Trial · NCT00790868
Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder
NCT00790868, Phase 2, Completed, Boston University Charles River Campus; results first posted 2018-03-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder. Trials, record NCT00790868. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00790868
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder
- NCT number
- NCT00790868
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 180 participants, actual
- Lead sponsor
- Boston University Charles River Campus
- Conditions
- Panic Disorder
- Interventions
- d-cycloserine, placebo
- First posted
- 2008-11-14
- Last updated
- 2018-03-07
- Results first posted
- 2018-03-07
- Limitations and caveats
The investigators did not systematically collect fear estimates across exposure and are therefore unable to examine this factor as a moderator.~Unexpected site effects were observed for several of our outcome variables.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Panic Disorder Severity Scale (PDSS) | baseline, mid-TX, post-TX, follow-up visits 1-4 | The percent change in PDSS score from baseline to the relevant assessment points is the continuous primary outcome measure. The PDSS consists of seven items, each rated on a 0 to 4 scale (0 denoting none, and higher ratings reflecting greater degrees of symptom severity; for a possible range in scores from 0 to 28). In the tabular data below we present the total scores (sum of items). |
| Primary | Remission Status | Pre-treatment, Post-Treatment, and each follow-up sessions | Remission status will be used as the primary categorical outcome variable. The CGI-S was used in determining whether patients met the "CGI-S of 1 or 2" component of the "remission status" criteria (i.e., zero panic attacks and CGI-S of 1 or 2 at endpoint). No values are missing because remission must be confirmed; missing status is assigned to disorder status. Hence results are for the full randomized sample. |
| Secondary | Depression Severity | Baseline, Tx Endpoint, Each of 4 follow-up assessments | Depression severity was assessed with the MADRS, with scores ranging from 0 to 60. Higher scores indicate greater depression. |
| Secondary | Quality of Life Ratings | Baseline, Tx Endpoint, Each of 4 follow-up assessments | Quality of life as assessed by the Q-LES-Q. Scores range from 14-70 for total raw score, higher scores indicate higher quality of life ratings. |
| Secondary | Role Functioning | Baseline, Tx Endpoint, Each of 4 follow-up assessments | LIFE-RIFT. For this clinician-rated measure, total scores range from 0 to 20, with higher scores indicating greater impairment |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Panic Disorder Severity Scale (PDSS) | baseline, mid-TX, post-TX, follow-up visits 1-4 | Seventeen subjects out of 92 (five during treatment and 12 during follow-up, 20% total) in the control group compared to six out of 88 (four during treatment and two during follow-up, 10% total) in the DCS group dropped out. | units on a scale | MEAN |
| PRIMARY | Remission Status | Pre-treatment, Post-Treatment, and each follow-up sessions | Full sample of 180 randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Depression Severity | Baseline, Tx Endpoint, Each of 4 follow-up assessments | Randomized participants with panic disorder | units on a scale | MEAN |
| SECONDARY | Quality of Life Ratings | Baseline, Tx Endpoint, Each of 4 follow-up assessments | Randomized participants | units on a scale | MEAN |
| SECONDARY | Role Functioning | Baseline, Tx Endpoint, Each of 4 follow-up assessments | Randomized sample | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Panic Disorder Severity Scale (PDSS) | D-cycloserine | Baseline | 13.30 | Standard Deviation 4.50 | units on a scale |
| Panic Disorder Severity Scale (PDSS) | Placebo | Baseline | 13.37 | Standard Deviation 3.39 | units on a scale |
| Panic Disorder Severity Scale (PDSS) | D-cycloserine | TX Midpoint | 7.98 | Standard Deviation 3.92 | units on a scale |
| Panic Disorder Severity Scale (PDSS) | Placebo | TX Midpoint | 8.32 | Standard Deviation 4.19 | units on a scale |
| Panic Disorder Severity Scale (PDSS) | D-cycloserine | TX Endpoint | 5.30 | Standard Deviation 3.52 | units on a scale |
| Panic Disorder Severity Scale (PDSS) | Placebo | TX Endpoint | 6.43 | Standard Deviation 4.63 | units on a scale |
| Panic Disorder Severity Scale (PDSS) | D-cycloserine | Follow-Up 1 | 4.76 | Standard Deviation 3.82 | units on a scale |
| Panic Disorder Severity Scale (PDSS) | Placebo | Follow-Up 1 | 5.84 | Standard Deviation 4.36 | units on a scale |
| Panic Disorder Severity Scale (PDSS) | D-cycloserine | Follow-Up 2 | 4.38 | Standard Deviation 3.50 | units on a scale |
| Panic Disorder Severity Scale (PDSS) | Placebo | Follow-Up 2 | 4.53 | Standard Deviation 4.03 | units on a scale |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 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 | 88 | |
| Overall Study | STARTED | Placebo | 92 | |
| Overall Study | COMPLETED | D-cycloserine | 82 | |
| Overall Study | COMPLETED | Placebo | 75 | |
| Overall Study | NOT COMPLETED | D-cycloserine | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 17 |
Source ClinicalTrials.gov
Adverse events44
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 | Nausea/vomiting | Gastrointestinal disorders | D-cycloserine | 6 | 88 | |
| other | Nausea/vomiting | Gastrointestinal disorders | Placebo | 7 | 92 | |
| other | Gastrointestinal distress | Gastrointestinal disorders | D-cycloserine | 2 | 88 | |
| other | Gastrointestinal distress | Gastrointestinal disorders | Placebo | 3 | 92 | |
| other | Headache | General disorders | D-cycloserine | 4 | 88 | |
| other | Headache | General disorders | Placebo | 3 | 92 | |
| other | Fatigue | General disorders | D-cycloserine | 11 | 88 | |
| other | Fatigue | General disorders | Placebo | 3 | 92 | |
| other | Sedation | General disorders | D-cycloserine | 5 | 88 | |
| other | Sedation | General disorders | Placebo | 3 | 92 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | D-cycloserine | 0 | 88 |
| Total, all-cause mortality | Placebo | 0 | 92 |
| Total, other adverse events | D-cycloserine | 17 | 88 |
| Total, other adverse events | Placebo | 18 | 92 |
| Total, serious adverse events | D-cycloserine | 1 | 88 |
| Total, serious adverse events | Placebo | 1 | 92 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27315514 | RESULT |
Source PubMed
Grants1
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 |
|---|---|---|---|---|---|
| R01MH081116 | 1/3-Exposure D-Cycloserine Enhancement and Genetic Modulators in Panic Disorder | OTTO, MICHAEL W. | BOSTON UNIVERSITY (CHARLES RIVER CAMPUS) | NATIONAL INSTITUTE OF MENTAL HEALTH | 2008 to 2012 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| D-cycloserine vs Placebo: deaths from any cause | Trial comparisons |
| D-cycloserine vs Placebo: serious adverse events | 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/NCT00790868
GET https://conductscience.org/api/trials/v1/NCT00790868/results?page=2