Exclusion Criteria
The AFFINITY Trial included specific exclusion criteria to identify participants for whom fluoxetine treatment or participation in the study could present additional risks or where reliable long-term follow-up was not possible. Participants were excluded if any of the following criteria applied.
Medical History
Participants were excluded if they had a:
- History of epileptic seizures
- History of bipolar disorder
- History of drug overdose or attempted suicide
Current SSRI Treatment
Participants receiving ongoing treatment with any selective serotonin reuptake inhibitor (SSRI) were not eligible for enrolment in the trial.
Contraindications to Fluoxetine
Participants were excluded if they had an allergy or other contraindication to fluoxetine, including certain forms of hepatic, renal or electrolyte impairment.
Specific exclusion thresholds included:
- Hepatic impairment: serum alanine aminotransferase (ALT) greater than 120 U/L
- Renal impairment: creatinine greater than 180 micromol/L or estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m²
- Hyponatraemia: serum sodium below 125 mmol/L despite treatment of the underlying cause and confirmation on repeat testing
Medications That May Interact With Fluoxetine
Participants were excluded when they were taking, or were expected to require, medications that could result in a serious interaction with fluoxetine. This included:
- Proposed use of a monoamine oxidase inhibitor (MAOI) or use of an MAOI within 14 days before randomisation
- Current treatment with an antipsychotic drug (neuroleptic), pimozide, tamoxifen or tramadol, unless the patient, treating doctor and, where possible, the prescribing doctor considered it appropriate to discontinue the medication
Follow-Up Requirements
Participants needed to be available for follow-up throughout the study period. Individuals who were not expected to be available for follow-up over the following 365 days were excluded. An example included individuals without a fixed home address where this would prevent reliable long-term follow-up.
Life-Threatening Illness
Participants with a life-threatening illness that was likely to substantially reduce survival over the 365-day follow-up period were excluded. An example specified in the study protocol was advanced cancer.
Pregnancy and Breastfeeding
Women who were pregnant or breastfeeding were excluded from participation. Women of child-bearing potential were also excluded if they were not using contraception.
Participation in Other Clinical Trials
Individuals were not eligible if they were already enrolled in another interventional clinical research trial involving an investigational product, medicine or device.
Applying the Exclusion Criteria
The exclusion criteria were used alongside the AFFINITY Trial inclusion criteria to determine eligibility before randomisation. They were designed to ensure that participants met the study requirements and that factors such as medical history, potential drug interactions, safety considerations and the ability to complete follow-up were appropriately considered.
Sources and Related Study Information
These historical criteria describe trial participation requirements. Consult the registered eligibility criteria in ANZCTR for the source record. See the study protocol for methods and the study outline for the participant journey.