Table 3.
Ongoing trials in CHR-P individuals.
| Trial title; ClinicalTrials.gov Identifier | Population (age); instrument | Trial arms | Allocation and masking | Duration | Sample size | Primary outcome |
|---|---|---|---|---|---|---|
| The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT). NCT02357849 | CHR-P (12-25); SIPS | 1. Fluoxetine; 2. aripiprazole | Randomized (participant, care provider, investigator outcomes assessor) | 24 weeks | 48 | Time to either all-cause-discontinuation or need to add another psychotropic agent |
| Multimodal Prevention of Psychosis - Investigating Efficacy of N-Acetylcysteine and Psychotherapy in CHR-Patients (ESPRIT-B1). NCT03149107 | CHR-P (18-40); SIPS or SPI-A | 1. Integrated Preventive Psychological Intervention plus N-Acetylcysteine; 2. Psychological stress management and N-Acetylcysteine; 3. Integrated Preventive Psychological Intervention and placebo; 4. Psychological stress management and placebo | Randomized (participant, investigator, outcomes assessor) | 6 months | 200 | Transition to psychosis |
| Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis. NCT02047539 | CHR-P (19-35); SIPS | 1. Aspirin (2-Acetoxybenzoic acid); 2. placebo | Randomized (participant, care provider, investigator outcomes assessor) | 12 weeks(a) | 40 | Symptoms improvement |
| Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe (PURPOSE). NCT02597439 | CHR-P (13-20); CAARMS | 1. Omega-3 fatty acids; 2. placebo | Randomized (participant, care provider, investigator) | 6 months | 220 | Transition to psychosis |
| Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis (FOCUS). NCT02098408 | CHR-P (18-40); CAARMS | 1. Standard treatment + cognitive remediation; 2. standard treatment | Randomized (investigator, outcomes assessor) | 6 months | 126 | Cognitive functioning |
| Cognitive Behavioral Social Skills Training for Youth at Risk of Psychosis. NCT02234258 | CHR-P (14-30); SIPS | 1. Cognitive behavioral social skills; 2. psychoeducation | Randomized (outcomes assessor) | 18 weeks | 225 | Social functioning |
| Decreasing Risk of Psychosis by Sulforaphane (DROPS Trial). NCT03932136 | CHR-P (15-45); SIPS | 1. Sulforaphane; 2. placebo | Randomized (participant, care provider, investigator, outcomes Assessor) | 52 weeks | 300 | Transition to psychosis |
| Targeted Cognitive Training in Clinical High Risk (CHR) for Psychosis. NCT02404194 | CHR-P (15-30); SIPS | 1. Targeted cognitive training; 2. computer game | Radomized (participant, investigator, outcomes assessor) | 10 weeks | 76 | Cognitive functioning |
| Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States (NAYAB). NCT02569307 | CHR-P (16-35); CAARMS | 1. Minocycline; 2. omega-3 fatty acids; 3. treatment as usual | Randomized (participant, care provider, investigator) | 6 months | 320 | Transition to psychosis |
| The Staged Treatment in Early Psychosis Study (STEP). NCT02751632 | CHR-P (15-25); CAARMS | staged treatment: 1. support and problem solving therapy; 2. cognitive behavioural case management; 3. cognitive behavioural case management plus fluoxetine; 4. cognitive behavioural case management plus placebo | Randomized (participant, investigator, outcomes assessor) | up to 12 months | 340 | Global functioning |
| Exercise and Markers of Medial Temporal Health in Youth at Ultra High-risk for Psychosis. NCT02155699 | CHR-P (16-24); SIPS | 1. Exercise 1; 2. exercise 2; 3. waiting list | Randomized (outcomes assessor) | 3 months | 45 | Brain volume |
| Glutamate Reducing Interventions in Schizophrenia. NCT03321617 | CHR-P (18-30); NA | 1. pomaglumetad methionil 40 mg, 2. pomaglumetad methionil 80 mg, 3. pomaglumetad methionil 120 mg, 4. pomaglumetad methionil 160 mg | Randomized (participant, investigator, outcomes assessor) | 2 weeks | 50 | Cerebral blood volume |
| Transcranial Direct Current Stimulation Coupled With Virtual Rehabilitation for Negative Symptoms in At-Risk Youth. NCT02951208 | CHR-P (16-30); SIPS | 1. Active Transcranial Direct Current Stimulation Coupled With Virtual Rehabilitation; 2. sham conditions | Randomized (participant, care provider, investigator outcomes assessor) | 4 weeks | 22 | Symptoms improvement |
| Neurofeedback Processing Speed Training to Improve Social Functioning in Teenagers and Young Adults at Clinical High Risk for Psychosis. NCT03447548 | CHR-P (12-25); SIPS | 1. Neurofeedback processing speed training, 2. control | Radomized (participant, outcomes assessor) | NA | 105 | Cognitive functioning |
| A Phase II Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 52-week Treatment Period as an Early Intervention in Patients With Attenuated Psychosis Syndrome. NCT03230097 | DSM-5-APS (16-30); DSM-5 | 1. BI 409306; 2. placebo | Randomized (participant, investigator) | 52 weeks | 300 | Time to remission |
(a)not clear.