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Trial registered on ANZCTR


Registration number
ACTRN12611000040965
Ethics application status
Approved
Date submitted
6/01/2011
Date registered
12/01/2011
Date last updated
12/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Association of signal transduction pathway genes and their interaction with environment factors with antidepressant treatment response
Scientific title
There is an association of signal transduction pathway genes and their interaction with environment factors with antidepressant treatment response in patients of major depressive disorder.
Secondary ID [1] 253357 0
Nil
Universal Trial Number (UTN)
U1111-1118-8486
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gene and environment factors interaction 258891 0
major depressive disorder 258892 0
Condition category
Condition code
Mental Health 259031 259031 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We interviewed patients bi-weekly using a standardized protocol across centres, recording duration, dosage, compliance, outcome and side-effects. Severity of depressive symptoms at baseline and the time of the interview were assessed using the HAMD-17 by a trained senior psychiatrist, blind to patients’ genotype thereafter for 8 weeks. Dose increases of the same antidepressant drugs were allowed if the patient had not achieved Clinical Global Impression (CGI) change scores indicating “much improved” or “very much improved.” Concomitant psychotropic medications were not permitted, except for a low dose of a benzodiazepine anxiolytic for the alleviation of insomnia. Drug side effects were assessed with the Treatment Emergent Symptom Scale (TESS,) every two weeks and drug compliance was also monitored routinely by nursing interview. ‘Remission’ was defined as an equal to or less than 7 scores in the HAMD-17 total score after 8 weeks’ treatment . Patients requiring a change in antidepressant drug or demonstrating non-adherence were excluded from the study.
Intervention code [1] 257799 0
Not applicable
Comparator / control treatment
'not applicable'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259881 0
We used the UNPHASED 3.3.13 to analyses single SNP and haplotype associations. we found that CaMK pathway genes were significant associated with remission depression patients.
Timepoint [1] 259881 0
after 8 weeks treatment with SSRIs or SNRIs antidperessants.
Secondary outcome [1] 268761 0
Gene-environment interactions were analyzed by binary logistic regression with SPSS 11.0 software. There were no significant differences in CTQ scores and LES scores between remitters and non-remitters.
Timepoint [1] 268761 0
after 8 weeks treatment with SSRIs or SNRIs antidperessants.

Eligibility
Key inclusion criteria
All recruited patients were between 18-60 years old and met criteria for a diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) . All subjects were new or recently relapsed patients, drug-free for over two weeks and had a baseline score of 18 or over on the 17-item Hamilton Depression Rating Scale (HAMD-17) , having presented depressive symptoms for at least 2 weeks before entry.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included documented history of diagnoses on Axis 1 (including substance abuse, schizophrenia, schizoaffective, bipolar disorder, generalized anxiety disorders, panic disorders or obsessive compulsive disorders) of the DSM-IV, personality disorders, mental retardation, pregnancy, lactation, primary organic disease and other medical illnesses impairing psychiatric evaluation, or a history of electroconvulsive therapy within the previous 8 months. Newly-diagnosed patients were also excluded if they had manic episode in the 12 months following entry.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3120 0
China
State/province [1] 3120 0
Jiangsu

Funding & Sponsors
Funding source category [1] 258274 0
Government body
Name [1] 258274 0
National Basic Research Program of China
Address [1] 258274 0
Department of Neuropsychiatry, Affiliated Zhongda Hospital and Neuropsychiatric Research Institute of Southeast University, Nanjing, China, 210009
Country [1] 258274 0
China
Primary sponsor type
Individual
Name
Zhijun Zhang
Address
Department of Neuropsychiatry, Affiliated Zhongda Hospital and Neuropsychiatric Research Institute of Southeast University, Nanjing, China, 210009
Country
China
Secondary sponsor category [1] 257473 0
Individual
Name [1] 257473 0
Yonggui Yuan
Address [1] 257473 0
Department of Neuropsychiatry, Affiliated Zhongda Hospital and Neuropsychiatric Research Institute of Southeast University, Nanjing, China, 210009
Country [1] 257473 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260251 0
Affiliated Zhongda Hospital of Southeast University ethical committee
Ethics committee address [1] 260251 0
Department of ethical committee, Affiliated Zhongda Hospital of Southeast University, Nanjing, China, 210009
Ethics committee country [1] 260251 0
China
Date submitted for ethics approval [1] 260251 0
01/01/2007
Approval date [1] 260251 0
01/02/2007
Ethics approval number [1] 260251 0

Summary
Brief summary
The aim of this study was to examine the association of polymorphisms in candidate genes of these three signal transduction pathways with response to antidepressant treatment, and to determine the effects of, and interactions with, environment factors
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32056 0
Address 32056 0
Country 32056 0
Phone 32056 0
Fax 32056 0
Email 32056 0
Contact person for public queries
Name 15303 0
Yonggui Yuan
Address 15303 0
Department of Neuropsychiatry, Affiliated Zhongda Hospital and Neuropsychiatric Research Institute of Southeast University, Nanjing, China, 210009
Country 15303 0
China
Phone 15303 0
+86-25-8327-2023
Fax 15303 0
Email 15303 0
yygylh2000@sina.com.cn
Contact person for scientific queries
Name 6231 0
Yanyan Shi
Address 6231 0
Department of Neuropsychiatry, Nanjing First Hospital Affiliated to Nanjing Medical University, Nanjing, China, 210006
Country 6231 0
China
Phone 6231 0
+86-25-8327-2023
Fax 6231 0
Email 6231 0
syy_jill@126.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary