Condition 1: Sexual desire. Condition 2: Sexual dysfunction. Condition 3: Orgasm. Condition 4: Ejaculation. Lack or loss of sexual desire Sexual dysfunction, not caused by organic disorder or disease Orgasmic dysfunction Premature ejaculation
Conditions
Interventions
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 fi
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 w
The placebo group receive placebo, which made as same as aripiprazole, along with their SSRIs or SNRIs regimen for six weeks
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Narjes Hendouei
Mazandaran University of Medical Sciences
Outcome results
None listed