The Staged Treatment in Early Psychosis Study

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Study coordinator
Name - Tyler Lesh
Email - talesh@ucdavis.edu
Phone - 9167347174

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 12 to 25 years old
Gender:
Any
Healthy Volunteers: No
Keywords: psychosis, early psychosis, early intervention in psychosis, high risk psychosis
Type: Behavioral study, Phase 3
Target:
30 Participants
Investigator:
Description
This study will investigate the most effective way of treating young people at risk of developing a psychotic disorder. We do not yet know what the most effective type of treatment is or the best sequence of treatments.

We would like to test the effect of a sequential treatment approach for at-risk young people. This means giving them a sequence of three treatments, depending on whether the young people have a good response to each stage of treatment.

The study will measure whether or not the treatment sequence was effective by:
-whether the treatments improved functioning levels and psychiatric symptoms
-whether or not they prevent or delay some young people transitioning to psychosis
-whether they help diminish some young people’s at-risk status.

The results of this study will assist with providing the best possible care in the future for young people who may be at risk of developing a psychotic disorder. It may also help us understand why some people’s symptoms and functioning get worse over time and why other people’s improve.

Medications, drugs and devices have to be approved for use by the FDA. Fluoxetine is approved by the US Food and Drug Administration to treat depression. However, it is not approved to treat risk for psychosis. Therefore, its use in this study is considered to be experimental. This study will help determine if fluoxetine is an effective treatment for risk for psychosis.
The research has been initiated by the study doctor, Cameron Carter, and is funded by a research grant from the US National Institute of Health (NIH).
This study requires

If you are determined to be eligible for the study, there will also be some physical measurements taken at this visit. The initial screening assessment will take between one and three hours depending on which of these assessments you give consent to. The screening assessment can take place over a few sessions to meet your preferences.

During Step 1, you will receive a psychological intervention called “Support and Problem Solving” (SPS) over a six-week period. Support and Problem Solving involves a therapist providing you with emotional support, and helping you to resolve problems with your day-to-day life. You will attend multiple SPS sessions (each approximately 30-50 minutes in duration) during this study step. The number of SPS sessions you receive will vary depending on your needs and what your clinician feels is appropriate for you.

If your symptoms do improve in response to Step 1, you will be randomly allocated to one of two treatment groups:

EITHER (1) Monthly Support and Problem Solving sessions for up to one year, with follow-up research assessments at Month 3, Month 6, Month 9 and Month 12. OR (2) Three-monthly monitoring by research study staff i.e. research study staff will interview you in order to assess your mental state, with follow-up research assessments at Month 3, Month 6, Month 9 and Month 12.

If your symptoms do not improve in response to Step 1, you will continue through to the second step of this study, Step 2.

Step 2

If you continue through to Step 2, you will be randomly allocated to one of two treatment groups:

EITHER (1) Support and Problem Solving (the same therapy you received during Step 1). OR (2) Cognitive Behavioral Case Management (CBCM).

Cognitive Behavioral Case Management has a number of different elements, including strategies to help you manage stress, therapy that targets thinking and behavioral patterns, practical assistance, as well as yoga and mindfulness.

If your symptoms do improve in response to the treatment you received during Step 2, you will be randomly assigned to one of two treatment groups:

EITHER (1) Monthly Support and Problem Solving sessions for a further six months. OR (2) Three-monthly monitoring by research study staff, i.e. research study staff will interview you to assess your mental state every three months for a further six months.

If your symptoms do not improve in response to the treatment you received during Step 2, you will continue through to the third step of this study, Step 3.

Step 3

If you continue through to Step 3, you will first have a blood sample collected for clinical safety testing to confirm that it is safe for you to proceed with medication. Where applicable, female participants might also need to have a blood sample taken for a pregnancy test before they can start this study step.

Once the tests confirm it is safe for you to proceed with Step 3, you will be randomized to one of two treatment groups:

EITHER (1) Cognitive Behavioral Case Management plus an antidepressant medication (fluoxetine). OR (2) Cognitive Behavioral Case Management plus a placebo medication.

The antidepressant medication will be fluoxetine (20-40mg/day), to be taken each morning with fluid (20mg = one capsule). A placebo is a capsule that looks like the study treatment but which does not contain any active ingredients.

