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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017269
Receipt No. R000020040
Scientific Title Difference in prefrontal activity between Sertraline responders versus non-responders in patients with major depression: A near infrared spectroscopy study
Date of disclosure of the study information 2015/04/24
Last modified on 2015/04/24

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Basic information
Public title Difference in prefrontal activity between Sertraline responders versus non-responders in patients with major depression: A near infrared spectroscopy study
Acronym Difference in prefrontal activity between Sertraline responders versus non-responders in patients with major depression.
Scientific Title Difference in prefrontal activity between Sertraline responders versus non-responders in patients with major depression: A near infrared spectroscopy study
Scientific Title:Acronym Difference in prefrontal activity between Sertraline responders versus non-responders in patients with major depression.
Region
Japan

Condition
Condition Depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1)The primary objective of this study is to investigate specific pre-treatment hemodynamic pattern which may predict response to the 12-week sertraline treatment in patients with acute non-psychotic major depressive disorder. Other demographic and clinical factors will also be compared between treatment responders and non-responders.
2)We will also compare prefrontal activation during executive-control task and emotional judgment task between responders and non-responders after a 12-week sertraline treatment.
3)Finally, the changes in hypofrontality measured by NIRS during executive-control task and emotional judgment task and depression severity during the sertraline treatment period will be investigated as well.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Baseline concentrations of oxygenated hemogloblin [oxy-Hb] during VFT (letter-based word retrieval) and EJT measured by NIRS will be compared between treatment responders and non-responders. Responders will be defined as those who score 50% or greater reduction on baseline GRID-HAMD17 score at the week 12.
Key secondary outcomes 1.Changes between baseline and the 12 week concentrations of oxy-Hb during VFT and EJT measured by NIRS will be compared between treatment responders and non-responders.
2.Severity of objective depression as measured by GRID HAMD17 and severity of subjective depression as measured by BDI-2.
3.Remission rate at week 12 (Remission will be defined as 7 or less on GRID-HAMD17)
4.Level of quality of life as measured by the European Quality of Life Questionnaire Dimensions (EQ-5D).
5.Level of global burden of side-effect as measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) Scale.
6.Safety and tolerability will be measured by serious adverse event reports (SAEs) and premature discontinuation rate at week 12.
7.The 16-item Quick Inventory of Depressive Symptomatology Self-Reported (QIDS-SR16) will be measured during the protocol treatment for monitoring safety and the acquisition of treatment.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 The protocol strongly encourages all patients to receive sertraline 100 mg/d for 12 weeks using a flexible dose schedule to maximize the chances of obtaining a remission, except for those with clear intolerance. Initial strategy will be to titrate sertraline up to the minimum dose of the effective range (50 mg/d). If <20% reduction in baseline symptom severity as measured by the QIDS-SR16 is found at week 4, the minimum of the effective range (50mg/d) will be titrated (assuming tolerable side effects) to the maximum dose of the effective range (100 mg/d). However, appropriate flexibility will be allowed in dose escalation schedule (i.e. a slower or faster escalation schedule), so that patients with concomitant general medical disorders, with other psychiatric disorders or those who are sensitive to side effects can be managed well and included safely in the sample, in order to optimize the chances of therapeutic benefit for each patient.
The recommended treatment visits will be at 0, 2, 4, 6, 8, 10 and 12 weeks. Exit from study, according to the protocol is week 12 (time-point (t3)). Optional visits are allowed between bi-weekly visits if needed. Sessions will typically last about 15 to 30 minutes, and focus on burden of symptoms and side effects in supportive manner. Non-specific psychotherapies, exercise, psychoeducation and brief problem-solving are allowed. Intolerance is declared if a participant discontinues sertraline during the initial 4 weeks for any reason or intolerable side effects that require the medication to stop sertraline at a point subsequent to the 4th week of treatment (independent of the symptomatic status).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1.Fulfill criteria for major depressive disorder, as defined by DSM-IV criteria without psychotic features, as determined by clinical assessment and confirmed by the SCID at screening (t1).
2.Aged 20-65 years at t1.
3.Have a GRID-HAMD17 total score 16 at t1 and baseline (t2).
4.The major depressive disorder is the primary diagnosis for the treatment and treating physician has judged sertraline to be appropriate for prescribing.
5.Have an education level and a degree of understanding such that the patient can communicate with the study personnel.
6.Patients must be competent and able to give their own informed consent.
Key exclusion criteria 1.Have had any additional ongoing DSM-IV Axis I condition other than major depressive disorder that is considered as the primary diagnosis within 1 year of t1.
2.Have a current or lifetime diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder at t1.
3.Have a history of substance abuse/dependence within 1 year of t1, not including caffeine and nicotine.
4.Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with the study protocol.
5.Have an evidence of being resistant to sertraline 100 mg/d (maximum dose of the effective range) for at least 6 weeks during this current depressive episode.
6.Women who are currently pregnant or breastfeeding.
7.Patients who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others.
8.Have a serious or unstable medical illness, including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, renal disease, or clinically significant laboratory or ECG abnormality.
9.Have a history of traumatic head injury or organic brain syndrome such as stroke.
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Mimura
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi,Shinjuku-ku,Tokyo JAPAN
TEL 03-5363-3829
Email mimura@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukiko MIYASAKA
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi,Shinjuku-ku,Tokyo JAPAN
TEL 03-5363-3829
Homepage URL
Email miyasaka@a5.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Pfizer
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2012 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 24 Day
Last modified on
2015 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020040

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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