Panic DisorderPhase 4AEIPDTNCT00803400
Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment
A Phase 4 study testing Alprazolam and Alprazolam + Aerobic exercise in people with Panic Disorder, run by University of Buenos Aires at 1 site in Argentina.
Trial summary
The purpose of this study is to determine whether the combination of aerobic physical exercise and alprazolam in patients with panic disorder has a better therapeutic response than the treatment with alprazolam alone. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Alprazolam and Alprazolam + Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Oct 2008to 30 Sep 2009
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with panic disorder scored between 20 and 30 by the Hamilton Anxiety Rating Scale/14. (Baseline scale scores were measured during the first interview and diagnoses were made by a psychiatrist using the Structured Clinical Interview for DSM IV).
- Good physical health and normal results determined on a previous physical examination and routine laboratory tests (renal, hepatic, hematological and thyroid function).
- Patients who completed a written informed consent form (which was obtained from every included patient and had been fully explained before the procedure).
Who cannot join
- A history of some kind of recent somatic disease.
- Diagnosis of some other type of associated or psychiatric disease of axis I of DSM IV, such as affective disorders, drug dependency.
- Hamilton Anxiety Scale lower than 20 points or higher than 30.
- Use of some other type of medication or treatment (including psychotherapy) or having received it during last past 3 months.
- Patients who could not complete the clinical examination
- Patients who have not accepted to complete or sign the written informed consent.
- Pregnant patients or in lactation. (A pregnancy test was performed for women in fertile age)
- Patients with history of rejection to the used drug.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Mental Health
Buenos Aires, Buenos Aires F.D., 1425
About this study
Official title: Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment: a Clinical Randomized Trial
The purpose of this study is to determine whether the combination of aerobic physical exercise and alprazolam in patients with panic disorder has a better therapeutic response than the treatment with alprazolam alone.
Read the detailed description
We have observed in our clinical practice that patients who practiced aerobic physical exercise had faster remissions and better improvement in their treatments that those who did not. There are also some scientific studies that included physical exercise in the treatment for panic disorder and compared them to other single pharmacological treatments.
So our objective will be to compare the efficacy of a pharmacological monotherapy (alprazolam), that is one of the options for the pharmacological treatment of panic disorder, with other treatment such as the combination of aerobic physical exercise and alprazolam, and to determine if this combination results in a better therapeutic response.
- Conditions
- Panic Disorder
- Being tested
- Alprazolam, Alprazolam + Aerobic exercise
- Keywords
- Panic disorder, Exercise, Alprazolam, Aerobic
- Medical subject headings
- Panic Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprazolamDrug
Also called Non exercise group
The patients assigned to the pharmacological plan will receive 4 mg alprazolam daily for 12 weeks. Two weeks after the first interview they have their first baseline psychiatric control, where all the patients are tested.
Then, at the same visit, all the patients are indicated 4 mg of alprazolam. The dose is gradually increased from 1 to 4 mg along the first week of treatment. The test is repeated during weeks 2, 4, 8 and 12.
Alprazolam + Aerobic exerciseDrug
Also called Exercise group
The patients assigned to exercise have to pass an ergometric test to determine their functional capacity expressed in METs for future exercise indication.
Two weeks after the first interview they have their first baseline psychiatric control and at the same time they are indicated a 4 mg dose of alprazolam, gradually increased from 1 to 4 mg along the first week of treatment. The test is repeated during weeks 2, 4, 8 and 12.
Then they follow a protocolized aerobic exercise plan for this study during 12 weeks.
The type of selected exercise consists of a rapid walk for 30 minutes divided in stages.
After each stage the patient has to control his own heart frequency that has to be between 50 and 75% of their maximum to assure an aerobic condition (American Cardiological Association).
| Study group | Role | What they receive |
|---|---|---|
| Alprazolam | Active comparator | Patients assigned to the pharmacological plan Receives: Drug: Alprazolam |
| Alprazolam + Aerobic exercise | Active comparator | Patients assigned to mix plan Receives: Drug: Alprazolam + Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale
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.
Measured: 12 weeks
Secondary outcomes (2)
Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)
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).
Measured: Baseline and 12 weeks
Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study start1 Oct 2008
- Primary completion1 Mar 2009
- Study completion30 Sep 2009
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 (1)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Marcelo Rudelir, University of Buenos Aires
- Investigators
- Marcelo G Rudelir, MD, Principal investigator, Psychiatry and Mental Health Department at University of Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803400
- Sponsor's protocol ID
- UDHFMEDUBA0709
- Acronym
- AEIPDT
- Status last verified
- Jul 2021
- First submitted
- 7 Nov 2008
- Last updated
- 19 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toro Martinez E, Rudelir M. [Assessment of suicide risk: clinical and legal aspects]. Vertex. 2005 May-Jun;16(61):196-205. Spanish.
