Mitochondria and Schizophrenia: Effects of Antipsychotic Drugs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tiao-Lai Huang, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01479413
First received: July 10, 2011
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

The investigators will investigate

  1. the relationships between oxidative stress-, apoptosis-related markers, mitochondria DNA copy numbers and the clinical psychopathology of schizophrenia, including severity of positive and negative symptoms, obesity and metabolic syndrome.
  2. the relationships between aberrant mitochondria genes (single nucleotide polymorphism of D-loop region-related genes and haplogroup N9a), DISC1 gene polymorphism, and clinical phenotypes in Taiwanese populations.
  3. whether these biological markers could be as clinical markers in schizophrenia for a long-term follow-up study.

Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mitochondria and Schizophrenia: Effects of Antipsychotic Drugs

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Serum oxidative stress [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    serum malondialdehyde (MDA) content, serum free thiols, serum glutathione, catalase, Superoxide dismutase, glutathione peroxidase, proapoptotic markers (bad and bax) and antiapoptotic markers (bcl-2 and bcl-x1), quantification of mitochondrial DNA

  • DISC1 gene polymorphism [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PANSS score [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    Positive and Negative Syndrome Scale to reflect the severity of psychopathology

  • Obesity [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    obesity defined by body mass index (BMI)>=26.4

  • Metabolic syndrome [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Drug response [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 77
Study Start Date: August 2009
Study Completion Date: September 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Schizophrenia

Detailed Description:

In past study, we had shown that there were significant differences in serum Lpo (lipid peroxidation) and Thiol levels between patients with schizophrenia and healthy controls. For patients taking risperidone, there were significant decreases in serum Thiol levels. In addition, there were also significant differences in age of onset of PPAR gamma coactivator 1α (PGC-1α) polymorphism for schizophrenia patients. Therefore, we want to know the relationships between oxidative stress-, apoptosis-related markers, mitochondria DNA copy numbers and the clinical psychopathology of schizophrenia, including severity of positive and negative symptoms, obesity and metabolic syndrome.

In past study, we also found that there were significant differences in 10 SNPs located in the D-loop region-related genes between patients and healthy controls. Three SNPs could be found in Mitomap data, but another seven SNPs not been found in the Mitomap and they could be more confirmed. In addition, Tanaka et al. found that haplogroup N9a was related to diabetes and metabolic syndrome in Asia. Therefore, we were interested to clarify the relationships between above related mitochondria genes and clinical phenotypes in Taiwanese populations,.

In addition, we also want to see whether these biological markers could be as clinical markers in schizophrenia for a long-term follow-up study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study will be conducted in our clinical setting. By a semi-structured interview for DSM-IV criteria, about 300 schizophrenic patients will be recruited in this study.

Criteria

Inclusion Criteria:

  1. Schizophrenic patients will be recruited in psychiatric inpatients and outpatients departments according to DSM-IV criteria by a semi-structured interview. The assessment will be done by two senior psychiatrists. The intra- rater and inter-rater reliability will be done before this project started.
  2. The patients had the ability to complete the written inform consent.

Exclusion Criteria:

  1. Alcohol abuse or dependence
  2. Smoking more than 1 pack per day
  3. Concurrent use of mood stabilizer or beta-blocker
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479413

Locations
Taiwan
Department of Psychiatry, Chang Gung Memorial Hospital
Kaohsiung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Tiao-Lai Huang, M.D. Chang-Gung Memorial Hospital, Kaohsiung
  More Information

No publications provided

Responsible Party: Tiao-Lai Huang, Head of Department of Psychiatry, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01479413     History of Changes
Other Study ID Numbers: CMRPG891561
Study First Received: July 10, 2011
Last Updated: September 10, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
Schizophrenia
Oxidative stress
Mitochondria

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 29, 2014