Psychotic DisordersPhase 3STEPNCT02751632
The Staged Treatment in Early Psychosis Study
A Phase 3 study testing Support and Problem Solving Therapy, Cognitive Behavioural Case Management and Fluoxetine in people with Psychotic Disorders and Personality Disorders, run by Orygen at 5 sites in Australia.
Trial summary
A sequential multistage randomised clinical trial (SMART) to produce evidence to guide a step-wise clinical approach for the treatment of ultra high risk patients and reduction of risk for psychosis and other deleterious clinical and/or functional outcomes. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Psychotic Disorders, Personality Disorders, Clinical High Risk
- What is being tested?
- Support and Problem Solving Therapy, Cognitive Behavioural Case Management and Fluoxetine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 5 sitesAustralia
- Study dates
- Apr 2016to May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12 -25 years (inclusive) at entry.
- Ability to speak adequate English (for assessment purposes).
- Ability to provide informed consent.
- Meeting one or more Ultra High Risk for psychosis groups as defined below:
- Group 1: Vulnerability Group
- Family history of psychosis in first degree relative OR Schizotypal Personality Disorder (as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) IV in identified patient
Show all 25Show fewer
- AND
- Drop in Functioning:
- Recency: Change in functioning occurred within last year Impact: Social and Occupational Functioning Assessment Scale (SOFAS) score at least 30% below previous level of functioning and sustained for at least one month.
- OR
- Sustained low functioning:
- Recency: For the past 12 months or longer Impact: SOFAS score of 50 or less.
- Group 2: Attenuated Psychotic Symptoms Group 2a) Subthreshold intensity:
- Intensity: Global Rating Scale Score of 3-5 on Unusual Thought Content subscale, 3-5 on Non-Bizarre Ideas subscale, 3-4 on Perceptual Abnormalities subscale and/or 4-5 on Disorganised Speech subscales of the Comprehensive Assessment of At Risk Mental States (CAARMS).
- Frequency: Frequency Scale Score of 3-6 on Unusual Thought Content, Non-Bizarre Ideas, Perceptual Abnormalities and/or Disorganised Speech subscales of the CAARMS
- Duration: symptoms present for at least one week
- Recency: symptoms present in past year
- 2b) Subthreshold frequency:
- Intensity: Global Rating Scale Score of 6 on Unusual Thought Content subscale, 6 on Non-Bizarre Ideas subscale, 5-6 on Perceptual Abnormalities subscale and/or 6 on Disorganised Speech subscales of the CAARMS
- Frequency: Frequency Scale Score of 3 on Unusual Thought Content, Non-Bizarre Ideas, Perceptual Abnormalities and/or Disorganised Speech subscales of the CAARMS
- Recency: symptoms present in past year
- Group 3: Brief Limited Intermittent Psychotic Symptoms Intensity: Global Rating Scale Score of 6 on Unusual Thought Content subscale, 6 on Non-Bizarre Ideas subscale, 5 or 6 on Perceptual Abnormalities subscale and/or 6 on Disorganised Speech subscales of the CAARMS
- Frequency: Frequency Scale Score of 4-6 on Unusual Thought Content, Non-Bizarre Ideas, Perceptual Abnormalities and/or Disorganised Speech subscales
- Duration: Symptoms present for less than one week and spontaneously remit on every occasion.
- Recency: symptoms present in past year
Who cannot join
- Past history of a psychotic episode of one week or longer, whether treated with antipsychotic medications or not.
- Attenuated psychotic symptoms only present during acute intoxication.
- Organic brain disease known to cause psychotic symptoms, e.g. temporal lobe epilepsy.
- Any metabolic, endocrine or other physical illness, e.g. thyroid disease, with known neuropsychiatric consequences.
- Diagnosis of a serious developmental disorder, e.g. Severe Autism Spectrum Disorder.
- Premorbid Intelligence Quotient (IQ) <70 and a documented history of developmental delay or intellectual disability.
- Current or previous SCID diagnosis of Bipolar I.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Headspace
Craigieburn, Victoria, 3064
Headspace
Glenroy, Victoria, 3046
Orygen Youth Health Clinical Program
Melbourne, Victoria, 3052
Headspace
Sunshine, Victoria, 3020
Headspace
Werribee, Victoria, 3030
About this study
Official title: Staged Treatment in Early Psychosis (STEP): A Sequential Multistage Randomized Clinical Trial (SMART) of Interventions for Ultra High Risk (UHR) of Psychosis Patients.
A sequential multistage randomised clinical trial (SMART) to produce evidence to guide a step-wise clinical approach for the treatment of ultra high risk patients and reduction of risk for psychosis and other deleterious clinical and/or functional outcomes.
Read the detailed description
The study treatment sequence involves three stages, which are referred to as steps:
Step 1- Support and Problem Solving (SPS)
All trial participants receive SPS treatment in Step 1. Step 1 involves attending weekly-fortnightly SPS sessions over a six week period and the Week 4 and 6 visits will also include an interview with research staff who will assess the symptoms and mental state of participants. These assessments will enable research staff to determine whether the therapy has been effective in improving the participant's symptoms.
Depending on how they respond to the six-week period of treatment in Step 1, participants are randomly assigned to a new treatment arm at the end of Step 1 as detailed below:
Participants who improve with the SPS treatment they receive during Step 1, will be randomised to either monthly SPS treatment for up to one year OR to three-monthly appointments (Month 3, 6, 9 and 12) to monitor their mental state.
Participants who do not improve with the SPS treatment they receive during Step 1 will be randomised to continue treatment in one of two groups in Step 2 as outlined below.
Step 2- Support and Problem Solving (SPS) OR Cognitive Behavioural Case Management (CBCM)
In Step 2, participants will receive either SPS OR Cognitive Behavioural Case Management for a period of 18 weeks. Participants will be interviewed at two time points across this step so that research staff can assess whether the therapy has helped improve their symptoms.
Participants who improve with the treatment they receive in Step 2 will be randomised to receive either monthly SPS for a further six months OR to three-monthly appointments (Month 9, 12) to monitor their mental state.
Participants who do not improve with the treatment they receive in Step 2 will be randomised to one of two treatment groups in Step 3 as outlined below.
Step 3 Cognitive Behavioural Case Management plus antidepressant medication OR Cognitive Behavioural Case Management plus placebo medication.
Participants assigned to one of the two treatment groups in Step 3 will receive the corresponding treatment over a six-month period. Both treatment groups will involve: regular CBCM sessions; regular review by a clinician, as well as the assigned medication.
Depending on which group participants are randomised to, they may either receive antidepressant medication OR placebo medication.
If a participant does not improve, or deteriorates by 12 weeks into Step 3, they will be given a choice to: continue with the treatment regime already assigned to them; increase the dosage of their medication, or start a new medication. Upon their choosing, the medication at this stage may either be an antipsychotic medication OR omega-3 fatty acids ('fish oil'), taken in addition to the other treatment components of this step.
The intervention aspect of this study covers a 12 month period. After completion of this intervention period, participants will also be invited to take part in two separate follow-up interviews with research staff, at both 18 months and 24 months.
US Pilot Study:
The University of California, Davis will oversee a pilot study for the implementation of the STEP model in the Early Diagnosis and Preventative Treatment (EDAPT) clinic at UC Davis in Sacramento, California. After giving informed consent, CHR patients and their families entering treatment in the EDAPT program will be offered participation in the staged intervention trial. CHR participants will be characterized with the Structured Interview for Prodromal Syndromes (SIPS) following standard procedures in the U.S. Similarly, defining risk based on 3 core syndromes that span analogous dimensions of symptom severity from attenuated to psychotic, a recent meta-analysis demonstrates that the SIPS reliably identifies youth at clinical high risk for psychosis at a rate comparable to the CAARMS, which is used in the main trial being conducted in the Orygen parent study. Thirty patients will be enrolled and followed through the protocol until 24 month follow up.The team will also harmonize CBT practice with the CBCM model used at Orygen. All outcome measures will parallel those used in the parent study at Orygen. UC Davis research staff will complete clinical and outcome assessments with CHR participants at study entry, 6, 12 and 24 months. Data analysis will also parallel those conducted in the parent study. However, the key measures will be acceptance and retention in the staged treatment.
