Clinical trial NCT01479413: Mitochondria and Schizophrenia: Effects of Antipsychotic Drugs
Official title: Mitochondria and Schizophrenia: Effects of Antipsychotic Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Oxidative stress
Mitochondria
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Serum oxidative stress
timeFrame: 15 months
measure: DISC1 gene polymorphism
timeFrame: 15 months
Secondary outcomes:
measure: PANSS score
timeFrame: 15 months
measure: Obesity
timeFrame: 15 months
measure: Metabolic syndrome
timeFrame: 15 months
measure: Drug response
timeFrame: 15 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Psychiatry, Chang Gung Memorial Hospital
Study officials:
affiliation: Chang-Gung Memorial Hospital, Kaohsiung
name: Tiao-Lai Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: