Antipsychotic Effects on Brain Function in Schizophrenia

NCT01913327 | Terminated Phase 4 Results

• 1 other identifier: 2010489
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine whether two commonly-prescribed antipsychotic medications (aripiprazole and risperidone) have different effects on brain function and cognition in schizophrenia patients.

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Keywords

cognition; executive function; prefrontal cortex; locus coeruleus

Outcome Measures

Primary Outcomes (1)

• Brain Activation by fMRI

  The magnitude of BOLD signal change associated with cognitive task performance will be directly compared between the aripiprazole and risperidone-treated groups, as well as the degree of functional connectivity between the locus coeruleus and the prefrontal cortex, also during during cognitive task performance.

  8 weeks

Secondary Outcomes (2)

• Cognitive Performance

  8 weeks

• Brain Activation in Response to Single-dose Modafinil

  one day

Other Outcomes (1)

• Psychiatric Symptoms

  8 weeks

Study Arms (2)

aripiprazole

EXPERIMENTAL

aripiprazole with flexible, blind dosing between 7.5 mg and 30 mg, once daily.

Drug: Aripiprazole; Drug: Modafinil

risperidone

ACTIVE COMPARATOR

risperidone with flexible, blind dosing between 1 mg and 8 mg, once daily.

Drug: Risperidone; Drug: Modafinil

Interventions

Aripiprazole DRUG

Also known as: Abilify

aripiprazole

Risperidone DRUG

Week One, Risperidone 1 mg po qd; Week Two, 2 mg po qd; Week Three, 4 mg po qd; Week Four, 6 mg po qd; Week Five (and thereafter), 8 mg po qd.

Also known as: Risperdal

risperidone

Modafinil DRUG

Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication.

Also known as: Provigil

aripiprazole; risperidone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• less than 40 years old;
• currently meet criteria for schizophrenia, schizophreniform disorder or schizoaffective disorder from the DSM-IV-TR;
• require new or changed treatment with antipsychotic medication.

You may not qualify if:

• older than 40 years;
• in current antipsychotic treatment that is satisfactory;
• treatment-refractory psychosis;
• active substance-related disorder;
• clinically-unstable (e.g. acute symptoms requiring emergent or acute-care, including acute suicide risk);
• neurological illness or poorly-controlled medical illness;
• currently taking medications for serious medical illness which have significant interactions with modafinil;
• active pregnancy;
• intelligence less than 70 (on standard test);
• contraindications for fMRI (e.g. claustrophobia, metal foreign bodies, etc.);
• uncorrectable visual acuity impairment.

Sponsors & Collaborators

• University of California, San Francisco: lead
• The Dana Foundation: collaborator

Study Sites (1)

University of California

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Aripiprazole; Risperidone; Modafinil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidinones; Pyrimidines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Early termination leading to small, inadequate numbers of subjects analyzed.

Results Point of Contact

• Title: Michael Minzenberg
• Organization: University of California San Francisco

MMinzenberg@mednet.ucla.edu

5104122199

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 1, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 20, 2020
• Results First Posted: April 20, 2020

Record last verified: 2020-04

Locations

US (1)