- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00562367
Biochemical Brain Changes Correlated With The Antidepressant Effect Of Thyroid Hormones
We propose to investigate structural and biochemical brain abnormalities in depressed subjects, and the relationship between the presence of such abnormalities and treatment outcome. We will recruit N=20 subjects with major depression disorder and N=20 matched normal controls. The depressed subjects would have previously not responded to an adequate trial with a selective serotonin reuptake inhibitor (SSRI). These depressed subjects will be treated for 4 weeks with the same SSRI antidepressant and with adjuvant triiodothyronine (T3). Structural magnetic resonance images (MRI) and then Phosphorus-31 magnetic resonance spectroscopic imaging (31P-MRSI) data will be obtained two times for each patient (at the beginning and at the end of the study) and one time for the normal controls. We will measure for each depressed subject the number of white matter hyperintensities (WMH); we will also measure the degree of change from baseline in several compounds characteristic for the cellular high-energy phosphate metabolism: the phosphocreatine/inorganic phosphate ratio and the beta-nucleoside triphosphate. We will compare the severity of WMH and the high-energy phosphate metabolism in two groups of depressed subjects (those responding and those not responding to thyroid hormone augmentation) and the normal controls.
We hypothesize that:
- All depressed subjects, when compared with normal controls, will present lower baseline levels of compounds characteristic for the high-energy phosphate metabolism.
- Depressed subjects responding to T3 augmentation, when compared with subjects not responding to T3 augmentation, will present a larger increase of the high-energy phosphate metabolism.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- DSM-IV diagnostic criteria for MDD (diagnosed with the use of SCID)
- Written informed consent
- Men or women aged 18-65
- A baseline Hamilton-D17 score of > 16.
Exclusion Criteria:
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy)
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- History of seizure disorder,
- History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months.
- History or current diagnosis of dementia, or a score of < 26 on the Mini Mental Status Examination (Folstein, 1975) at the screening visit.
- History of multiple adverse drug reactions or allergy to the study drugs.
- Patients with mood congruent or mood incongruent psychotic features.
- Patients having shown minimal or no response to a standard course of antidepressant treatment with an SSRI. A standard course will be defined as the following medications taken for > 4 weeks: fluoxetine > 20 mg/day, sertraline > 50 mg/day, paroxetine > 20 mg/day, fluvoxamine > 50 mg/day, citalopram > 20 mg/day, venlafaxine > 150 mg/day.
- Clinical or laboratory evidence of hypothyroidism.
- Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding baseline.
- History of intolerance to Cytomel
- History of cardiac pathology or diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in depression (as measured by Ham-D-17) over the 4 weeks study
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in bioenergetic metabolism (e.g., NTP and PCr) as measured by phosphorus magnetic resonance spectroscopy (P31-MRS)
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Iosifescu DV, Nierenberg AA, Mischoulon D, Perlis RH, Papakostas GI, Ryan JL, Alpert JE, Fava M. An open study of triiodothyronine augmentation of selective serotonin reuptake inhibitors in treatment-resistant major depressive disorder. J Clin Psychiatry. 2005 Aug;66(8):1038-42. doi: 10.4088/jcp.v66n0812.
- Iosifescu DV, Bolo NR, Nierenberg AA, Jensen JE, Fava M, Renshaw PF. Brain bioenergetics and response to triiodothyronine augmentation in major depressive disorder. Biol Psychiatry. 2008 Jun 15;63(12):1127-34. doi: 10.1016/j.biopsych.2007.11.020. Epub 2008 Jan 22.
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2001-P-000836
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on Cytomel (liothyronine)
-
Northwell HealthNational Alliance for Research on Schizophrenia and DepressionCompleted
-
Johns Hopkins UniversityCompletedMultiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Primary ProgressiveUnited States
-
M.D. Anderson Cancer CenterTerminatedHypothyroidism | Brain TumorUnited States
-
Oregon Health and Science UniversityCompletedMultiple SclerosisUnited States
-
Mylan Pharmaceuticals IncCompletedHealthyUnited States
-
Virginia Commonwealth UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedHypothyroidism | Thyroid Cancer | Thyroid GoiterUnited States
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedSubclinical HypothyroidismUnited States
-
Jens FaberCompletedHeart Failure | Low T3 SyndromeDenmark
-
Ipe, LLCCompleted
-
Patrice PerronTheramed co.CompletedThyroid CancerCanada