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D-Cycloserine Enhancement of Exposure in Social Phobia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00633984
Recruitment Status : Completed
First Posted : March 12, 2008
Results First Posted : May 14, 2014
Last Update Posted : May 14, 2014
Sponsor:
Collaborators:
Boston University
Southern Methodist University
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mark H. Pollack, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE March 4, 2008
First Posted Date  ICMJE March 12, 2008
Results First Submitted Date  ICMJE January 2, 2014
Results First Posted Date  ICMJE May 14, 2014
Last Update Posted Date May 14, 2014
Study Start Date  ICMJE March 2007
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2014)
  • Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Week 13 ]
    The Liebowitz Social Anxiety Scale (LSAS) is a 24-item measure designed to assess both fear and avoidance of social and performance situations occurring in the last week. Each item is rated from 0-3 for both fear and avoidance with a possible score of 144; 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, and Greater than 95 - Very severe social phobia. Remission was defined as a score of < 30 on the Liebowitz Social Anxiety Scale
  • CGI - Clinical Global Impression of Improvement [ Time Frame: Week 13 ]
    The Clinician Global Impression-Improvement Scale (CGI-I) is a clinician-rated instrument used to assess global severity of symptoms. The CGI-I ranges from 1 ("very much improved") to 7 ("very much worse"). Response and remission was defined as an improvement score of 1 ("very much improved") or 2 ("much improved") on the CGI-I.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2008)
Leibowitz Social Anxiety Scale (LSAS) [ Time Frame: Screen; Baseline; Weeks 2, 3, 4, 5, 6, 7, 8, 10, and 12; 1-, 3-, and 6-month followup ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE D-Cycloserine Enhancement of Exposure in Social Phobia
Official Title  ICMJE D-Cycloserine Enhancement of Exposure in Social Phobia
Brief 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.

Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Social Anxiety Disorder
Intervention  ICMJE
  • Behavioral: Cognitive Behavioral Group Therapy (CBGT)
    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.
  • Drug: D-Cycloserine
    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.
  • Drug: Placebo
    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.
Study Arms  ICMJE
  • Active Comparator: Cognitive Behavioral Group Therapy + D-Cycloserine
    Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine.
    Interventions:
    • Behavioral: Cognitive Behavioral Group Therapy (CBGT)
    • Drug: D-Cycloserine
  • Placebo Comparator: Cognitive Behavioral Group Therapy + Placebo
    Participants received Cognitive Behavioral Group Therapy and 50mg Placebo.
    Interventions:
    • Behavioral: Cognitive Behavioral Group Therapy (CBGT)
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2012)
169
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2008)
252
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00633984
Other Study ID Numbers  ICMJE 2007-P-000386
R01MH075889 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark H. Pollack, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • Boston University
  • Southern Methodist University
  • National Institutes of Health (NIH)
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Mark H Pollack, MD mpollack@partners.org
Principal Investigator: Stefan Hofmann shofmann@bu.edu
PRS Account Massachusetts General Hospital
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP