Trial Outcomes & Findings for Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment (NCT NCT00803400)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

150 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-08-19

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	Alprazolam Pacients receiving only alprazolam	Alprazolam + Aerobic Exercise Pacients receiving alprazolam + aerobic exercise
Overall Study STARTED	75	75
Overall Study COMPLETED	55	51
Overall Study NOT COMPLETED	20	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alprazolam n=75 Participants Patients receiving only alprazolam	Alprazolam + Aerobic Exercise n=75 Participants Patients receiving alprazolam + aerobic exercise	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34.01 years STANDARD_DEVIATION 8.07 • n=5 Participants	35.68 years STANDARD_DEVIATION 7.67 • n=7 Participants	34.85 years STANDARD_DEVIATION 7.89 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	55 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment Argentina	75 participants n=5 Participants	75 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Alprazolam n=75 Participants Patients receiving only alprazolam	Alprazolam + Aerobic Exercise n=75 Participants Patients receiving alprazolam + aerobic exercise
Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale	22.59 Units on a scale Standard Deviation 2.09	22.73 Units on a scale Standard Deviation 1.98

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Alprazolam n=75 Participants Patients receiving only alprazolam	Alprazolam + Aerobic Exercise n=75 Participants Patients receiving alprazolam + aerobic exercise
Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)	4.05 Units on a scale Standard Deviation 0.23	4.06 Units on a scale Standard Deviation 0.24

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Patients with history of Panic Disorder

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.

Outcome measures

Outcome measures
Measure	Alprazolam n=55 Participants Patients receiving only alprazolam	Alprazolam + Aerobic Exercise n=51 Participants Patients receiving alprazolam + aerobic exercise
Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)	2.70 Score on a scale Standard Deviation 0.62	1.86 Score on a scale Standard Deviation 0.60

Adverse Events

Alprazolam

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Alprazolam + Aerobic Exercise

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Alprazolam n=75 participants at risk Pacients receiving only alprazolam	Alprazolam + Aerobic Exercise n=75 participants at risk Pacients receiving alprazolam + aerobic exercise
Nervous system disorders Somnolence	37.3% 28/75 • Number of events 52 • Adverse event data were collected for 12 weeks Definition of adverse events are similar of those taken from clinicaltrials.gov	45.3% 34/75 • Number of events 60 • Adverse event data were collected for 12 weeks Definition of adverse events are similar of those taken from clinicaltrials.gov
Nervous system disorders Dizziness	5.3% 4/75 • Number of events 8 • Adverse event data were collected for 12 weeks Definition of adverse events are similar of those taken from clinicaltrials.gov	6.7% 5/75 • Number of events 9 • Adverse event data were collected for 12 weeks Definition of adverse events are similar of those taken from clinicaltrials.gov

Additional Information

Dr. Marcelo Rudelir

Psychiatry Academic Unit at J.A.Fernandez Hospital, University of Buenos Aires Medicine School Department of Mental Health

Phone: 54 11 48254740

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place