The Partners Genetics Collaborative Study of Schizophrenia

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ClinicalTrials.gov Identifier: NCT00319904

Recruitment Status : Completed

First Posted : April 27, 2006

Last Update Posted : October 19, 2017

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Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Daphne Holt, Massachusetts General Hospital

Study Description

Brief Summary:

We will collect DNA from 500 rigorously diagnosed patients with schizophrenia to allow us in the future to examine phenotypic subtypes in relation to genetic variants. Phenotypes will include subgroups based on clinical symptoms, medication response, or other biological markers including neuroimaging or pharmacologic challenges.

Condition or disease
Schizophrenia

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Detailed Description:

Specific Aims:

Subjects:

DNA samples and clinical characterization will be obtained from 500 schizophrenia patients treated at the Freedom Trail Clinic of the Erich Lindemann Mental Health Association and the MGH First Episode Psychosis Program.

The diagnostic interview will be conducted by a research psychiatrist and will typically take between 1-3 hours. The following clinical data will be obtained for all subjects:

Demographics (age, gender, ethnicity) Weight, height Current medications and doses Age of onset (prodrome and psychosis) Incidence of psychotic disorders in first-degree family members (without identifiers) Diagnosis with subtype History of hallucinations, delusions, negative symptoms, disorganization and mood disorder History of response (full, partial, or no response) of symptoms (hallucinations, delusions, disorganization and negative symptoms) to conventional antipsychotics, atypicals or clozapine Number of hospitalizations Smoking behaviors (using the Fagerstrom)

The additional clinical assessment will take approximately 2-3 hours and will include the following clinical rating scales and cognitive tests:

Symptom Rating Scales:

Positive and Negative Symptom Scale (PANSS) Scale for Assessment of Negative Symptoms (SANS) Abnormal Involuntary Movements Scale (AIMS) (examination) Clinical Global Impressions-Severity of Illness Scale (CGI) (observational) Beck Depression Inventory (BDI-II) Simpson-Angus Scale (SAS)

Cognitive Battery:

Wechsler Adult Intelligence Scale (selected subtests) (WAIS-III) North American Adult Reading Test (NAART) Stroop Test Wisconsin Card Sorting Test (WCST) California Verbal Learning Test (CVLT) Verbal Fluency (FAS) Finger Tapping CPT-IP

Collection of Blood Samples:

Four tubes of blood will be drawn from an antecubital vein from each participant using an EDTA and non-EDTA vacutainers. Tubes will be labeled with the study, date, and an encrypted identification of the subject. Samples will be used for DNA extraction and measurement of serum and RBC folate and homocysteine.

Genetic Analysis:

Genes will be studied that have been identified in linkage studies of patients with schizophrenia that have compelling biology relevant to potential mechanisms of etiology or drug response. Approximately 20 candidate genes have been identified with varying levels of evidence-this number is rapidly expanding. We will review the potential list of candidate genes when we have completed collecting the sample and will identify the most promising genotypic targets for analysis. If approved by the IRB, comparisons with other populations (such as depressed patients or nonpsychiatric controls) may be performed in collaboration with other investigators.

Risks:

While the clinical assessment may be stressful, the questions contained in the diagnostic instruments do not differ from those asked in routine clinical evaluations. Phlebotomy may produce discomfort, bruising, and rarely, infection. In theory, release of genetic information to patients could be upsetting and release to other parties could represent a serious breach of privacy. Extensive precautions will be taken to prevent such an occurrence.

All DNA analyses will be performed on anonymous samples.

Subject Remuneration:

Subjects who agree to phlebotomy and complete the psychiatric evaluation will be remunerated $25 for their time. Subjects who complete the additional cognitive battery and clinical rating scales will be remunerated a total of $50 for their time.

Study Design

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Study Type :	Observational
Actual Enrollment :	451 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	The Partners Genetics Collaborative Study of Schizophrenia
Study Start Date :	March 2001
Actual Primary Completion Date :	October 2017
Actual Study Completion Date :	October 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Schizophrenia

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

phenotypic subtypes in relation to genetic variants [ Time Frame: Baseline ]
We will collect DNA from 500 patients with schizophrenia to examine phenotypic subtypes in relation to genetic variants. Phenotypes will include subgroups based on clinical symptoms, medication response, or other biological markers including neuroimaging or pharmacologic challenges.

Biospecimen Retention: Samples With DNA

DNA is extracted and stored for future anaysis of genes that may be associated with schizophrenia

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adults with Schizophrenia

Criteria

Inclusion Criteria:

Schizophrenia, any subtype Ages 18-70 years Males or females English speaking Ability to complete symptom rating scales and cognitive tests Ability to provide informed consent

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319904

Locations

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United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Institute of Mental Health (NIMH)

Investigators

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Principal Investigator:	Daphne J Holt, M.D., PhD	Massachusetts General Hospital

More Information

Publications of Results:

Roffman JL, Gollub RL, Calhoun VD, Wassink TH, Weiss AP, Ho BC, White T, Clark VP, Fries J, Andreasen NC, Goff DC, Manoach DS. MTHFR 677C --> T genotype disrupts prefrontal function in schizophrenia through an interaction with COMT 158Val --> Met. Proc Natl Acad Sci U S A. 2008 Nov 11;105(45):17573-8. doi: 10.1073/pnas.0803727105. Epub 2008 Nov 6.

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Responsible Party:	Daphne Holt, Associate Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00319904
Other Study ID Numbers:	2001-P-000560
First Posted:	April 27, 2006 Key Record Dates
Last Update Posted:	October 19, 2017
Last Verified:	October 2017

Keywords provided by Daphne Holt, Massachusetts General Hospital:


Schizophrenia DNA

Additional relevant MeSH terms:

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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders

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