UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017269
Receipt number 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 18:40:54

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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 or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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