Assessing approaches aimed at improving sexual functioning

Not Applicable

Completed

• Conditions: Antipsychotic-Induced Sexual Dysfunction; Not Applicable; Complications of medical and surgical care

• Registration Number: ISRCTN12307891
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32930090/ results (added 16/09/2020) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35953808/ Qualitative results of interviews exploring barriers to recruitment (added 12/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-20
• Study Completion: 2021-10-31
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Men or women aged 18 or over
2. A clinical diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis not otherwise specified, as defined by DSM-IV
3. Sexual dysfunction associated with antipsychotic medication for whom reducing the dose of their current antipsychotic was either not effective or not appropriate
4. Assessed by their clinical team as not having an underlying physical condition that is responsible for their sexual dysfunction

Exclusion Criteria

1. Acutely psychotic or have been so within the last 3 months
2. Unable to speak sufficient English to complete the baseline assessment
3. Currently prescribed clozapine as this medication is restricted to those with treatment resistant psychosis
4. Current sexual problems started prior to their taking antipsychotic medication
5. Currently taking part in another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient reported sexual dysfunction measured using the Arizona Sexual Experience scale (ASEX) at baseline, 3 and 6 months. Primary outcome at 6 months.