Striatal Connectivity and Clinical Outcome in Psychosis

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwell Health
• Collaborator: National Institutes of Health (NIH)
• Treatments: Aripiprazole; Risperidone

Criteria

Patients

Inclusion Criteria:

1. 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);

2. 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;

3. 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;

4. is in a early phase of illness as defined by having taken antipsychotic medications for a cumulative lifetime period of 4 weeks or less,

5. age 15 to 40;

6. competent and willing to sign informed consent; and

7. for women, negative pregnancy test and agreement to use a medically accepted birth control method.

Exclusion Criteria:

1. serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain

2. any medical condition which requires treatment with a medication with psychotropic effects

3. significant risk of suicidal or homicidal behavior

4. cognitive or language limitations, or any other factor that would preclude subjects providing informed consent

5. medical contraindications to treatment with risperidone or aripiprazole monotherapy (e.g. neuroleptic malignant syndrome with prior risperidone exposure)

6. lack of response to a prior adequate trial of risperidone or aripiprazole

Healthy Volunteers

Inclusion

1. age 15 to 40

2. competent to sign informed consent

Exclusion

1. lifetime history of any mood disorder or any psychotic disorder as determined by clinical interview using the SCID-NP

2. MR imaging contraindications

3. neurologic conditions

4. any serious non-psychiatric disorder that could affect brain functioning

5. mental retardation