Major Depressive Disorder Clinical Trial
Official title:
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:
1. All depressed subjects, when compared with normal controls, will present lower baseline
levels of compounds characteristic for the high-energy phosphate metabolism.
2. 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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2004 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Alliance for Research on Schizophrenia and Depression |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in depression (as measured by Ham-D-17) over the 4 weeks study | 4 weeks | ||
Secondary | change in bioenergetic metabolism (e.g., NTP and PCr) as measured by phosphorus magnetic resonance spectroscopy (P31-MRS) | 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05537558 -
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
|
||
Terminated |
NCT02192099 -
Open Label Extension for GLYX13-C-202, NCT01684163
|
Phase 2 | |
Completed |
NCT03142919 -
Lipopolysaccharide (LPS) Challenge in Depression
|
Phase 2 | |
Recruiting |
NCT05547035 -
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
|
N/A | |
Terminated |
NCT02940769 -
Neurobiological Effects of Light on MDD
|
N/A | |
Recruiting |
NCT05892744 -
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
|
Phase 4 | |
Recruiting |
NCT05537584 -
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
|
Phase 4 | |
Active, not recruiting |
NCT05061706 -
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT04479852 -
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
|
Phase 2 | |
Recruiting |
NCT04032301 -
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
|
Phase 1 | |
Recruiting |
NCT05527951 -
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
|
N/A | |
Completed |
NCT03511599 -
Cycloserine rTMS Plasticity Augmentation in Depression
|
Phase 1 | |
Recruiting |
NCT04392947 -
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
|
N/A | |
Recruiting |
NCT05895747 -
5-HTP and Creatine for Depression R33 Phase
|
Phase 2 | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Recruiting |
NCT05813093 -
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
|
N/A | |
Recruiting |
NCT05135897 -
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
|
||
Enrolling by invitation |
NCT04509102 -
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
|
Early Phase 1 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A | |
Recruiting |
NCT06026917 -
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
|
Phase 4 |