NCT02822092Completed
Striatal Connectivity and Clinical Outcome in Psychosis
Source: ClinicalTrials.gov · Last updated 21 Feb 2024
Brief summary (registry, in English)
This is an observational neuroimaging treatment study. This study involves examining the neural circuitry of controlled treatment of patients presenting with a first-episode of psychosis with risperidone or aripiprazole. Patients who present for treatment of a first psychotic episode with a schizophrenia spectrum diagnosis and who are eligible to undergo treatment with either risperidone or aripiprazole will be offered participation in the study. Clinical ratings, neuropsychological testing, neuroimaging and EEG will be conducted at baseline. Additionally, subjects will undergo the same assessments at week 12 to determine treatment-related biomarkers. Clinical ratings, including neurocognitive testing, will be conducted by blinded raters at study visits during treatment. Healthy controls (N=50) will also be recruited and scanned twice (12-week interval) to control for effects of time and practice.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 196 (actual)
- First submitted
- 27 Jun 2016
- Start date
- Jul 2016
- Primary completion date
- Dec 2023
- Lead sponsor
- Northwell Health
- Diseases
- Schizophrenia
- NCT number
- NCT02822092
What you commit to
- Study type: Observational
- Participants enrolled: 196
- From Jul 2016 to the primary completion date, Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- any medical condition which requires treatment with a medication with psychotropic effects
- medical contraindications to treatment with risperidone or aripiprazole monotherapy (e.g. neuroleptic malignant syndrome with prior risperidone exposure)
- lack of response to a prior adequate trial of risperidone or aripiprazole
- Healthy Volunteers
- Inclusion
Other illness
- serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain
- lifetime history of any mood disorder or any psychotic disorder as determined by clinical interview using the SCID-NP
- neurologic conditions
- any serious non-psychiatric disorder that could affect brain functioning
Age
- age 15 to 40
Other
- significant risk of suicidal or homicidal behavior
- cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
- competent to sign informed consent
- Exclusion
- MR imaging contraindications
- mental retardation
Who the study is looking for
- current DSM-IV-defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, brief psychotic disorder, psychotic disorder NOS, bipolar I with psychotic features (acute manic or mixed episode), major depressive disorder with psychotic features as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First et al, 1994);
- does not meet DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, shared psychotic disorder, or a mood disorder without psychotic features;
- current positive symptoms rated ≥4 (moderate) on one or more of these BPRS (Woerner et al., 1988) items: conceptual disorganization, grandiosity, hallucinatory behavior, unusual thought content;
- is in a early phase of illness as defined by having taken antipsychotic medications for a cumulative lifetime period of 4 weeks or less,
- age 15 to 40;
- competent and willing to sign informed consent; and
- for women, negative pregnancy test and agreement to use a medically accepted birth control method.
Criteria the registry did not label
- Patients
Age in the registry: 15 years to 40 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zucker Hillside Hospital Coordinator of this site? Confirm its status | Glen Oaks | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.