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Trial record 16 of 4653 for:    Recruiting, Not yet recruiting, Available Studies | "Psychotic Disorders"

The Staged Treatment in Early Psychosis Study (STEP)

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ClinicalTrials.gov Identifier: NCT02751632
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Patrick McGorry, Orygen Youth Health Research Centre

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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Personality Disorders Behavioral: Support and Problem Solving Therapy Behavioral: Cognitive Behavioural Case Management Drug: Fluoxetine Drug: Placebo Behavioral: 3-monthly monitoring Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Other Name: SPS

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

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

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.
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.
Other Name: SPS

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.
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.
Other Name: CBCM

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

Drug: 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.
Other Name: Anti-depressant medication

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

Drug: 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.
Other Name: Inactive Medicine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Global Functioning Scale Score [ Time Frame: 12 months from baseline (end of Step 3) ]
    To test the effect of a sequential treatment approach consisting of SPS, CBCM and antidepressant medication on functioning levels of UHR patients.

  2. Comprehensive Assessment of At Risk Mental State score [ Time Frame: 12 and 24 months from baseline ]
    To test the effect of a sequential treatment approach consisting of SPS, CBCM and antidepressant medication on transition to psychotic disorder.

  3. Comprehensive Assessment of At Risk Mental State score [ Time Frame: 1.5, 6, 12 and 24 months from baseline ]
    To test the effect of a sequential treatment approach on UHR status (maintenance versus remission).

  4. Scale for Assessment of Negative Symptoms score [ Time Frame: 1.5, 6, 12 and 24 months from baseline ]
    To test the effect of a sequential treatment approach in UHR patients on level of negative psychotic symptoms.

  5. Comprehensive Assessment of At Risk Mental State score [ Time Frame: During the first 12 months from baseline. ]
    To test relapse rates (to UHR+ status) in the relapse prevention/responder arm of the trial (SPS v monitoring).

  6. Montgomery Asberg Depression Rating Scale score [ Time Frame: 1.5, 6, 12 and 24 months from baseline ]
    To test the effect of a sequential treatment approach in UHR patients on level and depressive symptoms.

  7. Comprehensive Assessment of At Risk Mental State score [ Time Frame: 1.5, 6, 12 and 24 months from baseline ]
    To test the effect of a sequential treatment approach in UHR patients on level of positive psychotic symptoms.



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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751632


Contacts
Contact: Barnaby Nelson, PhD +61 3 9342 2825 barnaby.nelson@orygen.org.au
Contact: Jessica Spark, BPsych(Hons) +61499 920 665 jessica.spark@orygen.org.au

Locations
Australia, Victoria
Headspace Not yet recruiting
Craigieburn, Victoria, Australia, 3064
Principal Investigator: Patrick McGorry, MD,PhD         
Headspace Recruiting
Glenroy, Victoria, Australia, 3046
Principal Investigator: Patrick McGorry, MD, PhD         
Orygen Youth Health Clinical Program Recruiting
Melbourne, Victoria, Australia, 3052
Principal Investigator: Patrick McGorry, MD, PhD         
Headspace Not yet recruiting
Sunshine, Victoria, Australia, 3020
Principal Investigator: Patrick McGorry, MD, PhD         
Headspace Not yet recruiting
Werribee, Victoria, Australia, 3030
Principal Investigator: Patrick McGorry, MD,PhD         
Sponsors and Collaborators
Orygen Youth Health Research Centre
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Patrick McGorry, MD, PhD Orygen Youth Research Centre

Responsible Party: Patrick McGorry, Professor Patrick McGorry, Orygen Youth Health Research Centre
ClinicalTrials.gov Identifier: NCT02751632     History of Changes
Other Study ID Numbers: 2015.173
1U01MH105258-01 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Patrick McGorry, Orygen Youth Health Research Centre:
Ultra High Risk of Psychosis
Prodrome

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Disease
Personality Disorders
Pathologic Processes
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors