Mitochondria and Schizophrenia: Effects of Antipsychotic Drugs

Completed

• Conditions: Schizophrenia

• Registration Number: NCT01479413
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2011-07-10
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-24
• Primary Completion: 2012-07
• Status Verified: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-10
• Last Update Posted: 2013-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DISC1 gene polymorphism	15 months
Serum oxidative stress	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

Secondary Outcome Measures

Name	Time	Method
PANSS score	15 months	Positive and Negative Syndrome Scale to reflect the severity of psychopathology
Metabolic syndrome	15 months
Drug response	15 months
Obesity	15 months	obesity defined by body mass index (BMI)\>=26.4

Trial Locations

Locations (1)

Department of Psychiatry, Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan