
interfere with capacity to engage in therapy; a history of substance or alcohol abuse
or dependence (other than nicotine) in the last 6 months or otherwise unable to
commit to refraining from alcohol use during the acute period of study participation.
2. Patients with posttraumatic stress disorder within the past 6 months are excluded.
Entry of patients with other mood or anxiety disorders 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.
3. Patients must be off concurrent psychotropic medication (e.g., antidepressants,
anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized
treatment.
4. Significant personality dysfunction likely to interfere with study participation.
5. Serious medical illness or instability for which hospitalization may be likely within
the next year.
6. Patients with a current or past history of seizures
7. 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).
8. Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing
psychotherapy of any duration directed specifically toward treatment of the GSAD is
excluded. Prohibited psychotherapy includes CBT or psychodynamic therapy focusing on
exploring specific, dynamic causes of the phobic symptomatology and provides
management skills. General supportive therapy initiated > 3 months prior is
acceptable.
9. Prior non-response to adequately-delivered exposure (i.e., as defined by the
patient's report of receiving specific and regular exposure assignments as part of a
previous treatment) will exclude participants from the study.
10. Patients with a history of head trauma causing loss of consciousness, seizure or
ongoing cognitive impairment.
11. Patients receiving isoniazid.
12. Patients unable to understand study procedures and participate in the informed
consent process. |
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| Study is available at: |
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Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital
Boston, MA 02114
United States
Primary Contact:
Mark H Pollack, MD
Email: mpollack@partners.org
Phone: 617-724-0844 |
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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 22, 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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