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 * About Ventura Study
 * Who Can Take
   Part?
 * FAQs

English (USA)
 * English (USA)


MAJOR DEPRESSIVE DISORDER IS AN INVISIBLE PAIN – BUT ITS EFFECTS CAN LEAVE YOU
EXHAUSTED.


IF YOUR MEDICINE IS NOT WORKING, THERE MIGHT BE ANOTHER OPTION. CONSIDER OUR
RESEARCH STUDY FOR MDD.

People who take part may receive*:

 * Study-required care from local doctors at no cost
 * Study medication at no cost

There is no obligation, so see if you may qualify now.

See If You Pre-Qualify



ABOUT THE VENTURA STUDY


WHAT IS THE VENTURA STUDY?

The Ventura Study is a clinical research study (also called a clinical trial)
for people with major depressive disorder (MDD). MDD is a common mental disorder
with about 1 in 20 adults worldwide living with the condition. Even when
diagnosed, it can be very challenging for people to find medication that works
for them. It is reported that close to 1 in 3 patients do not respond well to
multiple medications for depression. Symptoms such as anhedonia (loss of
pleasure or interest) insomnia, restlessness, and fatigue continue even with
medication, leading to a worsening of the condition.

The Ventura Study is researching an add-on investigational medication, which
participants will take together with their ongoing antidepressant medication.
The primary goal of this study is to see if the investigational medication works
in adults with MDD and moderate-to-severe anhedonia (loss of pleasure or
interest) to improve depression symptoms.

Participants will receive either the investigational medication or a placebo
(both referred to as study medication). A placebo looks the same as the
investigational medication but does not contain any active ingredients. Neither
you nor the study doctor will know if you are taking the placebo or the
investigational medication.

The study medication will be provided as 10 mg capsules to be taken by mouth
once a day for 6 weeks. Participants who complete the 6-week treatment period in
the Ventura Study may be eligible to participate in a 1-year extension study.


WHAT TO EXPECT

Participants will need to visit the study center and have remote contact visits
by telephone.


Several tests and assessments will be performed to monitor the participant’s
health. These will include:

 * Questionnaires and interviews about your health, major depressive disorder,
   and your current medication.
 * Physical examinations.
 * Measurements of vital signs (blood pressure, heart rate and breathing rate).
 * Blood and urine samples.




THE STUDY PERIODS

This study is made up of 3 phases.

1

SCREENING PHASE

(up to 30 days)

You will visit the study center 1–2 times to see if the study is right for you
and whether you want to take part.

--------------------------------------------------------------------------------

2

STUDY TREATMENT PHASE

(6 weeks)

During this phase, you will take the study medication as a capsule by mouth once
every day. You will visit the study center 4 times for study assessments and
have 3 remote contact visits to check on your health. 

--------------------------------------------------------------------------------

3

FOLLOW-UP PHASE

(1-2 weeks)

After you have finished taking the study medication, you will visit the study
center once last time for final study assessments.

You may be able to take part in an optional 1-year extension study, where all
participants will receive the study medication. If you join this extension
study, you will not need to complete the follow-up visit in the short-term
study.


WHO CAN
TAKE PART?

You may be eligible to participate in the Ventura Study if you:

 * are between 18 and 74 years of age
 * have been diagnosed with major depressive disorder (MDD)
 * have not responded to at least 1 oral antidepressant
 * have been receiving, for at least 6 weeks, either:
   * a selective serotonin reuptake inhibitor (SSRIs) such as fluoxetine,
     citalopram, escitalopram, paroxetine, fluvoxamine, or sertraline (other
     SSRIs are acceptable) OR
   * serotonin-noradrenaline reuptake inhibitors (SNRIs) such as duloxetine,
     venlafaxine, desvenlafaxine, milnacipran.

You must meet all other study criteria to take part in the Ventura Study. You
can find more information about the study on the clinicaltrials.gov website.

 * Ventura 1 Study
 * Ventura 2 Study

Note that the eligibility criteria for both Ventura 1 and Ventura 2 are the same
and if you pre-qualify for participation, you will be referred to a study center
base on your location.


FREQUENTLY ASKED QUESTIONS

What is a clinical research study?

A clinical research study, also called a clinical trial or research study, is a
carefully designed scientific evaluation of an investigational medication.
Clinical research studies are conducted by doctors and researchers. A clinical
research study helps to answer important questions about an
investigational medication, such as:

 * How safe is the investigational medication?
 * Does it work?

What is an investigational medication?