US Focus Groups:
The University of California, San Francisco will design, conduct and analyze output from a series of focus groups to gather input from stakeholders regarding translation of STEP trial interventions to the US healthcare system. This will include identifying barriers and solutions to implementation of STEP trial interventions in the US context for CHR patients. Groups will include CA county mental health leadership, private insurance mental health leadership, mental health leadership at DHHS and the Center for Medicare/Medicaid Services, leadership from community-based organizations currently providing services for this population, consumers, and family members.
- Being tested
- Support and Problem Solving Therapy, Cognitive Behavioural Case Management, Fluoxetine, Placebo, 3-monthly monitoring
- Keywords
- Ultra High Risk of Psychosis, Prodrome, Clinical High Risk of Psychosis
- Medical subject headings
- Psychotic Disorders, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support and Problem Solving TherapyBehavioural
Also called SPS
Support and Problem Solving Therapy involves providing participants with emotional support and helping them to resolve their problems in day-to-day life.
Cognitive Behavioural Case ManagementBehavioural
Also called CBCM
CBCM has a number of different elements including: strategies to help with stress management; therapy that targets thinking and behavioural patterns; practical assistance, as well as yoga and mindfulness.
FluoxetineDrug
Also called Anti-depressant medication
Participants will commence on 1 capsule of fluoxetine 20 mg, to be taken in the morning. The medication can be increased to fluoxetine 40 mg daily if there has been a poor clinical response after the first 6 weeks of treatment.
PlaceboDrug
Also called Inactive Medicine
Participants will commence on 1 capsule of the placebo pill, to be taken in the morning. The medication can be increased to 2 placebo capsules if there has been a poor clinical response after the first 6 weeks of treatment.
3-monthly monitoringBehavioural
Study participants will be contacted on a 3-monthly basis by a study clinician who will be assessing the participant's risk.
| Study group | Role | What they receive |
|---|---|---|
| Step 1-Regular SPS Therapy | Experimental | Support and Problem Solving Therapy delivered to all study participants over a six-week period with a minimum of three sessions. Receives: Behavioral: Support and Problem Solving Therapy |
| Responders- Monthly SPS Therapy | Experimental | Participants are randomised to receive monthly Support and Problem Solving Therapy for up to 12 months. Receives: Behavioral: Support and Problem Solving Therapy |
| Responders- 3-monthly monitoring | Experimental | Participants are randomised to be monitored for risk every 3 months for up to 12 months. Receives: Behavioral: 3-monthly monitoring |
| Step 2- Regular SPS Therapy | Experimental | Participants are randomised to receive regular sessions of Support and Problem Solving Therapy, with a minimum of six sessions delivered over an 18-week period. Receives: Behavioral: Support and Problem Solving Therapy |
| Step 2- Regular CBCM | Experimental | Participants are randomised to receive regular sessions of Cognitive Behavioural Case Management, with a minimum of six sessions delivered over an 18-week period. Receives: Behavioral: Cognitive Behavioural Case Management |
| Step 3- Regular CBCM + Fluoxetine | Experimental | Participants are randomised to receive either Cognitive Behavioural Case Management plus an antidepressant medication for six months . Receives: Behavioral: Cognitive Behavioural Case Management; Drug: Fluoxetine |
| Step 3- Regular CBCM+ placebo | Placebo comparator | Participants are randomised to receive Cognitive Behavioural Case Management plus placebo medication for six months. Receives: Behavioral: Cognitive Behavioural Case Management; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Functioning Scale Score
To test the effect of a sequential treatment approach consisting of SPS/SPS and SPS/CBCM on functioning levels of UHR patients.
Measured: 6 months from baseline (end of Step 2)
Secondary outcomes (7)
Global Functioning Scale Score
To test the effect of a sequential treatment approach consisting of SPS, CBCM and antidepressant medication on functioning levels of UHR patients.
Measured: 12 months from baseline (end of Step 3)
Comprehensive Assessment of At Risk Mental State score
To test the effect of a sequential treatment approach consisting of SPS, CBCM and antidepressant medication on transition to psychotic disorder.
Measured: 12 and 24 months from baseline
Comprehensive Assessment of At Risk Mental State score
To test the effect of a sequential treatment approach on UHR status (maintenance versus remission).
