This study aims to evaluate the effect of benzodiazepines (especially alprazolam) on blood glucose of panic patients. 45 adult panic patients in the age group of 18 and over in the individuals who refer to psychiatric clinics affiliated to Babol University of Medical Sciences (in Ayatollah Rouhani and Shahid Yahyanejad Hospitals) will be allocated randomly in the three groups: sertraline; sertraline plus alprazolam; and sertraline plus clonazepam. At first, the weight, height, fasting blood glucose, two hours post-prandial blood glucose and HgA1C will be tested in all patients. Intervention group will receive 1.5-4 milligram per day alprazolam besides 50-200 milligram sertraline (based on the patient´s treatment response). Control group will receive only 50-200 milligram sertraline per day and alprazolam will be prescribed 0.5 milligram as needed- if panic attack occurs-. Another intervention group will receive 1.5-4 milligram per day clonazepam besides 50-200 milligram sertraline. The patients will be examined in twelve weeks; they will be visited by a psychiatrist monthly and their symptoms will be assessed. The number of panic attacks will be recorded weekly. Finally, fasting blood glucose, two hours post-prandial blood glucose and HgA1C will be tested again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040722991N3
Registration date:2016-04-21, 1395/02/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-21, 1395/02/02
Registrant information
Name
Sussan Moudi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 5683
Email address
sussan.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment for compare the effect of alprazolam and clonazepam on blood glucose in adult panic patients
Public title
Effect of alprazolam and clonazepam on blood glucose in adult panic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18 years and over; filling out the informed consent form; psychiatric diagnosis of panic disorder; no desire to be pregnant during the study and to use proper contraceptive; no use of psychoactive drugs at least in one week before entering the study
Exclusion criteria: active suicidal thoughts; disorders in which it is contraindicated to use sertraline, alprazolam and clonazepam; past history or having psychotic or bipolar disorders; pregnancy or breast feeding; uncontrolled convulsion disorders; a personality disorder in severity which worsens the evaluation of efficacy and safety of treatment; co-treatment with other psychotropic drugs; diabetes mellitus
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
University of Medical Sciences, Babol
City
Babol
Postal code
Approval date
2016-01-17, 1394/10/27
Ethics committee reference number
Mubabol.Rec.1394.255
Health conditions studied
1
Description of health condition studied
panic disorder
ICD-10 code
F41.0
ICD-10 code description
Panic disorder [episodic paroxysmal anxiety]
Primary outcomes
1
Description
fasting blood glucose
Timepoint
12th week
Method of measurement
blood test
2
Description
two hours post-prandial blood glucose
Timepoint
12th week
Method of measurement
blood test
3
Description
Hemoglubine A!C
Timepoint
12th week
Method of measurement
blood test
Secondary outcomes
1
Description
the number of panic attacks
Timepoint
weekly
Method of measurement
psychiatric visit
Intervention groups
1
Description
Intervention group 1: 1.5-4 milligram per day alprazolam besides 50-200 milligram sertraline for 12 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: 1.5-4 milligram per day clonazepam besides 50-200 milligram sertraline for 12 weeks
Category
Treatment - Drugs
3
Description
Control group: 50-200 milligram sertraline per day for 12 weeks