Trial · NCT00515879
Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia
NCT00515879, Phase 3, Completed, Boston University Charles River Campus; results first posted 2015-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia. Trials, record NCT00515879. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00515879
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia
- NCT number
- NCT00515879
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 169 participants, actual
- Lead sponsor
- Boston University Charles River Campus
- Conditions
- Social Anxiety Disorder
- Interventions
- D-cycloserine, Cognitive behavioral therapy (CBT), Placebo
- First posted
- 2007-08-14
- Last updated
- 2019-02-26
- Results first posted
- 2015-07-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Social Phobic Disorders Severity and Change Form | Measured at Months 3 (immediately after treatment) | Social Phobic Disorders Severity and Change Form (SPD-SC Form; Liebowitz et al., 1992) is an expansion and adaptation of the Clinical Global Impression Scale (CGI) by Guy (1976) to SAD. Similar to the original CGI scale, the SPD-SC Form is rated by an independent evaluator on a 7-point scale to indicate severity (1=normal/not ill; 2 = minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most severely ill) and improvement (1=very much improved; 2=much improved; . 3=minimally improved' 4 = no change; 5=nimimal deterioration; 6=severe deterioration; 7=very severe deterioration). The primary outcome measure is units of a scale ranging from 1 (very much improved) to 7 (very severe deterioration). |
| Primary | Liebowitz Social Anxiety Scale (LSAS) | Measured at Months 3 | The Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) is a 24-item scale that provides separate scores for fear and avoidance in social and performance situations; it is widely used in treatment studies of SAD. Total scores range from 0 (no anxiety) to 144 (maximum). |
| Secondary | Social Phobia and Anxiety Inventory | Measured at Months 3, 6, and 9 post-treatment | The Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, and Stanley, 1989) is a 45-item self-report measure on the frequency (0 = Never, 1 = Very Infrequent, 2 = Infrequent, 3 = Sometimes, 4 = Frequent, 5 = Very Frequent, 6 = Always) of one's experiences. The inventory includes 32 items assessing somatic, cognitive, and behavioral symptoms of social anxiety and 13 items assessing agoraphobia. The final score is calculated by subtracting the agoraphobia subscale total (max = 78; min = 0) from the social phobia subscale total (max = 192; min = 0). Thus, the final total scores range from 0-114, where higher final scores indicate higher social anxiety. |
| Secondary | Quality of Life Enjoyment and Satisfaction Questionnaire | Measured at Months 3, 6, and 9 post-treatment | The Quality of Life Enjoyment and Satisfaction Questionnaire (Endicott et al., 1993) is a 16-item self-report measure that rates aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. Responses are scored on a 5 point scale. The maximum score is 70 (high satisfaction) and the minimum is 14 (low satisfaction); scores are generally expressed as a percentage of maximum total score (0-100). |
| Secondary | Liebowitz Self-Rated Disability Scale | Measured at Months 3, 6, and 9 post-treatment | Liebowitz Self-Rated Disability Scale (Schneier et al., 1994) is an 11-item scale assessing impairment specific to social anxiety. Current (past 2 weeks) and most severe lifetime impairment due to social anxiety disorder are rated on a 0-3 scale of degree of limitation (0=problem does not limit me at all; 3=problem limits me severely). The maximum score is 44 (severe impairment) and the minimum is 0 (no impairment). |
| Secondary | Range of Impaired Functioning Tool | Measured at Months 3, 6, and 9 post-treatment | The Range of Impaired Functioning Tool (LIFE-RIFT, Leon et al., 2000) is a clinician rated scale assessing functioning in four domains: work, interpersonal relationships, recreation, and global satisfaction. Each domain is scored 0-5 (0=not applicable, 1=no impairment, 2=slight impairment, 3=mild impairment, 4=moderate impairment, 5=severe impairment). The total score is the sum of each domain's score, with a maximum score of 20 (severe impairment) and a minimum score of 4 (no impairment). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Social Phobic Disorders Severity and Change Form | Measured at Months 3 (immediately after treatment) | Units on a scale | MEAN | |