If your symptoms do not improve or deteriorate by 12 weeks into Step 3, you will be given a choice of one of the following:

  • Continuing with your study treatment as is;
  • Increasing the dosage to 40 mg fluoxetine/placebo if this has not already been done;
  • Starting an antipsychotic medication in addition to the fluoxetine/placebo (you and the study doctor will discuss which medication might work best for you) or;
  • Starting omega-3 fatty acids (‘fish oil’, 3 capsules daily, 3.0 g/day of marine fish oil) in addition to the fluoxetine/placebo. Fish oil will be administered by the study doctor at no cost to you.
Who can participate

Inclusion criteria:

  • Male and female participants aged between 12 and 30 (inclusive) who meet “ultra high risk” for psychosis criteria at entry to services at the EDAPT clinic as determined using the Structured Interview for Prodromal Symptoms (SIPS)(162).
  • A participant will be considered eligible for inclusion in this study only if all of the following criteria apply:

  • Age 12 – 30 years (inclusive) at entry

  • Ability to speak adequate English (for assessment purposes)
  • Ability to provide informed consent. Where participants are minors (i.e. have not reached the age of eighteen), consent will also be obtained from one of the participant’s parents or legal guardian. Additionally minors will be asked to read and sign a separate assent document written in language more age-appropriate language. It will be the treating doctor’s decision made in consultation with the investigator to determine whether a participant who is a mature minor has the capacity and competence to consent to the study.
  • Meeting one or more UHR for psychosis groups: Group 1: Genetic Risk and Deterioration Syndrome (GRDS) Family history of psychosis in first degree relative OR Schizotypal Personality Disorder (as defined by DSM V) in identified patient AND Change in functioning occurred within last year. SOFAS score at least 30% below previous level of functioning (compared to 12 months ago) and sustained for at least one month. Group 2: Attenuated Positive Symptom Syndrome (APSS) Presence of recent attenuated positive symptoms of sufficient severity and frequency. One or more of the P1-P5 scales of the SOPS must be 3-5 AND a) Symptoms started in the past year or rate one point higher than 12 months ago b) Symptoms occur at the current intensity level at an average frequency of at least once per week in the past month Group 3: Brief Intermittent Psychotic Syndrome (BIPS) Presence of frankly psychotic symptoms that are recent, very brief, and do not meet the frequency/duration criteria of a current psychotic syndrome. One or more of the P1-P5 scales of the SOPS must be a 6 AND a) Symptoms must have begun in the past 3 months b) Symptoms only present at an occasional/transient rate, for at least several minutes per day at a frequency of at least once per month Potential participants who meet any of the following criteria will not be eligible for participation in this study.

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.
  • A documented history of developmental delay or intellectual disability or WASI <70.
  • Previous or current SCID diagnosis of bipolar disorder I.

  • Previous or current use of antipsychotic or antidepressant medication is not an exclusion criterion. In the case of current antipsychotic or antidepressant use, we will taper and cease this at entry to the study. This is consistent with clinical guidelines because antipsychotics are not indicated for the UHR population (147, 148) and antidepressants in young people are recommended only for those with severe depression, with psychosocial interventions recommended for those with mild-moderate depression (149). Most UHR cases who suffer from depression have mild-moderate rather than severe depression (143, 150). If they develop severe depression during the course of the study they are likely to meet the discontinuation criterion of risk to self and be commenced on antidepressant medication.

  • It is important to note that while these medications are not specifically indicated for use in this population, there have been a number of studies (e.g. 38, 39) that have highlighted the benefit of antidepressants. Antidepressants could reduce risk by improving mood and thereby indirectly reducing faulty appraisal of anomalous experiences linked to future psychosis. Alternatively, they may modulate response to environmental stress and adversity, which has been found to increase risk for psychosis (41).

  • In Steps 1 and 2 antidepressants will not be permitted. The use of antipsychotics or mood stabilizers is not permitted for the duration of the study except as described in the fast fail section (24 months). Young people seeking help via the EDAPT clinic are routinely screened using the SCID, and as clinically appropriate, an additional screening tool will be used by clinicians which will help them determine the UHR status of their clients. This tool is the Prodromal Questionnaire-Brief (PQ-B)(144). Those who score 6 or more positive symptoms on the PQ-B will be assessed using the SIPS, SOFAS, Global Assessment of Functioning-Modified (GAF-M) and Global Functioning: Social and Role Scales to determine UHR status. A cut-off score of 6 on the PQ-B screening tool has previously been found to identify UHR+ cases with high sensitivity (87%) and specificity (87%) (144) and has also been found to identify a more enriched sample for psychosis risk (146).

  • No pregnant women or prisoners will be included.

  • Only participants who meet all of the inclusion and none of the exclusion criteria will be eligible to participate in the study.

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $25 for the initial study visit and $25 for subsequent appointments. If you successfully complete all follow-up appointments, you will also receive a $50 bonus payment.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for two years. You will be expected to attend 10 research study visits in addition to psychotherapy sessions.
Recruitment period
From Aug. 27, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Tyler Lesh
Research Topic
Conditions:
  • Psychotic Disorders
  • Personality Disorders
  • Clinical High Risk

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