D-Cycloserine Enhancement of Exposure in Social Phobia
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: Cognitive Behavioral Group Therapy (CBGT); D-Cycloserine; Placebo
Intervention description: The patient will then receive 12 weekly sessions of Cognitive Behavioral Therapy lasting approximately two and a half hours each. During these sessions, patients will receive information on the nature of social phobia and a model of treatment and will receive weekly training in how to become more comfortable with social situations, with the goal of achieving confidence in social interactions. As part of this training, the therapist will practice social interactions with the patient, who will also be asked to practice what they have learned outside of the therapists' office.; For the third, fourth, fifth, sixth, and seventh sessions of the twelve-session program of Cognitive Behavioral Therapy, the patient will be asked to arrive one hour early to take one of the study pill, a 50mg pill of d-cycloserine. A physician will be available in the unlikely event that a patient begins to experience side effects. Before the treatment starts, before the eighth session, and one week after the final session patients will have a separate visit in which their levels of symptoms assessed with measures of mood, anxiety, and avoidance.; For the third, fourth, fifth, sixth, and seventh sessions of the twelve-session program of Cognitive Behavioral Therapy, the patient will be asked to arrive one hour early to take one of the study pill, a placebo. A physician will be available in the unlikely event that a patient begins to experience side effects. Before the treatment starts, before the eighth session, and one week after the final session patients will have a separate visit in which their levels of symptoms assessed with measures of mood, anxiety, and avoidance.
Intervention MeSH terms: Cycloserine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Social Anxiety Disorder; Cognitive Behavioral Group Therapy; D-cycloserine

Summary:

      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.
    

Eligibility 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.