Assessing approaches aimed at improving sexual functioning

Conditions

Antipsychotic-Induced Sexual Dysfunction Not Applicable Complications of medical and surgical care

Lavanya Thana, Lesley O’Connell, Alexandra Carne-Watson, Abhishek Shastri, Arunan Saravanamuthu et al. (13 authors)

BMC Psychiatry2022-08-127 citations

10.1186/s12888-022-04193-7

Switching antipsychotic medication to reduce sexual dysfunction in people with psychosis: the REMEDY RCT

Mike Crawford, Lavanya Thana, Rachel Evans, Alexandra Carne, Lesley O’Connell et al. (20 authors)

Health Technology Assessment2020-09-018 citations

10.3310/hta24440

Interventions

Participants will be randomised on a 1:1 allocation ratio using a remote web-based randomisation system to either enhanced standard care plus a switch in antipsychotic medication or enhanced standard

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
1. Sexual behaviour measured using questions from the National Survey of Sexual Attitudes and Lifestyles (NATSAL) at baseline and 6 months 2. Researcher-rated sexual functioning measured using the Clinical Global Impression for Sexual Functioning at 6 months 3. Mental health measured using the total score on the Positive and Negative Syndrome Scale (PANSS) at baseline and 6 months 4. Side effects of medication measured using the Antipsychotic Non-Neurological Side Effects Scale (ANNSERS) at baseline and 6 months 5. Medication adherence measured using the Brief Adherence Rating Scale (BARS) at baseline and 6 months 6. Quality of life measured using the European Quality of Life-5 Dimensions (EQ-5D-5L) 40 and the Recovering Quality of Life (REQOL) questionnaire at baseline and 6 months 7. Resource use measured using the Adult Service Use Schedule (AD-SUS) at baseline and 6 months	—

Measure

Time frame

1. Sexual behaviour measured using questions from the National Survey of Sexual Attitudes and Lifestyles (NATSAL) at baseline and 6 months 2. Researcher-rated sexual functioning measured using the Clinical Global Impression for Sexual Functioning at 6 months 3. Mental health measured using the total score on the Positive and Negative Syndrome Scale (PANSS) at baseline and 6 months 4. Side effects of medication measured using the Antipsychotic Non-Neurological Side Effects Scale (ANNSERS) at baseline and 6 months 5. Medication adherence measured using the Brief Adherence Rating Scale (BARS) at baseline and 6 months 6. Quality of life measured using the European Quality of Life-5 Dimensions (EQ-5D-5L) 40 and the Recovering Quality of Life (REQOL) questionnaire at baseline and 6 months 7. Resource use measured using the Adult Service Use Schedule (AD-SUS) at baseline and 6 months

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Countries

England, United Kingdom

Outcome results

None listed