Purpose of study: Comparison of Lorazepam and Zolpidem effect on insomnia. Study design: randomized, single blind, placebo not used, single recruitment center. Main inclusion criteria: Bone marrow transplantation patients that have insomnia base on SleepMed Insomnia Index questionnaire. Main exclusion criteria: Use of alcohol; Patients who have no remission in insomnia after taking 4 mg Lorazepam or 10 mg Zolpidem during 4 days; Addiction to opioids. Sample size: 35. Intervention: Medication initiates with 1 mg Lorazepam or 5 mg Zolpidem before noctural sleep. If the patient already takes another Benzodiazepine, it switchs to Lorazepam with equivalent dose. Intervention time: 1 month. Outcomes: characteristics and severity of the insomnia complaint in noctural sleep using scores obtain from the SleepMed Insomnia Index questionnaire, degree of day time sleepiness using Epworth Sleepiness Scale questionnaire and anxiety and depression using the Hospital Anxiety and Depression Scale questionnaire. Simultaneously patients are considered about side effects of drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811103210N2
Registration date:2011-10-16, 1390/07/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-16, 1390/07/24
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2010-11-07, 1389/08/16
Expected recruitment end date
2011-11-07, 1390/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Lorazepam and Zolpidem effect on insomnia in bone marrow trasplantation patients
Public title
Comparison of Lorazepam and Zolpidem effect on insomnia in bone marrow trasplantation patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Bone marrow transplantation patients that have insomnia base on the
SleepMed Insomnia Index questionnaire; Patients in range of 18-65 years old. Exclusion criteria: Sensitivity to Lorazepam or Zolpidem; Narrow-angle glaucoma; Pregnancy & breast feeding; Hepatic encephalopathy; Rising of hepatic enzymes ( AST, ALT, ALP, LDH ) 3 times the upper limit of normal; Serum creatinine concentration more than 2.5 mg/dl; Use of alcohol; Patients who have no remission in insomnia after taking 4 mg Lorazepam or 10 mg Zolpidem during 4 days; Addiction to opioids
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak street, Shaheed Chamran highway
City
Tehran
Postal code
Approval date
2010-11-07, 1389/08/16
Ethics committee reference number
91
Health conditions studied
1
Description of health condition studied
insomnia
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep
Primary outcomes
1
Description
sleepiness
Timepoint
Before intervention and 1, 2, 3 and 4 week after beginning of intervention
Method of measurement
Epworth sleepiness scale questionnaire
2
Description
Anxiety and Depression
Timepoint
Before intervention and 4 week after beginning of intervention
Method of measurement
Hospital Anxiety and Depression Scale questionnaire
3
Description
Insomnia
Timepoint
Before intervention and 1, 2, 3 and 4 weeks after beginning of intervention
Method of measurement
SleepMed Insomnia Index questionnaire
Secondary outcomes
1
Description
Central Nervous System side effects
Timepoint
1, 2, 3 and 4 week after beginning of intervention
Method of measurement
Clinical observation
2
Description
GastroIntestinal System side effects
Timepoint
1, 2, 3 and 4 week after beginning of intervention
Method of measurement
Clinical observation
Intervention groups
1
Description
Zolpidem, 5 mg oral tablet, once daily, before noctural sleep, during 1 month. it can increase up to 10 mg, for 4 days.
Category
Treatment - Drugs
2
Description
Lorazepam, 1 mg oral tablet, once daily, before noctural sleep, during 1 month. it can increase up to 4 mg for 4 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Maria Tavakoli Ardekani
Street address
Velenjak street, Shaheed Chamran highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Faculty of pharmcy, Shaheed Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Valiasr Ave, Niayesh highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Faculty of pharmcy, Shaheed Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of pharmacy, Shahid Beheshti University of Medical Sciencses
Full name of responsible person
Zeinab Emami
Position
Pharmacy student
Other areas of specialty/work
Street address
Valiasr Ave, Niayesh highway
City
Tehran
Postal code
Phone
+98 21 7791 9321
Fax
Email
zeinab_emami @yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of pharmacy, Shahid Beheshti University of Medical Scienses
Full name of responsible person
Dr Maria Tavakoli Ardakani
Position
Assistant professor, Academic member / PhD
Other areas of specialty/work
Street address
Valiasr Ave, Niayesh highway
City
Tehran
Postal code
6153-14155
Phone
+98 21 8820 0085
Fax
Email
mariatavakoli@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of pharmacy, Shahid Beheshti University of Medical Sciencses
Full name of responsible person
Zeinab Emami
Position
Pharmacy student
Other areas of specialty/work
Street address
Valiasr Ave, Niayesh highway
City
Tehran
Postal code
Phone
+98 21 7791 9321
Fax
Email
zeinab_emami@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)