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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02751632




Registration number
NCT02751632
Ethics application status
Date submitted
12/04/2016
Date registered
26/04/2016
Date last updated
16/09/2020

Titles & IDs
Public title
The Staged Treatment in Early Psychosis Study
Scientific title
Staged Treatment in Early Psychosis (STEP): A Sequential Multistage Randomized Clinical Trial (SMART) of Interventions for Ultra High Risk (UHR) of Psychosis Patients.
Secondary ID [1] 0 0
1U01MH105258-01
Secondary ID [2] 0 0
2015.173
Universal Trial Number (UTN)
Trial acronym
STEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychotic Disorders 0 0
Personality Disorders 0 0
Clinical High Risk 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Support and Problem Solving Therapy
BEHAVIORAL - Cognitive Behavioural Case Management
Treatment: Drugs - Fluoxetine
Treatment: Drugs - Placebo
BEHAVIORAL - 3-monthly monitoring

Experimental: Step 1-Regular SPS Therapy - Support and Problem Solving Therapy delivered to all study participants over a six-week period with a minimum of three sessions.

Experimental: Responders- Monthly SPS Therapy - Participants are randomised to receive monthly Support and Problem Solving Therapy for up to 12 months.

Experimental: Responders- 3-monthly monitoring - Participants are randomised to be monitored for risk every 3 months for up to 12 months.

Experimental: Step 2- Regular SPS Therapy - 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.

Experimental: Step 2- Regular CBCM - Participants are randomised to receive regular sessions of Cognitive Behavioural Case Management, with a minimum of six sessions delivered over an 18-week period.

Experimental: Step 3- Regular CBCM + Fluoxetine - Participants are randomised to receive either Cognitive Behavioural Case Management plus an antidepressant medication for six months .

Placebo comparator: Step 3- Regular CBCM+ placebo - Participants are randomised to receive Cognitive Behavioural Case Management plus placebo medication for six months.


BEHAVIORAL: Support and Problem Solving Therapy
Support and Problem Solving Therapy involves providing participants with emotional support and helping them to resolve their problems in day-to-day life.

BEHAVIORAL: Cognitive Behavioural Case Management
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.

Treatment: Drugs: Fluoxetine
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.

Treatment: Drugs: Placebo
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.

BEHAVIORAL: 3-monthly monitoring
Study participants will be contacted on a 3-monthly basis by a study clinician who will be assessing the participant's risk.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Global Functioning Scale Score
Timepoint [1] 0 0
6 months from baseline (end of Step 2)
Secondary outcome [1] 0 0
Global Functioning Scale Score
Timepoint [1] 0 0
12 months from baseline (end of Step 3)
Secondary outcome [2] 0 0
Comprehensive Assessment of At Risk Mental State score
Timepoint [2] 0 0
12 and 24 months from baseline
Secondary outcome [3] 0 0
Comprehensive Assessment of At Risk Mental State score
Timepoint [3] 0 0
1.5, 6, 12 and 24 months from baseline
Secondary outcome [4] 0 0
Scale for Assessment of Negative Symptoms score
Timepoint [4] 0 0
1.5, 6, 12 and 24 months from baseline
Secondary outcome [5] 0 0
Comprehensive Assessment of At Risk Mental State score
Timepoint [5] 0 0
During the first 12 months from baseline.
Secondary outcome [6] 0 0
Montgomery Asberg Depression Rating Scale score
Timepoint [6] 0 0
1.5, 6, 12 and 24 months from baseline
Secondary outcome [7] 0 0
Comprehensive Assessment of At Risk Mental State score
Timepoint [7] 0 0
1.5, 6, 12 and 24 months from baseline

Eligibility
Key inclusion criteria
INCLUSION CRITERIA

* 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

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

EXCLUSION CRITERIA

* 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.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2021
Actual
Sample size
Target
340
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Headspace - Craigieburn
Recruitment hospital [2] 0 0
Headspace - Glenroy
Recruitment hospital [3] 0 0
Orygen Youth Health Clinical Program - Melbourne
Recruitment hospital [4] 0 0
Headspace - Sunshine
Recruitment hospital [5] 0 0
Headspace - Werribee
Recruitment postcode(s) [1] 0 0
3064 - Craigieburn
Recruitment postcode(s) [2] 0 0
3046 - Glenroy
Recruitment postcode(s) [3] 0 0
3052 - Melbourne
Recruitment postcode(s) [4] 0 0
3020 - Sunshine
Recruitment postcode(s) [5] 0 0
3030 - Werribee

Funding & Sponsors
Primary sponsor type
Other
Name
Orygen
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Mental Health (NIMH)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of California, Davis
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of California, San Francisco
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT02751632
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick McGorry, MD, PhD
Address 0 0
Orygen Youth Research Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02751632