Mitochondria and Schizophrenia: Effects of Antipsychotic Drugs

Schizophrenia Clinical Trial

Official title:

Mitochondria and Schizophrenia: Effects of Antipsychotic Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479413
• Other study ID #: CMRPG891561
• Status: Completed
• Phase: N/A
• First received: July 10, 2011
• Last updated: September 10, 2013
• Start date: August 2009
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: September 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum oxidative stress	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	15 months	Yes
Primary	DISC1 gene polymorphism		15 months	Yes
Secondary	PANSS score	Positive and Negative Syndrome Scale to reflect the severity of psychopathology	15 months	Yes
Secondary	Obesity	obesity defined by body mass index (BMI)>=26.4	15 months	No
Secondary	Metabolic syndrome		15 months	No
Secondary	Drug response		15 months	Yes