Social Anxiety DisorderPhase 4NCT00633984
D-Cycloserine Enhancement of Exposure in Social Phobia
A Phase 4 study testing Cognitive Behavioral Group Therapy (CBGT) and D-Cycloserine in people with Social Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Cognitive Behavioral Group Therapy (CBGT) and D-Cycloserine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Sep 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- A total score > 60 on the LSAS.
- Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities.
- Willingness and ability to comply with the requirements of the study protocol.
Who cannot join
- 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.
- 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.
- 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
Show all 12Show fewer
- 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 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.
- 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.
- Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
- Patients receiving isoniazid.
- Patients unable to understand study procedures and participate in the informed consent process.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the detailed description
Inclusion criteria:
- Age 18 or older
- Primary diagnosis of SAD
- Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities.
- Willingness and ability to comply with the requirements of the study protocol.
Diagnostic 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.
- 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.
- 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 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.
- 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.
- Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
- Patients receiving isoniazid.
- Patients unable to understand study procedures and participate in the informed consent process.
- Conditions
- Social Anxiety Disorder
- Being tested
- Cognitive Behavioral Group Therapy (CBGT), D-Cycloserine, Placebo
- Keywords
- Social Anxiety Disorder, Cognitive Behavioral Group Therapy, D-cycloserine
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Group Therapy (CBGT)Behavioural
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.
D-CycloserineDrug
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Group Therapy + D-Cycloserine | Active comparator | Participants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine. Receives: Behavioral: Cognitive Behavioral Group Therapy (CBGT); Drug: D-Cycloserine |
| Cognitive Behavioral Group Therapy + Placebo | Placebo comparator | Participants received Cognitive Behavioral Group Therapy and 50mg Placebo. Receives: Behavioral: Cognitive Behavioral Group Therapy (CBGT); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale (LSAS)
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
Measured: Week 13
CGI - Clinical Global Impression of Improvement
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.
Measured: Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startMar 2007
- Primary completionMar 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, Southern Methodist University, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mark H. Pollack, Massachusetts General Hospital
- Investigators
- Mark H Pollack, MD, Principal investigator, mpollack@partners.orgStefan Hofmann, Principal investigator, shofmann@bu.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633984
- Sponsor's protocol ID
- 2007-P-000386
- Other IDs
- R01MH075889
- Status last verified
- Apr 2014
- First submitted
- 4 Mar 2008
- Last updated
- 14 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zalta AK, Dowd S, Rosenfield D, Smits JA, Otto MW, Simon NM, Meuret AE, Marques L, Hofmann SG, Pollack MH. Sleep quality predicts treatment outcome in CBT for social anxiety disorder. Depress Anxiety. 2013 Nov;30(11):1114-20. doi: 10.1002/da.22170. Epub 2013 Aug 26.
PubMed 24038728Smits JA, Rosenfield D, Otto MW, Marques L, Davis ML, Meuret AE, Simon NM, Pollack MH, Hofmann SG. D-cycloserine enhancement of exposure therapy for social anxiety disorder depends on the success of exposure sessions. J Psychiatr Res. 2013 Oct;47(10):1455-61. doi: 10.1016/j.jpsychires.2013.06.020. Epub 2013 Jul 16.
PubMed 23870811Hofmann SG, Smits JA, Rosenfield D, Simon N, Otto MW, Meuret AE, Marques L, Fang A, Tart C, Pollack MH. D-Cycloserine as an augmentation strategy with cognitive-behavioral therapy for social anxiety disorder. Am J Psychiatry. 2013 Jul;170(7):751-8. doi: 10.1176/appi.ajp.2013.12070974.
PubMed 23599046
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-Cycloserine Enhancement of Exposure in Social Phobia
- ClinicalTrials.gov ID
- NCT00633984
- Acronym / sponsor ID
- 2007-P-000386
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Anxiety Disorder, Cognitive Behavioral Group Therapy, D-cycloserine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston University, Southern Methodist University, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- Mar 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Posted 14 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Age 18 or older
- Primary diagnosis of SAD
- Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities.
- Willingness and ability to comply with the requirements of the study protocol.
Diagnostic 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.
- 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.
- 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 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.
- 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.
- Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
- Patients receiving isoniazid.
- Patients unable to understand study procedures and participate in the informed consent process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Group Therapy + D-Cycloserine | Active comparator | Behavioral: Cognitive Behavioral Group Therapy (CBGT), Drug: D-CycloserineParticipants received Cognitive Behavioral Group Therapy and 50mg D-Cycloserine. |
| Cognitive Behavioral Group Therapy + Placebo | Placebo comparator | Behavioral: Cognitive Behavioral Group Therapy (CBGT), Drug: PlaceboParticipants received Cognitive Behavioral Group Therapy and 50mg Placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- A total score > 60 on the LSAS.
- Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities.
- Willingness and ability to comply with the requirements of the study protocol.
Key exclusion criteria (12 listed)
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive Behavioral Group Therapy + D-Cycloserine, Cognitive Behavioral Group Therapy + Placebo |
| D-CycloserineFor 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 | Cognitive Behavioral Group Therapy + D-Cycloserine |
| PlaceboFor 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. | Drug | Cognitive Behavioral Group Therapy + Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24038728Zalta AK, Dowd S, Rosenfield D, Smits JA, Otto MW, Simon NM, Meuret AE, Marques L, Hofmann SG, Pollack MH. Sleep quality predicts treatment outcome in CBT for social anxiety disorder. Depress Anxiety. 2013 Nov;30(11):1114-20. doi: 10.1002/da.22170. Epub 2013 Aug 26.
- Derived from this study: PubMed 23870811Smits JA, Rosenfield D, Otto MW, Marques L, Davis ML, Meuret AE, Simon NM, Pollack MH, Hofmann SG. D-cycloserine enhancement of exposure therapy for social anxiety disorder depends on the success of exposure sessions. J Psychiatr Res. 2013 Oct;47(10):1455-61. doi: 10.1016/j.jpsychires.2013.06.020. Epub 2013 Jul 16.
- Derived from this study: PubMed 23599046Hofmann SG, Smits JA, Rosenfield D, Simon N, Otto MW, Meuret AE, Marques L, Fang A, Tart C, Pollack MH. D-Cycloserine as an augmentation strategy with cognitive-behavioral therapy for social anxiety disorder. Am J Psychiatry. 2013 Jul;170(7):751-8. doi: 10.1176/appi.ajp.2013.12070974.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark H Pollack, MD principal investigator
mpollack@partners.org
Stefan Hofmann principal investigator
shofmann@bu.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive Behavioral Group Therapy (CBGT) and D-Cycloserine in people with Social Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liebowitz Social Anxiety Scale (LSAS) (time frame: Week 13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00633984, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.