ISRCTN12682719进行中（未招募）未知
Antidepressant for the prevention of DEPression following first-episode Psychosis: the ADEPP trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 452
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37803384/ (added 10/10/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 20/03/2023:
- •1. Diagnosis of first-episode psychosis (FEP)
- •2. Within 12 months of initial treatment for FEP (as defined by onset of care provision by an Early Intervention Team)
- •3. Positive and Negative Syndrome Scale (PANSS) individual positive item scores all =4
- •4. Sufficiently recovered from acute psychotic episode with capacity to consent
- •5. Males and females aged 18-65 years
- •6. Currently prescribed antipsychotic medication at stable dose.
- •7. Female participants must be willing to use one form of highly effective contraception
- •Previous inclusion criteria:
- •1. Diagnosis of first-episode psychosis (FEP)
- •2. Within 3 months of initial treatment for FEP (as defined by onset of care provision by an Early Intervention Team)
- •3. Positive and Negative Syndrome Scale (PANSS) individual positive item scores all =4
- •4. Sufficiently recovered from acute psychotic episode with capacity to consent
- •5. Males and females aged 18-35 years
- •6. Currently prescribed antipsychotic medication at stable dose.
- •7. Female participants must be willing to use one form of highly effective contraception
排除标准
- •Current exclusion criteria as of 20/03/2023:
- •1. Current moderate or severe depression (as indicated by a Calgary Depression for Schizophrenia Scale (CDSS) score of > 7)
- •2. Currently prescribed antidepressant medication (or within 2 weeks of stopping if a Monoamine Oxidase Inhibitor)
- •3. Previous history of mania
- •4. Contraindications to selective serotonin reuptake inhibitors (SSRI) antidepressant treatment (e.g. recurrent thrombotic illness, previous adverse reaction, confirmed pregnancy, although risk in pregnancy is low, prescribed pimozide)
- •5. Serious medical or neurological illness (as identified by the treating consultant psychiatrist)
- •6. Hypersensitivity to the active substance or any of the excipients or placebo
- •7. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs)
- •8. Patient with any other systemic dysfunction (e.g. gastrointestinal, renal, respiratory, cardiovascular, neurological or psychiatric) or significant disorder which, in the opinion of the investigator would jeopardize the safety of the patient by taking part in the trial
- •9. Electrocardiogram (ECG): QTc interval >450 as measured in the last 12 months
- •10. Aged below 18 years
- •11. Aged over 65 years
- •12. Female participants that do not agree to follow the protocol contraception requirements
- •Previous exclusion criteria:
- •1. Current moderate or severe depression (as indicated by a Calgary Depression for Schizophrenia Scale (CDSS) score of > 7)
- •2. Currently prescribed antidepressant medication (or within 2 weeks of stopping if a Monoamine Oxidase Inhibitor)
- •3. Previous history of mania
- •4. Contraindications to selective serotonin reuptake inhibitors (SSRI) antidepressant treatment (e.g. recurrent thrombotic illness, previous adverse reaction, confirmed pregnancy, although risk in pregnancy is low, prescribed pimozide)
- •5. Serious medical or neurological illness (as identified by the treating consultant psychiatrist)
- •6. Hypersensitivity to the active substance or any of the excipients or placebo
- •7. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs)
- •8. Patient with any other systemic dysfunction (e.g. gastrointestinal, renal, respiratory, cardiovascular, neurological or psychiatric) or significant disorder which, in the opinion of the investigator would jeopardize the safety of the patient by taking part in the trial
- •9. Electrocardiogram (ECG): QTc interval >450 as measured in the last 12 months
- •10. Aged below 18 years
- •11. Aged over 35 years
- •12. Female participants that do not agree to follow the protocol contraception requirements
研究者
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