An investigational medication or a study medication, has been tested in a
laboratory. Based on those results, an investigational medication may or may not
move forward to the next phase of testing in people. An investigational
medication also may be a medication that is approved for the treatment of one
disease or condition but is still under investigation in other diseases or
conditions. An investigational medication can only be used in clinical research
studies.

All investigational medications must be tested in clinical research studies
before they can be approved by health regulatory authorities to be prescribed to
patients. We need people to take part in clinical research studies so that new
medications can be developed.

After reading all the information on this website, I still have questions about
trying an investigational medication that may not work. Can you give me more
information?

There are always risks and benefits of participating in a clinical research
study. There is always a chance that an investigational medication could cause
side effects or will not work. However, you should know that there are strict
rules in place to monitor the safety of people taking part in a study. Before
joining any clinical research study, it is important to consider the risks and
understand them.

The study team will explain all the risks and benefits at the first study visit.
Throughout the study, a team of doctors and nurses will monitor the health of
the people taking part. They will be there to answer any questions you may have.

What happens after a decision is made to take part in the study?

If you would like to know whether you or your loved one might be able to take
part in the study, please fill out the form. If you or your loved one
pre-qualify, we will connect you or your loved one to a clinical research study
center in your area or your loved one’s area. We will also help schedule the
first study appointment at the study center. Please note: During the screening
process, the study doctor or study team will check additional criteria before
someone can join the study.

Is there a cost to take part?

If you qualify and participate in the study, you will receive study medication
and study-required care at no cost. Reimbursement for study-required local
travel will be given.

Will participant confidentiality be protected?

All personal information will remain confidential, and data will only be
collected and used as necessary to support an individual’s match to and
participation in a study. Participants’ names will not be included in any data
reported. For more information, including how and why we process personal data,
please read our Privacy Policy.

Are clinical research studies safe?

A clinical research study is a medical study that looks at whether a study
medication, device, or vaccine is safe and effective. Clinical research studies
follow strict rules to help protect volunteers and are approved by institutional
review boards. 

To help you learn about the study, you will read a document called the Informed
Consent Form (ICF) and speak with the study doctor. “Informed Consent” is a
process to make sure you are fully informed before deciding to volunteer for a
clinical research study. You should ask any questions you may have, and talk
with the study doctor, your family, or others that you trust, until you
understand all details, including the risks and benefits of the study. If you
wish to participate, you will sign the ICF. You will not sign if you do not want
to volunteer. Even if you agree to volunteer, you can change your mind and leave
the study at any time, for any reason.

What else should someone thinking about taking part in a clinical study
consider?

It is a personal decision to take part. Participation in the study is voluntary.
Please also consider:

 * If a decision is made to participate, you or the person taking part can
   withdraw at any time during the study.
 * The study team will explain the possible benefits and risks of the study
   during the informed consent process.
 * A person does not have to join any study if they don’t want to.
 * A team of doctors and nurses will carefully monitor the health of people
   taking part during the study.
 * The study medications will be provided at no cost.
 * There is the risk you will experience side effects or the study medication
   will not work.
 * Taking part in the study may help other people with major depressive disorder
   in the future.

People taking part in the study will need to follow all the instructions from
the study doctor and nurses.


SEE IF YOU PRE-QUALIFY

The Ventura Study is open to people 18 to 74 years of age inclusive, with major
depressive disorder (MDD). Please answer the following questions to see if the
study is a good match.

IQVIA, our affiliates, and our service providers will use your responses to
these questions to determine your potential eligibility to participate in this
study. If you are found potentially eligible, we will share these responses and
the contact information that you provide with the investigator site that you
select. Our Privacy Policy further governs the use of the information that you
provide.

Questionnaire
Contact Info
Site Selection


The information you provide will only be used to determine if you, or someone
you know, might be eligible for the study.

The initial eligibility process, including this questionnaire, will take about
5–7 minutes.

See If You Pre-Qualify
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This website is hosted and operated by IQVIA on behalf of Janssen Research &
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This information is intended for use by United States residents who are 18 years
or older.

*In a clinical research study, participants may receive a study medication that
has not been approved by regulatory authorities, an approved comparator product
or intervention, or an inactive substance called a placebo, depending on study
design (all referred to as “study medication”). You may not benefit from the
study medication you are assigned to, and the key known risks and requirements
of participation in a study will be described to you before you decide whether
to take part. Depending on the study, compensation may be available as well as
reasonable reimbursement for travel expenses. The length of the study may vary.



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