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An Investigation to Determine Whether Levels of P11 Protein in Peripheral Blood Cells Correlate with Treatment Response to Citalopram in Patients with Major Depressive Disorder
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
08-M-0150 |
Sponsoring Institute |
National Institute of Mental Health (NIMH) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Depression; |
Recruitment Keyword(s) |
Major Depression; |
Condition(s) |
Depression |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
Healthy normal volunteers and patients with chronic or recurrent major depression between 18 and 65 years of age may be eligible for this study.
Participants undergo the following tests and procedures:
Healthy Volunteers
-Psychiatric interview and medical examination, questions about family history
-Blood draw
Patients with MDD
Phase 1 - Evaluation and Discontinuation of Medications
-Physical examination, electrocardiogram, blood tests
-Gradual antidepressant medication withdrawal, followed by 2- to 6-week drug-free period. If needed, medicines for anxiety and difficulty sleeping may be prescribed.
Phase 2 - Citalopram Treatment
-Start daily citalopram treatment
-Evaluations at the start of phase 2 and every week for 8 weeks with following procedures:
-Symptoms ratings interview and questionnaires
-Review of side effects and new medications
-Blood pressure and pulse measurements
-Blood and urine tests
At the end of the study, plans are developed for long-term treatment and transfer of care to the patient's own physician.
Eligibility
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
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
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information http://clinicalstudies.info.nih.gov. |
| Carlos A. Zarate, M.D. National Institute of Mental Health (NIMH) National Institutes of Health Building 10 Room B1D43 10 Center Drive Bethesda, Maryland 20892 (301) 451-8894 kreislw@mail.nih.gov |
Libby Jolkovsky National Institute of Mental Health (NIMH) National Institutes of Health Building 10 Room B1D43 10 Center Drive Bethesda, Maryland 20892 (301) 451-8894 kreislw@mail.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00697268
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