Effect of aripiprazole in treatment of sexual dysfunction due to antidepressants

Phase 2

• Conditions: 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

• Registration Number: IRCT2017020432236N5
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).