Trial · NCT00114127
Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome
NCT00114127, Phase 3, Completed, Massachusetts General Hospital; results first posted 2012-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome. Trials, record NCT00114127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00114127
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome
- NCT number
- NCT00114127
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 28 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Anxiety Disorder
- Interventions
- Duloxetine, Duloxetine, Placebo
- First posted
- 2005-06-14
- Last updated
- 2014-06-10
- Results first posted
- 2012-06-07
- Limitations and caveats
- Open-label in phase Phase 1; Limited power due to small sample size.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale | 6 months | 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 with higher scores representing increased social anxiety. The LSAS contains three total scores: 1) total fear score (0-72), 2) total avoidance score(0-72), 3) and total overall score (0-144). Suggested interpretations: 55-65 Moderate social phobia, 65-80 Marked social phobia, 80-95 Severe social phobia, Greater than 95 - Very severe social phobia. |
| Secondary | CGI-S | 6 months | The Clinician Global Impression-Severity Scale (CGI-S) is a clinician-rated instrument used to assess global severity of symptoms (Guy, 1976). The CGI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Baseline collected for Phase 1 at week 0 and for Phase 2 at week 6. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale | 6 months | Scores on a scale | MEAN | |
| SECONDARY | CGI-S | 6 months | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale | Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 67.9 | Standard Error 7.60 | Scores on a scale | |
| Anxiety Symptoms as Assessed by Liebowitz Social Anxiety Scale | Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 53.7 | Standard Error 7.90 | Scores on a scale | |
| CGI-S | Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 4.42 | Standard Error 0.48 | Scores on a scale | |
| CGI-S | Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 3.60 | Standard Error 0.57 | Scores on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 13 | |
| Overall Study | STARTED | Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 15 | |
| Overall Study | COMPLETED | Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 9 | |
| Overall Study | COMPLETED | Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 11 | |
| Overall Study | NOT COMPLETED | Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 4 | |
| Overall Study | NOT COMPLETED | Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 4 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Sedation and other side effects | General disorders | Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 0 | 13 | 0 |
| other | Sedation and other side effects | General disorders | Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 1 | 15 | 1 |
| other | Increased drinking | General disorders | Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 0 | 13 | 0 |
| other | Increased drinking | General disorders | Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 1 | 15 | 1 |
| serious | Elevated Liver Function Tests | General disorders | Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 1 | 13 | 1 |
| serious | Elevated Liver Function Tests | General disorders | Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 0 | 15 | 0 |
| serious | Study medication overdose | General disorders | Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 1 | 13 | 1 |
| serious | Study medication overdose | General disorders | Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 0 | 15 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | ||
| Total, all-cause mortality | Duloxetine 120mg/Day for 18 Weeks (Phase 2) | ||
| Total, other adverse events | Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 0 | 13 |
| Total, other adverse events | Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 2 | 15 |
| Total, serious adverse events | Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) | 2 | 13 |
| Total, serious adverse events | Duloxetine 120mg/Day for 18 Weeks (Phase 2) | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2) vs Duloxetine 120mg/Day for 18 Weeks (Phase 2): 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/NCT00114127
GET https://conductscience.org/api/trials/v1/NCT00114127/registered