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IRCT2017020432236N5 IRCT 2017-04-02 Mazandaran University of Medical Sciences Effect of aripiprazole in treatment of sexual dysfunction due to antidepressants Evaluation of efficacy and safety of aripiprazole in treatment of Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) induced sexual dysfunction: a randomized double blind controlled trial 2015-11-22 anticipated 60 Complete https://irct.ir/trial/25162 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This is a randomized double blind controlled study. The participants and assessor are aware of neither drugs nor placebo. The block randomization method is used . 2-3 Condition 1: Sexual desire. Condition 2: Sexual dysfunction. Condition 3: Orgasm. Condition 4: Ejaculation. Intervention 1: Subjects in the intervention group receive aripiprazole with an initial dose of 5 milligram aripiprazole per day on the first week, then 10 milligrams per day on the second week and finally the dose will increase to 15 milligrams per day on the third week and continue with the same dose along with SSRIs or SNRIs for six weeks. Intervention 2: The placebo group receive placebo, which made as same as aripiprazole, along with their SSRIs or SNRIs regimen for six weeks.
public Dr Narjes Hendouei
Department of Pharmacotherapy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sea road, Sari, Mazandaran, Iran
Sari Iran (Islamic Republic of) +98 11 3354 3081 hendoieen@yahoo.com Mazandaran University of Medical Sciences scientific Dr Narjes Hendouei
Department of Pharmacotherapy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sea road, Sari, Mazandaran, Iran
Sari Iran (Islamic Republic of) +98 11 3354 3081 hendoieen@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Outpatients with psychiatric disorders according to the fifth edition of Diagnostic and Statistical Manual of Psychiatric Disorders treated with serotonin specific reuptake inhibitor or serotonin norepinephrine reuptake inhibitor in the age range of 18-50 year-old; Suffer from sexual dysfunction according to the fifth edition of Diagnostic and Statistical Manual of Psychiatric Disorders; Having a regular and satisfying sexual activity before taking the serotonin specific reuptake inhibitor or serotonin norepinephrine reuptake inhibitor; Enable in sexual function Exclusion criteria: Having sexual dysfunction before serotonin specific reuptake inhibitor or serotonin norepinephrine reuptake inhibitor; History of substance use interfere with sexual function (eg, alcohol, drugs, drug abuse or dependence during the past twelve months or positive urine test for illicit drugs); Electroconvulsive therapy during the 6 past months; Suicidality(active suicide or homicide intent, or a suicide or homicide attempt in the preceding 6 months); Mental retardation; Pregnant or at risk of pregnancy; Cognitive disorders such as dementia, delirium, or amnesia, traumatic brain injury; Current significant unstable medical illness (such as unstable cardiac disease, hepatic or renal impairment, evidence or history of malignancy or any significant hematological, endocrine); Axis II psychiatric disorders; Family history of bipolar disorder; Concomitant use with other psychiatric drugs; Hypersensitivity to aripiprazole; Previous treatment with aripiprazole in the past year; History of neuroleptic malignant syndrome; Unwilling or unable, in the opinion of the Investigator, to comply with study instructions 18 years 50 years Both F52.0 F52 F52.3 F52.4 Lack or loss of sexual desire Sexual dysfunction, not caused by organic disorder or disease Orgasmic dysfunction Premature ejaculation Treatment - Drugs Placebo Subjects in the intervention group receive aripiprazole with an initial dose of 5 milligram aripiprazole per day on the first week, then 10 milligrams per day on the second week and finally the dose will increase to 15 milligrams per day on the third week and continue with the same dose along with SSRIs or SNRIs for six weeks The placebo group receive placebo, which made as same as aripiprazole, along with their SSRIs or SNRIs regimen for six weeks Sexual function enhancement. Timepoint: weeks 0,2,4,6. Method of measurement: Arizona Sexual Experience Involuntary (ASEX), Female Sexual Function Index (FSFI), International Index of Erectile Function (IIEF). Akathisia advers effect due to aripiprazole. Timepoint: weeks0,2,4,6. Method of measurement: Barns Akathisia Rating Scale (BARS). Movement effect of aripiprazole. Timepoint: weeks0,2,4,6. Method of measurement: Abnormal Involuntary Movement Scale (AIMS). Mazandaran University of Medical Sciences Approved 2010-09-23 Vice president of research, Mazandaran University of Medical Sciences Vice president of research, Mazandaran University of Medical Sciences, Moallem street, Moallem square, Sari, Mazandaran, Iran Sari Iran (Islamic Republic of)