• What is Treatment Resistant Depression?

• What does the study involve?

• What kind of study is the TORDIA study?

• Will I know the treatment my son/daughter is getting?

• Are parents involved in this study?

• Are any medications used in this study experimental?

• Hasn't there been recent concern regarding the use of antidepressants by Children and adolescents and a potential increase in suicidality?

• Who do I contact to find out more about TORDIA

What is Treatment Resistant Depression?

Many teens treated for depression do not get better with the first treatment and will need a change in the type of treatment they are receiving in order to feel better. This type of depression is termed "treatment resistant."

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What does the study involve?

Volunteers who participate in this study will be randomly assigned to take
one of three antidepressant medications: Prozac(fluoxetine), Celexa (citalopram), or Effexor XR (venlafaxine ER) either alone or in combination with a type of psychotherapy called cognitive behavioral therapy (CBT). Participants also will be closely monitored for 12 weeks. Participants who show a clinically acceptable response will receive 12 additional weeks of continuation treatment with the same intervention as in the initial 12 weeks. Non-responders will be offered 12 weeks of open treatment. All participants will receive follow-up psychiatric evaluations for 12 months after the continuation treatment regardless of treatment compliance. If at any time during the study there is little or no improvement or symptoms worsen, the participant may be withdrawn from the study and offered other treatment options. From beginning to end, the study lasts 18 1/2 months for each participant.

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What kind of study is the TORDIA study?

The TORDIA Study is called a "double blind randomized clinical trial."

TORDIA is a "double blind" study because everyone participating in the study will be taking a study medication but you, your child, and your family will not know which medication your child is taking. Additionally, neither your child's doctor, interviewer, medication nurse, nor therapist will know which medication your child has been given. In case of an emergency, however, the medication name your child is assigned will be kept by the study staff in a sealed envelope in the study office as well as the Emergency Room. The research pharmacist who dispenses the study medication will also know the medication and dose that your child is taking.

We call TORDIA "randomized" because the intervention that your child is assigned will be determined by a computer program that randomly selects the study intervention your child will receive. In other words, this computer program will randomly select one of three potential study medications (Prozac, Celexa, or Effexor XR) your child will receive with or without cognitive behavioral therapy (CBT).

TORDIA is a "Clinical trial" because it is a study to test the
effectiveness of medications. As a clinical trial, the TORDIA study is regulated by each site's Institutional Review Board (IRB), United States (U.S.) Department of Health and Human Services (DHHS), and the U.S. Food and Drug Administration (FDA). The TORDIA Study is sponsored (e.g. funded) by the National Institute of Mental Health (NIMH) which is part of the National Institute of Health (NIH)

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Will I know the treatment my son/daughter is getting?

Not exactly. TORDIA is "double blind" clinical trial because everyone participating in TORDIA will be taking either citalopram (Celexa), fluoxetine (Prozac), or venlafaxine(Effexor XR), but you, your child, and your family will not know which medication your child is taking. Additionally, neither your child's doctor, interviewer, medication nurse, nor therapist will know which medication your child has been given. You, your child, your child's study doctor, nurse, and therapist (if assigned) will know if you are getting therapy or not. The study interviewer, however, will not. In summary, you and your child will know your child is getting one of three medications (and therapy if assigned).

In case of an emergency, the medication assigned to your child will be kept by the study staff in a sealed envelope in the research office as well as the Emergency Room. The research pharmacist who dispenses the study medication also will know the medication and dose that your child will be taking.

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Are parents involved in this study?

Yes. Parents will be asked to fill out some questionnaires and participate in the assessments at the beginning, middle, and end of the study. You will be asked to help your child take his/her medication and to keep a record of when your child is taking it. Also, when your child meets with the doctor or nurse for his/her medication appointments, the nurse or doctor will ask you how you think your child is doing after they have talked with your child. If your child is receiving therapy, you may be asked to join a few sessions with your child and his/her therapist.

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Are any medications used in this study experimental?

Everyone participating in the study will be taking either citalopram (Celexa), fluoxetine (Prozac), or venlafaxine ER (Effexor XR). Prozac, Celexa, and Effexor XR have all been approved by the U.S. Food and Drug Administration (FDA) for treatment of depression in adults. However, only Prozac has been FDA approved for treating depression in adolescents. Therefore, the drugs Celexa and Effexor XR used in this research study are considered "investigational/experimental" because the Food and Drug Administration (FDA) has not approved them for use in the treatment of depression in children and adolescents.

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Hasn't there been recent concern regarding the use of antidepressants by Children and adolescents and a potential increase in suicidality?

Yes. The U.S. Food and Drug Administration (FDA) has determined that the use of antidepressants pose a slightly increased risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders. The FDA reviewed 24 studies conducted comparing antidepressants to placebo, involving a total of 4400 children and adolescents. They found a slightly increased risk of suicidal thoughts (defined as having thoughts of wanting to kill oneself) and behavior (defined as trying to kill oneself) among patients taking antidepressants compared to those taking placebo (a sugar pill). The rate of suicidality was 4% (4 out of 100) in the medication group compared to 2% (2 out of 100)in the placebo group. For every 100 children who are given medication and 100 children who are given placebo, 2 more children will become suicidal in the medication group than in the placebo group. Fortunately, none of the children in these studies actually committed suicide. This slightly increased risk of suicidal thinking and behavior for children and adolescents taking an antidepressant was found for the types of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin and Norepinephrine Reuptake Inhibitors(SNRIs). These types of antidepressants include the medications used in this study (Celexa, Prozac, and Effexor XR) as well as other antidepressants including Zoloft(sertaline), Luvox (fluvoxamine), or Lexapro(escitalopram).

Before using these study medications (Celexa, Prozac, or Effexor XR), you, your child, and your study physician and nurse will talk about the reasons why the study medications are being considered and the potential side- effects. Throughout the study, we will monitor your child closely for the emergence of symptoms that may be associated with an increased risk for suicidal thinking and behavior. These symptoms include worsening depression, mania, agitation, irritability, suicidal statements/behaviors and/or any unusual changes in behavior. This monitoring is most important during the initial few months of treatment, as well as during times in which the study medication dose is being changed. We will also teach you and your child about how to watch for these side effects, and what to do if problems occur. If these problems do occur, you and your child should immediately call the TORDIA Study emergency contact number provided by your study location. This is because symptoms such as these may indicate a need for very close monitoring of your child and possibly changes in his/her study medication. Additionally, it is very important that your child continue to participate in regularly scheduled study appointments.

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Who do I contact to find out more about TORDIA?

Who you call depends on where you live. Check out our study locations to see if there is a location near you. If you live in one of the areas listed, you can call the phone number given for that location or call toll free at 1-866-666-2538. All calls are confidential.

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