Status:
COMPLETED
p11 Protein Levels in Patients With Major Depressive Disorder Treated With Citalopram
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Brief Summary
This study will compare levels of p11 protein in people with and without major depressive disorder (MDD) and examine if p11 levels in patients are affected by treatment with citalopram (Celexa). Heal...
Detailed Description
Major depressive disorder (MDD) is a serious, debilitating, life-shortening illness that affects many persons of all ages and backgrounds. While treatments are effective for a significant portion of p...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- CRITERIA FOR INCLUSION OF DEPRESSED PATIENTS:
- age 18-65 years
- written informed consent completed (consent-incapacitated subjects will not be eligible)
- score 20 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS)
- meets DSM-IV criteria for chronic or recurrent nonpsychotic MDD
- patients who are on non-excluded concomitant medications.
- no more than 3 failed antidepressant treatments within the current major depressive episode
- no alcohol use (last 7 days)
- ADDITIONAL CRITERIA FOR INCLUSION OF DEPRESSED PATIENTS FOR MRI IMAGING:
- age 18 55 years
- subjects must have either a family history of mood disorders, or have a history of
- multiple major depressive episodes
- age of onset of depressive symptoms less than 45 years
- no history of past alcohol or substance dependence (excluding nicotine) or alcohol or substance abuse (excluding nicotine) within the past year.
- no use of benzodiazepines within 2 weeks of either MRI scan
- CRITERIA FOR INCLUSION OF HEALTHY CONTROL SUBJECTS:
- age 18-65 years
- written informed consent completed
- no current or past diagnosis of axis I psychiatric disorder (DSM-IVTR)
- no alcohol use (last 7 days)
- physically healthy
- ADDITIONAL CRITERIA FOR INCLUSION OF HEALTHY CONTROL SUBJECTS FOR MRI IMAGING:
- age 18 55 years
- no history of past alcohol or substance dependence (excluding nicotine) or alcohol or substance abuse (excluding nicotine) within the past year.
- EXCLUSION CRITERIA:
- CRITERIA FOR EXCLUSION OF DEPRESSED PATIENTS:
- history of bipolar disorder (I, II, or NOS) (lifetime)
- history of schizophrenia
- history of schizoaffective disorder or
- psychosis NOS (lifetime)
- history of anorexia nervosa or bulimia nervosa (lifetime)
- current primary obsessive-compulsive disorder (OCD) or current post traumatic stress disorder (PTSD) whose onset preceded the onset of Major Depressive Disorder
- history of clear-cut intolerability to the study medication
- lack of response to an adequate trial of the study medication (citalopram) in the current or past episodes of MDD
- did not respond to 7 or more sessions of ECT in the current episode of MDD
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- has general medical condition which contraindicates the use of the study medication
- is on concomitant medication which contraindicates the use of the study medication
- requires immediate hospitalization for psychiatric disorder
- requires antipsychotic medications or mood stabilizers
- Non-postmenopausal (less than 2 years since last period) females of childbearing potential who are sexually active and who are not using adequate (hormonal, double barrier, surgical) contraception, or who are pregnant or breast feeding
- patients currently taking any of the exclusionary medications detailed in protocol (including antipsychotic medications, anticonvulsant medications, antidepressant medications, mood stabilizers, central nervous system stimulants) in the 2 weeks prior to Study Period II.
- patients taking thyroid medication for hypothyroidism may be included if they have been stable on the medication for greater than 3 months
- patients can participate in a modality of psychotherapy that is not targeting the symptoms of depression (e.g., supportive therapy, marital therapy)
- therapy that is depression specific, such as Cognitive Therapy (CT) or Interpersonal Psychotherapy of Depression (IPT) is not allowed during participation
- subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent.
- current alcohol dependence or abuse (last 3 months)
- patient has a prolonged QTc (greater than or equal to 450 msec), as shown on ECG
- Current NIMH employee/staff or their immediate family member.
- ADDITIONAL CRITERIA FOR EXCLUSION OF DEPRESSED PATIENTS FOR MRI IMAGING:
- subjects meeting general exclusion criteria for MRI scanning (e.g. implanted cardiac pacemaker, intraocular metal) will be excluded from the MRI procedures only.
- subjects with structural lesions visible on MRI will be excluded from further MRI procedures
- subjects with diabetes or hypertension will be excluded
- CRITERIA FOR EXCLUSION OF HEALTHY CONTROL SUBJECTS:
- subjects currently taking any of the exclusionary medications detailed in protocol in the 2 weeks prior to evaluation
- current alcohol dependence or abuse (last 3 months)
- history of major depression or bipolar disorder in any first degree relative
- ADDITIONAL CRITERIA FOR EXCLUSION OF HEALTHY CONTROL SUBJECTS:
- subjects meeting general exclusion criteria for MRI scanning (e.g. implanted cardiac pacemaker, intraocular metal) will be excluded from the MRI procedures only.
- subjects with structural lesions visible on MRI will be excluded from further MRI procedures
- subjects with diabetes or hypertension will be excluded
Exclusion
Key Trial Info
Start Date :
June 3 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 28 2016
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00697268
Start Date
June 3 2008
End Date
July 28 2016
Last Update
December 17 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892