Trial · NCT00803400
Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment
NCT00803400, Phase 4, Completed, University of Buenos Aires; results first posted 2008-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment. Trials, record NCT00803400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00803400
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment
- NCT number
- NCT00803400
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 150 participants, actual
- Lead sponsor
- University of Buenos Aires
- Conditions
- Panic Disorder
- Interventions
- Alprazolam, Alprazolam + Aerobic exercise
- First posted
- 2008-12-05
- Last updated
- 2021-08-19
- Results first posted
- 2008-12-05
- Limitations and caveats
- Panic patients may sometimes be reluctant to use medication. This could lead to early drop outs.~Possible difficulties in following the exercise protocol.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale | 12 weeks | The Hamilton Anxiety Rating Scale is a test that consists of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Each of the 14 items measure both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety)with a total score range of 0-56, where 17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe. |
| Secondary | Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) | Baseline and 12 weeks | The Clinical Global Impression Severity scale is a 7 point ordinal scale that rates the severity of the patient's illness, assessing on the severity of a patient's mental illness. It ranges from 1 to 7 (1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; 7, extremely ill). |
| Secondary | Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) | Baseline and 12 weeks | The Clinical Global Impression Improvement Scale is a 7 point ordinal scale that assesses how much the patient's illness has improved or worsened relative to a baseline state before the intervention. Rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale | 12 weeks | Units on a scale | MEAN | |
| SECONDARY | Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) | Baseline and 12 weeks | Units on a scale | MEAN | |
| SECONDARY | Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) | Baseline and 12 weeks | Patients with history of Panic Disorder | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale | Alprazolam | 22.59 | Standard Deviation 2.09 | Units on a scale | |
| Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale | Alprazolam + Aerobic Exercise | 22.73 | Standard Deviation 1.98 | Units on a scale | |
| Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) | Alprazolam | 4.05 | Standard Deviation 0.23 | Units on a scale | |
| Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) | Alprazolam + Aerobic Exercise | 4.06 | Standard Deviation 0.24 | Units on a scale | |
| Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) | Alprazolam | 2.70 | Standard Deviation 0.62 | Score on a scale | |
| Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) | Alprazolam + Aerobic Exercise | 1.86 | Standard Deviation 0.60 | Score 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 | Alprazolam | 75 | |
| Overall Study | STARTED | Alprazolam + Aerobic Exercise | 75 | |
| Overall Study | COMPLETED | Alprazolam | 55 | |
| Overall Study | COMPLETED | Alprazolam + Aerobic Exercise | 51 | |
| Overall Study | NOT COMPLETED | Alprazolam | 20 | |
| Overall Study | NOT COMPLETED | Alprazolam + Aerobic Exercise | 24 |
Source ClinicalTrials.gov
Adverse events4
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 | Somnolence | Nervous system disorders | Alprazolam | 28 | 75 | 52 |
| other | Somnolence | Nervous system disorders | Alprazolam + Aerobic Exercise | 34 | 75 | 60 |
| other | Dizziness | Nervous system disorders | Alprazolam | 4 | 75 | 8 |
| other | Dizziness | Nervous system disorders | Alprazolam + Aerobic Exercise | 5 | 75 | 9 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alprazolam | ||
| Total, all-cause mortality | Alprazolam + Aerobic Exercise | ||
| Total, other adverse events | Alprazolam | 32 | 75 |
| Total, other adverse events | Alprazolam + Aerobic Exercise | 39 | 75 |
| Total, serious adverse events | Alprazolam | 0 | 75 |
| Total, serious adverse events | Alprazolam + Aerobic Exercise | 0 | 75 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 15957014 | BACKGROUND |
Source PubMed
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 |
|---|
| Alprazolam vs Alprazolam + Aerobic Exercise: 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/NCT00803400
GET https://conductscience.org/api/trials/v1/NCT00803400/registered