| PRIMARY | Liebowitz Social Anxiety Scale (LSAS) | Measured at Months 3 | LSAS scores | MEAN | |
| SECONDARY | Social Phobia and Anxiety Inventory | Measured at Months 3, 6, and 9 post-treatment | The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points. | score on a scale | MEAN |
| SECONDARY | Quality of Life Enjoyment and Satisfaction Questionnaire | Measured at Months 3, 6, and 9 post-treatment | The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points. | percentage of maximum | MEAN |
| SECONDARY | Liebowitz Self-Rated Disability Scale | Measured at Months 3, 6, and 9 post-treatment | The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points. | score on a scale | MEAN |
| SECONDARY | Range of Impaired Functioning Tool | Measured at Months 3, 6, and 9 post-treatment | The number of analyzed participants differs from the overall number analyzed due to participant dropout between treatment and subsequent follow up time points. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Social Phobic Disorders Severity and Change Form | D-cycloserine-augmented CBT | 2.68 | 95% Confidence Interval 2.38 to 2.98 | Units on a scale | |
| Social Phobic Disorders Severity and Change Form | Placebo-augmented CBT | 2.95 | 95% Confidence Interval 2.64 to 3.27 | Units on a scale | |
| Liebowitz Social Anxiety Scale (LSAS) | D-cycloserine-augmented CBT | 39.19 | 95% Confidence Interval 34.79 to 43.59 | LSAS scores | |
| Liebowitz Social Anxiety Scale (LSAS) | Placebo-augmented CBT | 42.44 | 95% Confidence Interval 37.94 to 47.03 | LSAS scores | |
| Social Phobia and Anxiety Inventory | D-cycloserine-augmented CBT | 3 Months | 71.08 | Standard Deviation 28.585 | score on a scale |
| Social Phobia and Anxiety Inventory | Placebo-augmented CBT | 3 Months | 73.74 | Standard Deviation 30.311 | score on a scale |
| Social Phobia and Anxiety Inventory | D-cycloserine-augmented CBT | 6 Months | 69.64 | Standard Deviation 32.188 | score on a scale |
| Social Phobia and Anxiety Inventory | Placebo-augmented CBT | 6 Months | 71.97 | Standard Deviation 30.566 | score on a scale |
| Social Phobia and Anxiety Inventory | D-cycloserine-augmented CBT | 9 Months | 67.67 | Standard Deviation 31.847 | score on a scale |
| Social Phobia and Anxiety Inventory | Placebo-augmented CBT | 9 Months | 67.74 | Standard Deviation 33.289 | score on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | D-cycloserine-augmented CBT | 87 | |
| Overall Study | STARTED | Placebo-augmented CBT | 82 | |
| Overall Study | COMPLETED | D-cycloserine-augmented CBT | 62 | |
| Overall Study | COMPLETED | Placebo-augmented CBT | 62 | |
| Overall Study | NOT COMPLETED | D-cycloserine-augmented CBT | 25 | |
| Overall Study | NOT COMPLETED | Placebo-augmented CBT | 20 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | D-cycloserine-augmented CBT | ||
| Total, all-cause mortality | Placebo-augmented CBT | ||
| Total, other adverse events | D-cycloserine-augmented CBT | 0 | 87 |
| Total, other adverse events | Placebo-augmented CBT | 0 | 82 |
| Total, serious adverse events | D-cycloserine-augmented CBT | 0 | 87 |
| Total, serious adverse events | Placebo-augmented CBT | 0 | 82 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01MH075889 | D-Cycloserine Enhancement of Exposure in Social Phobia | POLLACK, MARK H | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL INSTITUTE OF MENTAL HEALTH | 2007 to 2010 | NIH RePORTER |
| R01MH078308 | D-Cycloserine Enhancement of Exposure in Social Phobia | HOFMANN, STEFAN G. | BOSTON UNIVERSITY (CHARLES RIVER CAMPUS) | NATIONAL INSTITUTE OF MENTAL HEALTH | 2007 to 2010 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| D-cycloserine-augmented CBT vs Placebo-augmented CBT: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00515879
GET https://conductscience.org/api/trials/v1/NCT00515879/results?page=2