Antidepressant for the prevention of depression following first-episode psychosis
- Conditions
- PsychosisMental and Behavioural DisordersUnspecified nonorganic psychosis
- Registration Number
- ISRCTN12682719
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37803384/ (added 10/10/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 452
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of new cases of depression as indicated by a Calgary Depression for Schizophrenia Scale (CDSS) score < 5 and confirmed by Mini International Neuropsychiatric Interview (MINI) in each treatment arm over the 6-month intervention phase. Measured at baseline, monthly for 6 months and at 12 months
- Secondary Outcome Measures
Name Time Method