Measured: 1.5, 6, 12 and 24 months from baseline
Scale for Assessment of Negative Symptoms score
To test the effect of a sequential treatment approach in UHR patients on level of negative psychotic symptoms.
Measured: 1.5, 6, 12 and 24 months from baseline
Comprehensive Assessment of At Risk Mental State score
To test relapse rates (to UHR+ status) in the relapse prevention/responder arm of the trial (SPS v monitoring).
Measured: During the first 12 months from baseline.
Montgomery Asberg Depression Rating Scale score
To test the effect of a sequential treatment approach in UHR patients on level and depressive symptoms.
Measured: 1.5, 6, 12 and 24 months from baseline
Comprehensive Assessment of At Risk Mental State score
To test the effect of a sequential treatment approach in UHR patients on level of positive psychotic symptoms.
Measured: 1.5, 6, 12 and 24 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2019
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orygen
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, Davis, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Patrick McGorry, MD, PhD, Principal investigator, Orygen Youth Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751632
- Sponsor's protocol ID
- 2015.173
- Other IDs
- 1U01MH105258-01
- Acronym
- STEP
- Status last verified
- Sep 2025
- First submitted
- 12 Apr 2016
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
McGorry PD, Mei C, Amminger GP, Yuen HP, Kerr M, Spark J, Wallis N, Polari A, Baird S, Buccilli K, Dempsey SA, Ferguson N, Formica M, Krcmar M, Quinn AL, Mebrahtu Y, Ruslins A, Street R, Wannan C, Dixon L, Carter C, Loewy R, Niendam TA, Shumway M, Nelson B. A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis: The Staged Treatment in Early Psychosis (STEP) Sequential Multiple Assignment Randomized Trial. JAMA Psychiatry. 2023 Sep 1;80(9):875-885. doi: 10.1001/jamapsychiatry.2023.1947.
PubMed 37378974
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staged Treatment in Early Psychosis (STEP): A Sequential Multistage Randomized Clinical Trial (SMART) of Interventions for Ultra High Risk (UHR) of Psychosis Patients.
- ClinicalTrials.gov ID
- NCT02751632
- Acronym / sponsor ID
- STEP / 2015.173
- Keywords
- Ultra High Risk of Psychosis, Prodrome, Clinical High Risk of Psychosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- OrygenUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, Davis, University of California, San Francisco
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A sequential multistage randomised clinical trial (SMART) to produce evidence to guide a step-wise clinical approach for the treatment of ultra high risk patients and reduction of risk for psychosis and other deleterious clinical and/or functional outcomes.
Detailed description
The study treatment sequence involves three stages, which are referred to as steps:
Step 1- Support and Problem Solving (SPS)
All trial participants receive SPS treatment in Step 1. Step 1 involves attending weekly-fortnightly SPS sessions over a six week period and the Week 4 and 6 visits will also include an interview with research staff who will assess the symptoms and mental state of participants. These assessments will enable research staff to determine whether the therapy has been effective in improving the participant's symptoms.
Depending on how they respond to the six-week period of treatment in Step 1, participants are randomly assigned to a new treatment arm at the end of Step 1 as detailed below:
Participants who improve with the SPS treatment they receive during Step 1, will be randomised to either monthly SPS treatment for up to one year OR to three-monthly appointments (Month 3, 6, 9 and 12) to monitor their mental state.
Participants who do not improve with the SPS treatment they receive during Step 1 will be randomised to continue treatment in one of two groups in Step 2 as outlined below.
Step 2- Support and Problem Solving (SPS) OR Cognitive Behavioural Case Management (CBCM)
In Step 2, participants will receive either SPS OR Cognitive Behavioural Case Management for a period of 18 weeks. Participants will be interviewed at two time points across this step so that research staff can assess whether the therapy has helped improve their symptoms.
Participants who improve with the treatment they receive in Step 2 will be randomised to receive either monthly SPS for a further six months OR to three-monthly appointments (Month 9, 12) to monitor their mental state.
Participants who do not improve with the treatment they receive in Step 2 will be randomised to one of two treatment groups in Step 3 as outlined below.
