Dose Timing of D-Cycloserine to Augment CBT for Social Anxiety Disorder

Inclusion Criteria:

- 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 social
anxiety disorder as defined by DSM-5 criteria.

- A total score > 60 on the LSAS.

- Physical examination and laboratory findings without clinically significant
abnormalities.

- Willingness and ability to participate in the informed consent process and comply with
the requirements of the study protocol.

Exclusion Criteria:

- 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.

- PTSD within the past 6 months. Entry of patients with other mood or anxiety disorders
will be permitted if the SAD 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.

- Patients must be off concurrent psychotropic medication (e.g., antidepressants,
anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized
treatment.

- Significant personality dysfunction likely to interfere with study participation.

- Serious medical illness or instability for which hospitalization may be likely within
the next year.

- Patients with a current or past history of seizures.

- 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).

- Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing
psychotherapy of any duration directed specifically toward treatment of the SAD is
excluded. Prohibited psychotherapy includes CBT or psychodynamic therapy focusing on
exploring specific, dynamic causes of the phobic symptomatology and providing
management skills. General supportive therapy initiated > 3 months prior is
acceptable.

- 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).

- Patients with a history of head trauma causing loss of consciousness, seizure or
ongoing cognitive impairment. Current use of isoniazid or ethionamide compounds

- Insufficient command of the English language