Effects of Cognitive Behavioral Therapy on Brain Serotonin Activity in People With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will examine changes in brain serotonin activity in people with depression before
      and after they receive cognitive behavioral therapy.
    

Detailed description: 
      Depression is a serious illness that affects almost 19 million adults in the United States
      each year. Common symptoms of depression include persistent feelings of anxiety, guilt, or
      hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously
      enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability
      to concentrate. A person's depression can be attributed to a variety of causes, including
      biological and genetic factors, environmental influences, or developmental experiences. Among
      biological factors, a recently researched possible cause is the altered activity of
      specialized areas on brain nerve cells called serotonin receptors, which have been found to
      be at reduced levels in people with depression. The hormone serotonin is known to naturally
      influence mood, making depression treatments that aim to increase levels of serotonin
      important. Treatment for depression with cognitive behavioral therapy (CBT), which teaches
      ways to modify thoughts and behaviors that contribute to depression, may help in raising
      brain serotonin levels and in improving depressive symptoms. This study will examine changes
      in brain serotonin activity using single photon emission computed tomography (SPECT) imaging
      in people with depression before and after they receive CBT. The study will also use SPECT
      imaging to compare brain serotonin activity of non-depressed healthy participants with that
      of depressed participants.

      Participation in this study will last between 12 and 14 weeks. All participants will first
      undergo an initial evaluation that will include questions about medical history, a physical
      exam, a blood draw, a urine test, and an electrocardiogram (ECG). Participants will then
      undergo an ADAM (a selective radioligand for SPECT imaging) SPECT scan. During the ADAM SPECT
      scan visit, participants will undergo an injection of the ADAM, an ECG, blood pressure
      monitoring, and a 60-minute SPECT scan. If necessary, participants may also be asked to have
      a magnetic resonance imaging (MRI) brain scan after completing the SPECT scan.

      Depressed participants will then attend at least once weekly CBT sessions for 12 weeks.
      During the 45-minute sessions, participants will meet with a therapist to learn ways to
      adjust thoughts and behaviors that may be adding to their depression. After completing the 12
      weeks of CBT, all participants will be re-evaluated by a study doctor and, if still in good
      health, will undergo a repeat ADAM SPECT scan.
    

Intervention name(s): ADAM SPECT plus Cognitive Therapy; ADAM SPECT plus No Therapy
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: SPECT Brain Imaging; Cognitive Therapy; Serotonin Transporter Binding; Predictive Biomarker