Step 3 Cognitive Behavioural Case Management plus antidepressant medication OR Cognitive Behavioural Case Management plus placebo medication.
Participants assigned to one of the two treatment groups in Step 3 will receive the corresponding treatment over a six-month period. Both treatment groups will involve: regular CBCM sessions; regular review by a clinician, as well as the assigned medication.
Depending on which group participants are randomised to, they may either receive antidepressant medication OR placebo medication.
If a participant does not improve, or deteriorates by 12 weeks into Step 3, they will be given a choice to: continue with the treatment regime already assigned to them; increase the dosage of their medication, or start a new medication. Upon their choosing, the medication at this stage may either be an antipsychotic medication OR omega-3 fatty acids ('fish oil'), taken in addition to the other treatment components of this step.
The intervention aspect of this study covers a 12 month period. After completion of this intervention period, participants will also be invited to take part in two separate follow-up interviews with research staff, at both 18 months and 24 months.
US Pilot Study:
The University of California, Davis will oversee a pilot study for the implementation of the STEP model in the Early Diagnosis and Preventative Treatment (EDAPT) clinic at UC Davis in Sacramento, California. After giving informed consent, CHR patients and their families entering treatment in the EDAPT program will be offered participation in the staged intervention trial. CHR participants will be characterized with the Structured Interview for Prodromal Syndromes (SIPS) following standard procedures in the U.S. Similarly, defining risk based on 3 core syndromes that span analogous dimensions of symptom severity from attenuated to psychotic, a recent meta-analysis demonstrates that the SIPS reliably identifies youth at clinical high risk for psychosis at a rate comparable to the CAARMS, which is used in the main trial being conducted in the Orygen parent study. Thirty patients will be enrolled and followed through the protocol until 24 month follow up.The team will also harmonize CBT practice with the CBCM model used at Orygen. All outcome measures will parallel those used in the parent study at Orygen. UC Davis research staff will complete clinical and outcome assessments with CHR participants at study entry, 6, 12 and 24 months. Data analysis will also parallel those conducted in the parent study. However, the key measures will be acceptance and retention in the staged treatment.
US Focus Groups:
The University of California, San Francisco will design, conduct and analyze output from a series of focus groups to gather input from stakeholders regarding translation of STEP trial interventions to the US healthcare system. This will include identifying barriers and solutions to implementation of STEP trial interventions in the US context for CHR patients. Groups will include CA county mental health leadership, private insurance mental health leadership, mental health leadership at DHHS and the Center for Medicare/Medicaid Services, leadership from community-based organizations currently providing services for this population, consumers, and family members.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Step 1-Regular SPS Therapy | Experimental | Behavioral: Support and Problem Solving TherapySupport and Problem Solving Therapy delivered to all study participants over a six-week period with a minimum of three sessions. |
| Responders- Monthly SPS Therapy | Experimental | Behavioral: Support and Problem Solving TherapyParticipants are randomised to receive monthly Support and Problem Solving Therapy for up to 12 months. |
| Responders- 3-monthly monitoring | Experimental | Behavioral: 3-monthly monitoringParticipants are randomised to be monitored for risk every 3 months for up to 12 months. |
| Step 2- Regular SPS Therapy | Experimental | Behavioral: Support and Problem Solving TherapyParticipants are randomised to receive regular sessions of Support and Problem Solving Therapy, with a minimum of six sessions delivered over an 18-week period. |
| Step 2- Regular CBCM | Experimental | Behavioral: Cognitive Behavioural Case ManagementParticipants are randomised to receive regular sessions of Cognitive Behavioural Case Management, with a minimum of six sessions delivered over an 18-week period. |
| Step 3- Regular CBCM + Fluoxetine | Experimental | Behavioral: Cognitive Behavioural Case Management, Drug: FluoxetineParticipants are randomised to receive either Cognitive Behavioural Case Management plus an antidepressant medication for six months . |
| Step 3- Regular CBCM+ placebo | Placebo comparator | Behavioral: Cognitive Behavioural Case Management, Drug: PlaceboParticipants are randomised to receive Cognitive Behavioural Case Management plus placebo medication for six months. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (25 listed)
- Age 12 -25 years (inclusive) at entry.