PubMed 15957014
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment: a Clinical Randomized Trial
- ClinicalTrials.gov ID
- NCT00803400
- Acronym / sponsor ID
- AEIPDT / UDHFMEDUBA0709
- Conditions
- Panic Disorder
- Keywords
- Panic disorder, Exercise, Alprazolam, Aerobic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Buenos AiresUniversity, hospital or other
- Study start
- 1 Oct 2008 (actual)
- Primary completion
- 1 Mar 2009 (actual)
- Study completion
- 30 Sep 2009 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Posted 5 Dec 2008
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 determine whether the combination of aerobic physical exercise and alprazolam in patients with panic disorder has a better therapeutic response than the treatment with alprazolam alone.
Detailed description
We have observed in our clinical practice that patients who practiced aerobic physical exercise had faster remissions and better improvement in their treatments that those who did not. There are also some scientific studies that included physical exercise in the treatment for panic disorder and compared them to other single pharmacological treatments.
So our objective will be to compare the efficacy of a pharmacological monotherapy (alprazolam), that is one of the options for the pharmacological treatment of panic disorder, with other treatment such as the combination of aerobic physical exercise and alprazolam, and to determine if this combination results in a better therapeutic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alprazolam | Active comparator | Drug: AlprazolamPatients assigned to the pharmacological plan |
| Alprazolam + Aerobic exercise | Active comparator | Drug: Alprazolam + Aerobic exercisePatients assigned to mix plan |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with panic disorder scored between 20 and 30 by the Hamilton Anxiety Rating Scale/14. (Baseline scale scores were measured during the first interview and diagnoses were made by a psychiatrist using the Structured Clinical Interview for DSM IV).
- Good physical health and normal results determined on a previous physical examination and routine laboratory tests (renal, hepatic, hematological and thyroid function).
- Patients who completed a written informed consent form (which was obtained from every included patient and had been fully explained before the procedure).
Key exclusion criteria (8 listed)
- A history of some kind of recent somatic disease.
- Diagnosis of some other type of associated or psychiatric disease of axis I of DSM IV, such as affective disorders, drug dependency.
- Hamilton Anxiety Scale lower than 20 points or higher than 30.
- Use of some other type of medication or treatment (including psychotherapy) or having received it during last past 3 months.
- Patients who could not complete the clinical examination
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 |
|---|---|---|
| AlprazolamAlso: Non exercise groupThe patients assigned to the pharmacological plan will receive 4 mg alprazolam daily for 12 weeks. Two weeks after the first interview they have their first baseline psychiatric control, where all the patients are tested. Then, at the same visit, all the patients are indicated 4 mg of alprazolam. The dose is gradually increased from 1 to 4 mg along the first week of treatment. The test is repeated during weeks 2, 4, 8 and 12. | Drug | Alprazolam |
| Alprazolam + Aerobic exerciseAlso: Exercise groupThe patients assigned to exercise have to pass an ergometric test to determine their functional capacity expressed in METs for future exercise indication. Two weeks after the first interview they have their first baseline psychiatric control and at the same time they are indicated a 4 mg dose of alprazolam, gradually increased from 1 to 4 mg along the first week of treatment. The test is repeated during weeks 2, 4, 8 and 12. Then they follow a protocolized aerobic exercise plan for this study during 12 weeks. The type of selected exercise consists of a rapid walk for 30 minutes divided in stages. After each stage the patient has to control his own heart frequency that has to be between 50 and 75% of their maximum to assure an aerobic condition (American Cardiological Association). | Drug | Alprazolam + Aerobic exercise |
Primary outcome
Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale
Time frame: 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.
2 secondary outcomes
Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)
Time frame: Baseline and 12 weeks
Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15957014Toro Martinez E, Rudelir M. [Assessment of suicide risk: clinical and legal aspects]. Vertex. 2005 May-Jun;16(61):196-205. Spanish.
- Psychiatry and Mental Health Department at University of Buenos AiresLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Marcelo G Rudelir, MD principal investigator
Psychiatry and Mental Health Department at University of Buenos Aires
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 Alprazolam and Alprazolam + Aerobic exercise in people with Panic Disorder, run by University of Buenos Aires at 1 site in Argentina.
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 3 inclusion and 8 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 19 Aug 2021. 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 Argentina. 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. 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 5 Dec 2008). 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?
Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale (time frame: 12 weeks). 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 NCT00803400, which also lists 1 linked publication.
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 19 Aug 2021.