The aim of the present study is to compare two proposed medication (bupropion vs. amantadine) in alleviating sexual dysfunction of patients treated with Selective Serotonin Reuptake Inhibitors. The study was a semi-experimental, single-blind, 4-week trial. The outpatients treated with Selective Serotonin Reuptake Inhibitors and in remission for more than 8 weeks and have sexual dysfunction, were randomly allocated to two parallel groups. Inclusion criteria: patients who had a diagnosis of Major depression disorder; were in remission while taking a stable dose of Selective Serotonin Reuptake Inhibitors for at least 8 weeks; exclusion criteria: patients with any previous sexual dysfunction; relapse of major depression; body mass index of ≥ 30 kg/m; had a sexual partner with a history of sexual dysfunction. Twenty patients were given bupropion 200mg/day .Eighteen patients were randomly assigned to another group; given amantadine 200 mg/day.Patients were assessed with the Arizona Sexual Experience Scale (ASEX) at baseline and 4 weeks after the start of the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409275280N17
Registration date:2014-10-27, 1393/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-27, 1393/08/05
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of bupropion and amantadine on sexual dysfunction induced by a selective serotonin reuptake inhibitor
Public title
Comparing the efficacy of bupropion and amantadine on sexual dysfunction induced by a selective serotonin reuptake inhibitor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who had a diagnosis of Major depression disorder; were in remission while taking a stable dose of Selective Serotonin Reuptake Inhibitors for at least 8 weeks;
exclusion criteria:patients with any previous sexual dysfunction ; relapse of major depression;body mass index of ≥ 30 kg/m; had a sexual partner with a history of sexual dysfunction.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
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
Ethic Committee Shahid Beheshti University of Medical Sciences
Street address
Tehran
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
5950
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
sexual dysfunction
Timepoint
Baseline and 4 weeks after treatment.
Method of measurement
Arizona Sexual Experience Scale (ASEX)
Secondary outcomes
empty
Intervention groups
1
Description
The patients were given bupropion 200mg/day for the period of4 weeks.
Category
Treatment - Drugs
2
Description
patients were assigned to another group and were given amantadine 200 mg/day for the period of4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry Clinic
Full name of responsible person
Dr Farhad Faridhosseini
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Zarghi
Street address
Tehran
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 of Shahid 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Farhad Faridhoseini
Position
Assistant Pofessor
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital, Hore Ameli blv.
City
Mashhad
Postal code
Phone
+98 51 3711 2721
Fax
Email
faridhoseinif@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Farhad Faridhoseini
Position
Assistant Professor
Other areas of specialty/work
Street address
Ibn-E- Sina Hospital
City
Mashhad
Postal code
Phone
+98 51 3711 2721
Fax
Email
faridhosseinif@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raheleh Nejati
Position
Master of Science
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)