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Advancing personalized antidepressant treatment using PET/MRI

Sponsored by Stony Brook University

Phase Quota
Phase 4

Despite current medications, morbidity and mortality of Major Depressive Disorder (MDD) remain high. According to the World Health Organization, MDD affects 121 million people worldwide, and is projected to be the second leading cause of global disability by 2020. Monotherapy with SSRIs is the most widely used treatment for MDD. However, on average, SSRIs require six weeks for onset of action, and two-thirds of those on SSRIs fail to achieve remission.Compounding this problem, patients with residual symptoms are significantly more likely to discontinue treatment or relapse, be hospitalized for medical and psychiatric conditions, or die of suicide and other causes. Although eliminating ineffective treatment trials would significantly reduce patient suffering and healthcare costs,clinicians currently do not have the tools to objectively select treatment based on an individual's likelihood of remission. Therefore, there is an urgent need to identify markers predictive of an individual's SSRI treatment outcome. Developing this personalized treatment requires increased understanding of the relationship between pretreatment neurobiology, SSRI-induced biological changes, and the corresponding symptom improvements.

Study Start Date: May 2015

Estimated Completion Date: May 2019

Specialties: Internal Medicine: Clinical Pharmacology,Psychiatry Psychiatry: Neuro/Psych Pharmacol

Interventions

  • Drug: Escitalopram
  • Drug: Placebo

Inclusion criteria

  • Age range 21-55 years
  • Capacity to consent
  • Diagnosis of MDD and suffering from a major depressive episode
  • Score of at least 22 on the MADRS

Exclusion criteria

  • Significant active physical illness, particularly those that may affect the brain
  • Patients considered at significant risk for suicide
  • Patient is unlikely to be able to tolerate medication washout. Medication washouts will be supervised by a study physician
  • For females: Pregnancy, currently lactating; planning to conceive during the course of study participation, or abortion in the past two months
  • Blood donation within the past eight weeks
  • Anticoagulant or anti-platelet treatment, other than aspirin, within 10 days of PET scanning
  • Current, past, or anticipated significant exposure to radiation, that may include:
    • Being badged for radiation exposure in the workplace
    • Participation in nuclear medicine procedures, including research protocols in the last year*
  • Any MRI contraindications, including history of claustrophobia, metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel
  • Bipolar Disorder
  • Lifetime history of psychosis
  • Current drug or alcohol dependence or abuse (excluding nicotine) - within 6 months for dependence, 2 for abuse; absence of lifetime IV drug use or ecstasy use more than two times
  • Currently taking effective antidepressant
  • Prior treatment in current episode with escitalopram (ESC) for ≥  4 weeks taking ≥ 2/3 PDR maximal dose
  • Prior intolerance of escitalopram (ESC)
  • Use of fluoxetine in past 5 weeks
  • History of head trauma with prolonged loss of consciousness (>10 minutes), or any neurological condition including stroke or seizure (excluding a single childhood febrile seizure) or a history of migraine headaches as determined by a physician
  • Currently on psychoactive medication deemed to be necessary (e.g., anticonvulsants, antidepressants, antipsychotics, corticosteroids and beta-blockers); Use of hypnotics less than 3X week will be allowed
  • ECT within the past 6 months

Study Locations And Contact Information

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