Panic Disorder
Conditions
Keywords
Panic disorder, Exercise, Alprazolam, Aerobic
Brief 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.
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.
Interventions
DRUGAlprazolam
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.
DRUGAlprazolam + Aerobic exercise
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).
Sponsors
University of Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
Argentina
Participant flow
Recruitment details
180 patients were preselected for the study and 150 were eligible for the study. They were outpatients from the office practice and were recruited from March 2005 to July 2007.
Pre-assignment details
30 selected patients were not included: 12 did not match the 20 points for the Hamilton Anxiety Scale; 10 had history of medical diseases (5 of hypothyroidism, 4 of hypertension, and 1 of chronic fatigue syndrome); 8 had other associated psychiatric diseases: (5 had major depressive disorder and 3 had social anxiety disorder).
Participants by arm
| Arm | Count |
|---|---|
| Alprazolam Patients receiving only alprazolam | 75 |
| Alprazolam + Aerobic Exercise Patients receiving alprazolam + aerobic exercise | 75 |
| Total | 150 |
Baseline characteristics
| Characteristic | Total | Alprazolam | Alprazolam + Aerobic Exercise |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants | 75 Participants | 75 Participants |
| Age, Continuous | 34.85 years STANDARD_DEVIATION 7.89 | 34.01 years STANDARD_DEVIATION 8.07 | 35.68 years STANDARD_DEVIATION 7.67 |
| Region of Enrollment Argentina | 150 participants | 75 participants | 75 participants |
| Sex: Female, Male Female | 112 Participants | 57 Participants | 55 Participants |
| Sex: Female, Male Male | 38 Participants | 18 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 75 | 39 / 75 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 |
Outcome results
Primary
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alprazolam | Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale | 22.59 Units on a scale | Standard Deviation 2.09 |
| Alprazolam + Aerobic Exercise | Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale | 22.73 Units on a scale | Standard Deviation 1.98 |
Comparison: A p-value less than 0.05 (≤ 0.05) is statistically significant. It indicates strong evidence against the null hypothesis, as there is less than a 5% probability the null is correct (and the results are random)p-value: <0.001t-test, 1 sided
Secondary
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.
Time frame: Baseline and 12 weeks
Population: Patients with history of Panic Disorder
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alprazolam | Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) | 2.70 Score on a scale | Standard Deviation 0.62 |
| Alprazolam + Aerobic Exercise | Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) | 1.86 Score on a scale | Standard Deviation 0.6 |
Secondary
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).
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alprazolam | Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) | 4.05 Units on a scale | Standard Deviation 0.23 |
| Alprazolam + Aerobic Exercise | Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) | 4.06 Units on a scale | Standard Deviation 0.24 |