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New treatment option for Schizophenia Disorder
Official title Biomarkers to Enhance Early Schizophrenia Treatment
ClinicalTrials.gov ID: NCT06969755
What this study is testing
What is aripiprazole?
aripiprazole is an investigational medicine, being studied as a potential treatment for schizophenia disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is recruiting participants who are experiencing a first episode of psychosis and who have certain genetic factors that may make them respond better to certain medications that are used to treat people with psychosis.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35
You may be able to join if
- Aged 18 to 35.
- DSM5 diagnosis (as determined by the SCID5) of schizophrenia, schizoaffective disorder, schizophreniform disorder.
- Current positive symptoms rated ≥4 (moderate) on one or more of the following BPRS positive subscale items: unusual thought content, conceptual...
- Preserved striatal connectivity, as determined by screening MRI scan
- Absence of the MC4R high-risk genotype, as determined by genetic testing
You likely can't join if
- The patient reports or medical records state a serious neurological or endocrine disorder at screening that the investigator determines could...
- An abnormal EKG at screening that the investigator determines could interfere with the interpretation of the how well it works or safety measurements
- Any medical condition which requires treatment with a medication with psychotropic effects.
- Significant risk of suicidal or homicidal behavior (i.e. 'severe' risk on the Columbia Suicide Scale, a 'hostility' score of 7 on the BPRS, or an...
- Cognitive limitations, or any other factor that would preclude potential participants providing informed consent
- Contraindications to MRI (e.g. pacemaker).
See the full eligibility criteria
- Aged 18 to 35.
- DSM5 diagnosis (as determined by the SCID5) of schizophrenia, schizoaffective disorder, schizophreniform disorder.
- Current positive symptoms rated ≥4 (moderate) on one or more of the following BPRS positive subscale items: unusual thought content, conceptual disorganization, hallucinatory behavior, suspiciousness.
- Preserved striatal connectivity, as determined by screening MRI scan
- Absence of the MC4R high-risk genotype, as determined by genetic testing
- Absence of the HLA-DQB1 high-risk genotype, as determined by genetic testing
- In an early phase of illness as defined by having taken antipsychotic drugs for a cumulative lifetime period of 4 weeks or less (with exceptions of very low doses for other off-label indications, e.g. sleep)
- Ability to provide informed consent
- The patient reports or medical records state a serious neurological or endocrine disorder at screening that the investigator determines could interfere with the interpretation of the how well it works or safety...
- An abnormal EKG at screening that the investigator determines could interfere with the interpretation of the how well it works or safety measurements
- Any medical condition which requires treatment with a medication with psychotropic effects.
- Significant risk of suicidal or homicidal behavior (i.e. 'severe' risk on the Columbia Suicide Scale, a 'hostility' score of 7 on the BPRS, or an answer of 'yes' on questions 4,5 or 6 on the CDSS).
- Cognitive limitations, or any other factor that would preclude potential participants providing informed consent
- Contraindications to MRI (e.g. pacemaker).
- Meeting SCID-5 substance use disorder moderate or severe for any substance, other than nicotine within 3 months of screening visit. Meeting SCID5 substance use disorder mild for any substance other than cannabis...
- Suspected DSM5 intellectual disability based upon clinical interview and psychosocial history, as well as screening with the Weschler Test for Adult Reading (IQ score \<71)
- Prior psychosurgery
- Pregnancy (self-report)
- Seizure disorder (self-report) \-
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- La Jolla, California, United States
- Belmont, Massachusetts, United States
- Glen Oaks, New York, United States
- Toronto, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; La Jolla, California, United States; Belmont, Massachusetts, United States; Glen Oaks, New York, United States; Toronto, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.