- Ability to speak adequate English (for assessment purposes).
- Ability to provide informed consent.
- Meeting one or more Ultra High Risk for psychosis groups as defined below:
- Group 1: Vulnerability Group
Key exclusion criteria (7 listed)
- Past history of a psychotic episode of one week or longer, whether treated with antipsychotic medications or not.
- Attenuated psychotic symptoms only present during acute intoxication.
- Organic brain disease known to cause psychotic symptoms, e.g. temporal lobe epilepsy.
- Any metabolic, endocrine or other physical illness, e.g. thyroid disease, with known neuropsychiatric consequences.
- Diagnosis of a serious developmental disorder, e.g. Severe Autism Spectrum Disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Support and Problem Solving TherapyAlso: SPSSupport and Problem Solving Therapy involves providing participants with emotional support and helping them to resolve their problems in day-to-day life. | Behavioural | Responders- Monthly SPS Therapy, Step 1-Regular SPS Therapy, Step 2- Regular SPS Therapy |
| Cognitive Behavioural Case ManagementAlso: CBCMCBCM has a number of different elements including: strategies to help with stress management; therapy that targets thinking and behavioural patterns; practical assistance, as well as yoga and mindfulness. | Behavioural | Step 2- Regular CBCM, Step 3- Regular CBCM + Fluoxetine, Step 3- Regular CBCM+ placebo |
| FluoxetineAlso: Anti-depressant medicationParticipants will commence on 1 capsule of fluoxetine 20 mg, to be taken in the morning. The medication can be increased to fluoxetine 40 mg daily if there has been a poor clinical response after the first 6 weeks of treatment. | Drug | Step 3- Regular CBCM + Fluoxetine |
| PlaceboAlso: Inactive MedicineParticipants will commence on 1 capsule of the placebo pill, to be taken in the morning. The medication can be increased to 2 placebo capsules if there has been a poor clinical response after the first 6 weeks of treatment. | Drug | Step 3- Regular CBCM+ placebo |
| 3-monthly monitoringStudy participants will be contacted on a 3-monthly basis by a study clinician who will be assessing the participant's risk. | Behavioural | Responders- 3-monthly monitoring |
Primary outcome
Global Functioning Scale Score
Time frame: 6 months from baseline (end of Step 2)
To test the effect of a sequential treatment approach consisting of SPS/SPS and SPS/CBCM on functioning levels of UHR patients.
7 secondary outcomes
Global Functioning Scale Score
Time frame: 12 months from baseline (end of Step 3)
Comprehensive Assessment of At Risk Mental State score
Time frame: 12 and 24 months from baseline
Comprehensive Assessment of At Risk Mental State score
Time frame: 1.5, 6, 12 and 24 months from baseline
Scale for Assessment of Negative Symptoms score
Time frame: 1.5, 6, 12 and 24 months from baseline
Comprehensive Assessment of At Risk Mental State score
Time frame: During the first 12 months from baseline.
Montgomery Asberg Depression Rating Scale score
Time frame: 1.5, 6, 12 and 24 months from baseline
Comprehensive Assessment of At Risk Mental State score
Time frame: 1.5, 6, 12 and 24 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 37378974McGorry PD, Mei C, Amminger GP, Yuen HP, Kerr M, Spark J, Wallis N, Polari A, Baird S, Buccilli K, Dempsey SA, Ferguson N, Formica M, Krcmar M, Quinn AL, Mebrahtu Y, Ruslins A, Street R, Wannan C, Dixon L, Carter C, Loewy R, Niendam TA, Shumway M, Nelson B. A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis: The Staged Treatment in Early Psychosis (STEP) Sequential Multiple Assignment Randomized Trial. JAMA Psychiatry. 2023 Sep 1;80(9):875-885. doi: 10.1001/jamapsychiatry.2023.1947.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick McGorry, MD, PhD principal investigator
Orygen Youth Research Centre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Support and Problem Solving Therapy, Cognitive Behavioural Case Management and Fluoxetine in people with Psychotic Disorders and Personality Disorders, run by Orygen at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Functioning Scale Score (time frame: 6 months from baseline (end of Step 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02751632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.