Trajectories of Treatment Response as Window Into the Heterogeneity of Psychosis: a Longitudinal Multimodal Imaging Study

NCT03442101 | Active Not Recruiting FDA Drug

• 2 other identifiers: IRB-300000959R01MH113800
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Psychosis is a heterogeneous disorder and present treatment only works for a limited number of patients. In order to identify new therapeutic targets, this study will longitudinally characterize the underlying pathologies in those with poor treatment response using complimentary brain imaging modalities.

Conditions

Psychosis

Outcome Measures

Primary Outcomes (3)

• Measures of brain structure

  Measures of brain structure, as measured with diffusion tensor imaging (DTI) that are associated at baseline (when patients are unmedicated) with subsequent treatment response to antipsychotic medication.

  32 weeks

• Measures of brain function

  Measures of brain function, as measured with functional MRI (fMRI) that are associated at baseline (when patients are unmedicated) with subsequent treatment response to antipsychotic medication.

  32 weeks

• Measures of brain biochemistry

  Measures of brain biochemistry, as measured with MR Spectroscopy, that are associated at baseline (when patients are unmedicated) with subsequent treatment response to antipsychotic medication.

  32 weeks

Secondary Outcomes (3)

• Changes in measures of brain structure

  32 weeks

• Changes in measures of brain function

  32 weeks

• Changes in measures of brain biochemistry

  32 weeks

Other Outcomes (3)

• Trajectory of treatment response

  32 weeks

• Trajectory of treatment response

  32 weeks

• Trajectory of treatment response

  32 weeks

Study Arms (1)

Treatment group

These participants are newly diagnosed with psychosis.

Drug: Patients with psychosis will be treated with known antipsychotic medication

Interventions

Patients with psychosis will be treated with known antipsychotic medication DRUG

Subjects with first episode psychosis will be treated with risperidone, the most frequently used antipsychotic drug (APD) for 32 weeks. The study will follow a rigorous longitudinal design to capture treatment response whereby those without an adequate response after 16 weeks of treatment will be switched to aripiprazole, another APD for 16 weeks. All patients will be scanned four times: at baseline and after 6, 16, and 32 weeks of treatment.

Also known as: Brain imaging scans will be obtained 4 times during the study

Treatment group

Eligibility Criteria

• Age: 17 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

First episode psychosis subjects

You may qualify if:

• A diagnosis of first episode psychosis
• Never been treated with an antipsychotic medication
• Between the age of 17 and 35

You may not qualify if:

• Inability to sign informed consent assessed by the Evaluation to sign - - Consent form
• Poorly controlled acute or chronic medical and neurological conditions
• History of head trauma with loss of consciousness for \>2 minutes
• Clinically significant depression, hypomania, or mania
• Active substance abuse or dependence (except for nicotine)
• Suspected substance-induced psychosis
• Treatment with drugs known to affect brain glutamate levels
• Pregnant females

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Sparks Center

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

• Maximo JO, Briend F, Armstrong WP, Kraguljac NV, Lahti AC. Salience network glutamate and brain connectivity in medication-naive first episode patients - A multimodal magnetic resonance spectroscopy and resting state functional connectivity MRI study. Neuroimage Clin. 2021;32:102845. doi: 10.1016/j.nicl.2021.102845. Epub 2021 Sep 29.

  PMID: 34662778 DERIVED

• Maximo JO, Nelson EA, Armstrong WP, Kraguljac NV, Lahti AC. Duration of Untreated Psychosis Correlates With Brain Connectivity and Morphology in Medication-Naive Patients With First-Episode Psychosis. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Feb;5(2):231-238. doi: 10.1016/j.bpsc.2019.10.014. Epub 2019 Nov 9.

  PMID: 31902581 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Antipsychotic drug plasma levels

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Adrienne Lahti, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 22, 2018
• Study Start: April 1, 2018
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

US (1)