Status:
COMPLETED
Pharmacodynamics and Pharmacokinetics of Citalopram and Escitalopram
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
National Center for Research Resources (NCRR)
Conditions:
Depression
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
This study is one component of a larger U01 grant that was submitted in August, 2004 to the NIGMS as part of the Pharmacogenomic Research Network. This study will enroll 1200 patients over 4 years. I...
Eligibility Criteria
Inclusion
- Outpatients or inpatients with nonpsychotic MDD.
- A score of \>14 on the HRS-D17 (equivalent to 10 or greater on PHQ-9 which is used in primary care to assess depression) given that when medication exceeds the effect of placebo in primary care participants have a HRS-D17 \>12. We added 2 HRS-D17 points to take into account the possibility of measurement error.
- Outpatients or inpatients for whom antidepressant treatment is deemed appropriate by the treating clinician.
- Subjects who are between 18-85 years of age.
- Participants who have general medical conditions (GMCs) which could conceivably be physiologically causing their depressive symptoms will receive treatment as usual for their GMCs as well as for their MDD.
Exclusion
- Subjects with medical contraindications that preclude citalopram or escitalopram treatment and those who have previously failed to respond to citalopram or escitalopram will be excluded. In addition, patients with schizophrenia, schizoaffective disorder, or who have Bipolar I disorder will be excluded because they have a primary psychiatric condition that requires a different initial treatment. Subjects currently on antidepressant medication with subtherapeutic results in terms of depression management will undergo a medication taper and discontinuation prior to initiation of citalopram or escitalopram treatment. The subject will be closely monitored by the primary physician or psychiatrist during the medication taper and discontinuation phase. The medication taper is left upto the treating physician's or psychiatrist's discretion. Study subjects who cannot be safely tapered from their medication or experience adverse effects during the taper will be excluded from the study. Study subjects using their antidepressant medication for management of nicotine dependence, chronic pain, migraine prophylaxis or other diagnoses will not be eligible for the study. Trazodone, Melatonin, and Diphenhydramine may be used as rescue medications for insomnia. Benzodiazepines may be used for treatment of anxiety and atomoxetine may be used for the treatment of attention deficit disorder. Study subjects currently on antipsychotic medications (e.g., typical and atypical antipsychotic drugs) and mood stabilizing agents (e.g., lithium, carbamazepine, valproate, lamotrigine, gabapentin, or other anticonvulsants) are not eligible for the study with the exception of those starting quetiapine after baseline. Subjects unable to give informed consent are excluded. Pregnant subjects will be excluded.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
927 Patients enrolled
Trial Details
Trial ID
NCT00613470
Start Date
March 1 2005
End Date
May 1 2013
Last Update
December 18 2013
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905