Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001921
Other study ID # 990172
Secondary ID 99-M-0172
Status Completed
Phase
First received
Last updated
Start date September 21, 1999
Est. completion date June 8, 2018

Study information

Verified date June 8, 2018
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will explore how the brain works during memory testing in an effort to understand why some patients with schizophrenia have memory difficulties.

Patients with schizophrenia and their unaffected family members are eligible for this study. Studying family members may help identify the genes related to the memory deficit in schizophrenia. Normal volunteers will also be studied.

Normal volunteers, patients with schizophrenia, and their family members interested in participating in this study will be screened with a complete medical examination and psychiatric assessment, and performance of simple tasks. Study participants will be shown numbers on a screen and asked to recall them after a brief period. This will be done during electroencephalographic (EEG) recording, in which electrodes attached to the scalp measure the brain s electrical activity. The same test will be repeated while the patient has magnetic resonance imaging of the brain. The combined MRI and EEG testing will permit better localization of the brain s electrical activity.

...


Description:

It is the aim of this study to investigate the functional activation and coupling between brain regions in normals, patients with schizophrenia and unaffected family members. We will perform electrophysiological recordings (MEG, EEG) during cognitive activation (Continuous Performance Task, Sternberg paradigm, working memory). We will focus on the investigation of oscillatory brain activity as this is considered to be crucial for information processing related to neuronal integration. The measurements will be closely adapted to equivalent fMRI-measurements presented as an independent protocol (00-M-0085). The combination of both methods will help to improve activity source localization (MEG/EEG) and correlation of this activity between different parts of the brain. In addition, local activity patterns (fMRI) can be better characterized in the time domain (tonic versus phasic BOLD-activation). We will address whether cognitive activation goes along with an increase or decrease of correlation between regional brain areas. In this context, we will investigate whether this correlated activation pattern is different in schizophrenics and unaffected siblings when compared with normals. The study is integrated with the schizophrenia-sibling study (95-M-0150). Siblings of schizophrenic patients are investigated in order to achieve a better understanding of the genetic determination of schizophrenia-related pathophysiology.


Recruitment information / eligibility

Status Completed
Enrollment 1386
Est. completion date June 8, 2018
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility - INCLUSION CRITERIA:

Controls:

1. No psychiatric or severe chronic medical illness at the time of the study, and by history. This includes the absence of substance abuse histories, learning disabilities and all DSM IV disorders. The investigators will evaluate medical histories and medical conditions that are judged not to interfere with the study may be allowed.

2. No use of psychotropic substances in the last 3 months.

3. There is no upper age limit the lower age limit is 18 years.

Patients:

1) Schizophrenia, any subtype or schizoaffective disorder according to DSM IV, as detailed in protocol # 89-M-0160 ("Inpatient evaluation of neuropsychiatric inpatients", Dr. Jose Apud, principal investigator) and # 95-M-0150 ("A Longitudinal Investigation of Siblings of Schizophrenic and Manic-Depressive Patients", Dr. Daniel R. Weinberger, principal investigator).

EXCLUSION CRITERIA:

Controls and patients:

1. Impaired hearing.

2. Pregnancy (only for purpose of MRI procedures under separate protocols)

3. Head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma. Patients or healthy volunteers with a known risk from exposure to high magnetic fields (e.g. patients with pace makers) and those who have metallic implants (e.g. braces) in the head region (likely to create artifact on the MRI scans) will be excluded from participating in the fMRI studies.

Patients:

1. Coexistence of another major mental illness at the time of the study. If the patients experienced other mental illnesses in the past (e.g. a learning disability or major depression), then this should be judged to be fully recovered.

2. Criteria for substance abuse met in the last 6 months.

3. Criteria for substance dependence met in the last year. If criteria for dependence were met in the past, then the duration of the disorder was less than 3 years, or not judged to have produced long-term brain changes to allow the patient to be in the study.

4. Major concurrent medical illness likely to interfere with the acquisition of the task.

5. Concomitant medications which could interfere with performance on the task.

6. Presence of dyskinetic movements of the face and tongue (likely to interfere with eyeblink measures), or of gross involuntary movements of the whole body (likely to interfere with positioning in the MRI scanner).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Altamura M, Carver FW, Elvevåg B, Weinberger DR, Coppola R. Dynamic cortical involvement in implicit anticipation during statistical learning. Neurosci Lett. 2014 Jan 13;558:73-7. doi: 10.1016/j.neulet.2013.09.043. Epub 2013 Sep 27. — View Citation

Rutter L, Nadar SR, Holroyd T, Carver FW, Apud J, Weinberger DR, Coppola R. Graph theoretical analysis of resting magnetoencephalographic functional connectivity networks. Front Comput Neurosci. 2013 Jul 12;7:93. doi: 10.3389/fncom.2013.00093. eCollection 2013. — View Citation

Siebenhühner F, Weiss SA, Coppola R, Weinberger DR, Bassett DS. Intra- and inter-frequency brain network structure in health and schizophrenia. PLoS One. 2013 Aug 26;8(8):e72351. doi: 10.1371/journal.pone.0072351. eCollection 2013. — View Citation

See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1