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Completed

NCT Number: NCT01479413

Mitochondria and Schizophrenia: Effects of Antipsychotic Drugs

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Psychiatry, Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • The patients had the ability to complete the written inform consent.

Exclusion criteria

  • Alcohol abuse or dependence
  • Smoking more than 1 pack per day
  • Concurrent use of mood stabilizer or beta-blocker

Treatment and study plan

Primary outcomes

  1. Serum oxidative stress

    Time frame: 15 months

    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

  2. DISC1 gene polymorphism

    Time frame: 15 months

Secondary outcomes

  1. PANSS score

    Time frame: 15 months

    Positive and Negative Syndrome Scale to reflect the severity of psychopathology

  2. Obesity

    Time frame: 15 months

    obesity defined by body mass index (BMI)>=26.4

  3. Metabolic syndrome

    Time frame: 15 months

  4. Drug response

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Nov 24, 2011
Registry last updated
Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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