Department of Psychiatry

We are currently enrolling participants for a clinical research study to look at the effectiveness and safety of an investigational medication (given as a nasal spray) in patients with depression who have not responded to prior treatment with at least two antidepressants. If you are eligible for this study and choose to participate, you will receive all study visits and study-related medical care at no cost to you.

There are three phases in the study:

• A screening phase of up to 7 weeks
• A 4-week treatment phase
• A 24-week follow-up phase

Some patients will be given the option to continue treatment in another study and will not have a follow-up phase. Patients who do not have a follow-up phase will be in the study for 11 weeks; all other patients will be in the study for 35 weeks.

To be considered for this study, you must be:

• 18 to 64 years old
• Diagnosed with depression
• Experiencing depression symptoms despite having taken two antidepressant medications in the past
• Comfortable with using a nasal spray
• Able to provide written consent to participate in the study

The study doctor will discuss additional requirements for being in the study with you.

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This study is being conducted to evaluate the long-term maintenance effects of individuals treated with vortioxetine (aka, Brintellix) in the prevention of depression relapse. Participants will be enrolled into a 8-16 weeks open-label treatment period. During the open-label period, all subjects will receive 10 mg Vortioxetine. At the end of the open label patients have option to go into 16 -52 week, double blind study to assess the Efficacy and Safety of Vortioxetine (5, 10 and 20 mg) in Adults with MDD.

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We are looking for people who are currently experiencing major depressive episodes associated with bipolar I or bipolar II disorder to take part in our bipolar depression studies. These clinical research studies are designed to help us learn more about an investigational medication for symptoms of bipolar depression.

• The 401 Study is a randomized, double-blind, placebo-controlled  research study which is looking at whether an investigational medication, called ITI-007, can improve the symptoms of bipolar depression (bipolar I or bipolar II disorder). It also aims to look at how safe the investigational medication is and whether it impacts the quality of life and well-being of people with bipolar depression.

You may be able to take part in the 401 or 402 Study if you:

• are between 18 and 65 years of age (inclusive)
• have been diagnosed with bipolar I or bipolar II disorder
• are currently having a major depressive episode that started at least 2 weeks ago, but no more than
  6 months ago
• have previously had at least one bipolar manic episode or mixed episode (if you have bipolar I disorder) or hypomanic episode (if you have bipolar II disorder).

Study participation will last up to 12 weeks and will require nine visits to the study center.

Participate

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We are looking for people who are currently experiencing major depressive episodes associated with bipolar I or bipolar II disorder to take part in our bipolar depression studies. These clinical research studies are designed to help us learn more about an investigational medication for symptoms of bipolar depression.

• The 402 study is a randomized, double-blind, placebo-controlled research study which is looking at whether an investigational medication, called ITI-007, can improve the symptoms of bipolar depression (bipolar I or bipolar II disorder). It also aims to look at how safe the investigational medication is and whether it impacts the quality of life and well-being of people with bipolar depression, when it is added to existing treatment with a mood stabilizer, specifically lithium or valproate.

You may be able to take part in the 401 or 402 Study if you:

• are between 18 and 65 years of age (inclusive)
• have been diagnosed with bipolar I or bipolar II disorder
• are currently having a major depressive episode that started at least 2 weeks ago, but no more than
  6 months ago
• have previously had at least one bipolar manic episode or mixed episode (if you have bipolar I disorder) or hypomanic episode (if you have bipolar II disorder).

Study participation will last up to 12 weeks and will require nine visits to the study center.

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This study is being done to collect information related to Major Depressive Disorder (MDD). You will be asked to complete questionnaires about your symptoms and functioning, information about your daily activity and sleep quality, and provide speaking samples that will allow us to examine your speech and voice characteristics. All of these factors will be examined to see if any of them can be used to predict worsening of depression at some future time.

You will be in the study for about 13 months. The study is designed to follow all subjects until a total of 150 people have had a relapse (when all the symptoms of depression return).  Based on when this number is achieved, there may be a chance that you will be asked to participate for longer than 13 months, or shorter than 13 months.

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