NCT01035996

Brief Summary

Background: \- Schizophrenia is associated with cognitive impairment in different parts of the brain, including those associated with learning and memory. The brain activity associated with these impairments, however, is poorly understood. Researchers are interested in studying how the brain chemical dopamine, which is involved in responding to incentives and rewards like money or food, works differently in the brains of people who have schizophrenia. Objectives: \- To study reward processing in individuals with schizophrenia who are taking different types of medication, compared with healthy volunteers. Eligibility: \- Individuals between 18 and 55 years of age who (a) have been diagnosed with schizophrenia/schizoaffective disorder and are taking the antipsychotic medication clozapine, (b), have been diagnosed with schizophrenia/schizoaffective disorder and are taking a different second-generation antipsychotic, or (c) are healthy volunteers. Design:

  • This study will involve one screening visit and one or more visits for testing and functional magnetic resonance imaging (fMRI) scans. During the screening visit, participants will complete questionnaires and provide information about their physical and psychological health.
  • Participants will receive training in the tasks to be performed at the scanning sessions during the screening visit.
  • During the fMRI scans, participants will complete one or two of four possible reward-based tasks:
  • A task that enables participants to win money based on their response to a target item.
  • A task that provides small amounts of juice over specific time intervals, followed by a procedure to be completed outside the scanner.
  • A task that involves choosing figures or shapes and winning money based on responses.
  • A game of chance involving predictions based on shapes shown on a screen.
  • Participants will also provide blood samples for research and testing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2005

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2005

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2017

Completed
Last Updated

December 9, 2019

Status Verified

February 13, 2017

First QC Date

December 18, 2009

Last Update Submit

December 6, 2019

Conditions

Keywords

Classical ConditioningfMRISchizophreniaTD ModelIncentive Salience

Outcome Measures

Primary Outcomes (1)

  • Whether MRI responses in components of reward circuits are attenuated in patients, in the context of paradigms that require individuals to detect mismatches between expected & experienced outcomes, and to modify responses based on those...

    one MRI

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals will be eligible for participation in one of the proposed experimental groups on the condition that they are:
  • Aged between 18 55 years.
  • In good health, based on history and physical examination
  • Right-handed (i.e. as assessed using the Edinburgh Handedness Inventory)
  • In addition, patient participants:
  • Must meet DSM-IV criteria for schizophrenia or schizoaffective disorder at the time of assessment, and
  • Must have had 4 weeks of stable pharmacological treatment (same medications at same doses).
  • Behavioral Subject Only:
  • Aged between 18 55 years.
  • In good health, based on history and physical examination
  • Right-handed (i.e. as assessed using the Edinburgh Handedness Inventory)
  • In addition, patient participants:
  • Must meet DSM-IV criteria for schizophrenia or schizoaffective disorder at the time of assessment, and
  • Must have had 4 weeks of stable pharmacological treatment (same medications at same doses).
  • Individuals will be eligible for participation in one of the proposed experimental groups on the condition that they are:
  • +14 more criteria

You may not qualify if:

  • Have any current, or previous, diagnosis of any major psychiatric disorder, i.e. to include (but not limited to) mood, anxiety, and psychiatric disorders, or any substance-induced psychiatric disorders.
  • Have any first-degree relatives with history of psychosis likely related to schizophrenia, bipolar affective disorder, or schizoaffective disorder.
  • Have previously been diagnosed with a DSM-IV Axis II spectrum disorder.
  • Patient Participants
  • Patient patients will be excluded if they meet any of the criteria already outlined, and also if they:
  • Have experienced any changes in pharmacological treatment and dose in the 4 weeks preceding study enrollment.
  • We will exclude patients whose paranoid ideation might prevent them from feeling comfortable in the task- or scanning-environment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Maryland, Baltimore

Baltimore, Maryland, 21201-1595, United States

Location

National Institute on Drug Abuse, Biomedical Research Center (BRC)

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

  • Addington D, Addington J, Schissel B. A depression rating scale for schizophrenics. Schizophr Res. 1990 Jul-Aug;3(4):247-51. doi: 10.1016/0920-9964(90)90005-r.

    PMID: 2278986BACKGROUND
  • Akil M, Kolachana BS, Rothmond DA, Hyde TM, Weinberger DR, Kleinman JE. Catechol-O-methyltransferase genotype and dopamine regulation in the human brain. J Neurosci. 2003 Mar 15;23(6):2008-13. doi: 10.1523/JNEUROSCI.23-06-02008.2003.

    PMID: 12657658BACKGROUND
  • Alain C, McNeely HE, He Y, Christensen BK, West R. Neurophysiological evidence of error-monitoring deficits in patients with schizophrenia. Cereb Cortex. 2002 Aug;12(8):840-6. doi: 10.1093/cercor/12.8.840.

    PMID: 12122032BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Elliot Stein, Ph.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2009

First Posted

December 21, 2009

Study Start

March 8, 2005

Study Completion

February 13, 2017

Last Updated

December 9, 2019

Record last verified: 2017-02-13

Locations