- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00221494
Can Additional Drug Therapy Accelerate Response Time to Antidepressants
Can Additional Drug Therapy Accelerate Response Time to Antidepressants: A Double-blind, Placebo-controlled Randomization Research Study for Major Depression
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Major depression is an illness with substantial personal and economic morbidity (Greenberg et al.1993) and antidepressants are the cornerstone of treatment. As antidepressants usually require 3-6 weeks of use before a response occurs, an effective antidepressant acceleration strategy would reduce the time of onset for an effective antidepressant response. This has significant clinical implications, as it could lead to reduced symptom morbidity, potentially reduce health care cost (i.e. shorter hospital length of stay), and improve functional capacity and quality of life.
The goal of this study is to enhance our understanding of strategies that accelerate or produce a more rapid treatment response in depression. This could lead to reduced symptom morbidity, potentially reduce health care cost (i.e. shorter hospital length of stay), and improve functional capacity and quality of life.
The study goals are: 1.) To assess whether the simultaneous commencement of liothyronine or pindolol to an SSRI can accelerate the treatment response (i.e. faster rate of improvement), 2.) To assess whether the simultaneous commencement of liothyronine or pindolol to an SSRI can augment or enhance treatment response (i.e. greater reduction in depressive symptoms at end of study phase), adn 3.) To assess whether gender influences the acceleration of augmentation response rate of liothyronine or pindolol.
Undersøgelsestype
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90095
- UCLA Neuropsychiatric Institute
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients, male and female, between the ages of 18 to 65
- DSM-IV criteria for major depressive disorder
- No prior SSRI medication treatment (if a patient has discontinued a non-SSRI medication for side effects, they will not be excluded)
- Ability to be followed clinically for 6 weeks
- Each patient must understand the nature of the study and must sign an informed consent form
Exclusion Criteria:
- Severe suicidality (as defined by Beck Depression Inventory Question 9, responses 2 or 3)
- Major Axis I mental illness other than major depressive disorder
- Unstable medical health specifically cardiovascular disease, abnormal EKG, history of severe drug allergy, poorly controlled diabetes, and asthma (pindolol contraindication)
- History of thyroid disease or abnormal TFT's (stage I or II)
- Need for adjunctive antipsychotic use or additional benzodiazepine during the study
- Pregnancy
- Seizure disorder
- A positive urine toxicology screen
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Dobbelt
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mark A Frye, MD, University of California, Los Angeles
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Adfærdsmæssige symptomer
- Psykiske lidelser
- Stemningsforstyrrelser
- Depression
- Depressiv lidelse
- Lægemidlers fysiologiske virkninger
- Adrenerge beta-antagonister
- Adrenerge antagonister
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Antihypertensive midler
- Vasodilatorer
- Psykotropiske stoffer
- Serotoninoptagelseshæmmere
- Neurotransmitter optagelseshæmmere
- Membrantransportmodulatorer
- Serotoninmidler
- Antidepressive midler
- Serotonin-antagonister
- Antidepressive midler, anden generation
- Citalopram
- Pindolol
Andre undersøgelses-id-numre
- 00-09-045-11
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