Striatal Connectivity and Clinical Outcome in Psychosis

NCT02822092 | Completed DMC

• 1 other identifier: HS16-0411
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychotic Disorders

Outcome Measures

Primary Outcomes (1)

• efficacy of risperidone or aripiprazole for psychotic symptoms

  To examine the efficacious treatment of psychotic symptoms with either risperidone or aripiprazole measured by specific items on the Brief Psychiatric Rating Scale - conceptual disorganization, grandiosity, hallucinatory behavior, unusual thought content

  12 weeks

Secondary Outcomes (2)

• Relationship between efficacious treatment of psychotic symptoms and changes in functional connectivity of the striatum

  12 weeks

• Predicting treatment efficacy from baseline fMRI scans

  12 weeks

Study Arms (2)

Patients with Psychotic Disorders taking Risp. or Arip.

Risperidone or aripiprazole will be administered. Subjects will start risperidone 1 mg qhs or 5mg qhs aripiprazole; on day 4 the daily dose will be increased to 2 mg risperidone or 10mg aripiprazole and to 3 mg risperidone or 15mg aripiprazole at day 7. The target dose is 3 mg risperidone or 15 mg aripiprazole daily but patients who remain psychotic can be increased to 4 mg risperidone or 20mg aripiprazole at week 4; 5 mg risperidone or 25 mg aripiprazole at week 6 and 6 mg risperidone or 30 mg aripiprazole at week 8. Study Psychiatrists will be able to increase faster if symptoms don't improve as well as decrease for side effects. These dose ranges conform with standard clinical practice and are within the FDA approved dosing ranges for schizophrenia, and schizoaffective disorder. Subjects advance in the risperidone titration schedule until they respond or develop dose-limiting side effects.

Drug: Risperidone or Aripiprazole (patients only)

Healthy Volunteers

Healthy Volunteers will participate in MR imaging, Electroencephalogram , and cognitive testing.

Interventions

Risperidone or Aripiprazole (patients only) DRUG

Inpatients deemed eligible for the study, we be put on open-label risperidone

Also known as: Risperidal, Aripiprazole

Patients with Psychotic Disorders taking Risp. or Arip.

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers and Patients with Psychotic Disorders

You may qualify if:

• 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.

You may not qualify if:

• serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain
• any medical condition which requires treatment with a medication with psychotropic effects
• significant risk of suicidal or homicidal behavior
• cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
• 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
• age 15 to 40
• competent to sign informed consent
• lifetime history of any mood disorder or any psychotic disorder as determined by clinical interview using the SCID-NP
• MR imaging contraindications
• neurologic conditions
• any serious non-psychiatric disorder that could affect brain functioning
• mental retardation

Sponsors & Collaborators

• Northwell Health: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Drug Levels

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Risperidone; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Anil Malhotra, MD

  The Zucker Hillside Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 4, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

US (1)