The goal of this study is to assess the efficacy of Aspirin in the treatment of sexual dysfunction induced by lithium. Forty patients, who are in remission phase of bipolar disorder and are on lithium maintenance and have sexual dysfunction based on international index of erectile function, will be entered into our study. Patients will be excluded if they have other psychiatric comorbidity, substance dependence, GI bleeding. Before entering into the study, informed consent will be obtained. The serum level of lithium should be 0.6-1.00 MEq/lit. One group will receive Aspirin (coated) 240 mg/day and the second group will receive Placebo for 6 weeks. During the trial, patients will be assessed by international index of erectile function.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711131556N4
Registration date:2009-02-12, 1387/11/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2009-02-12, 1387/11/24
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-02-20, 1387/12/02
Expected recruitment end date
2010-02-20, 1388/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Aspirin efficacy in prevention of erectile dysfunction due to lithium administration in comparison with placebo
Public title
Aspirin in the treatment of sexual dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Remission phase of bipolar disorder, maintenance on lithium, sexual dysfunction based on international index of erectile function. Exclusion Criteria: Other psychiatric comorbidity, substance dependence, GI bleeding.
Age
From 20 years old to 45 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
Tehran
Postal code
Approval date
2009-01-22, 1387/11/03
Ethics committee reference number
8146
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Score of international index of erectile function
Timepoint
every two week
Method of measurement
use of international index of erectile function
Secondary outcomes
empty
Intervention groups
1
Description
Asprin (80 mg TDS) as intervention group
Category
Treatment - Drugs
2
Description
Tab Placebo as control group
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh psychiatric Hospital
Full name of responsible person
Dr. Seyed Ali Ahmadi Abhari
Street address
Roozbeh psychiatric Hospital, South Kargar
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. akbar Fotouhi
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Ph.D., FBPharmacolS., Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Psychiatric Hospital
City
Tehran
Postal code
13337
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Ph.D., FBPharmacolS, Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Psychiatric Hospital
City
Tehran
Postal code
13337
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)