- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01479413
Mitochondria and Schizophrenia: Effects of Antipsychotic Drugs
The investigators will investigate
- 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.
- 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.
- whether these biological markers could be as clinical markers in schizophrenia for a long-term follow-up study.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Kaohsiung, Taiwan
- Department of Psychiatry, Chang Gung Memorial Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Schizofreni
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Serum oxidative stress
Tidsramme: 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
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15 months
|
DISC1 gene polymorphism
Tidsramme: 15 months
|
15 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
PANSS score
Tidsramme: 15 months
|
Positive and Negative Syndrome Scale to reflect the severity of psychopathology
|
15 months
|
Obesity
Tidsramme: 15 months
|
obesity defined by body mass index (BMI)>=26.4
|
15 months
|
Metabolic syndrome
Tidsramme: 15 months
|
15 months
|
|
Drug response
Tidsramme: 15 months
|
15 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Tiao-Lai Huang, M.D., Chang-Gung Memorial Hospital, Kaohsiung
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMRPG891561
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