Mechanisms of Antidepressant Non-Response in Late-Life Depression
Fjalë kyçe
Abstrakt
Përshkrim
To determine whether decreased antidepressant medication response in LLD patients with ED and WMH is caused by a loss of expectancy effects, Investigators will evaluate 130 outpatients with LLD at baseline to determine their degree of ED (interference score on Stroop Color-Word Test), WMH burden (severity score on Fazekas modified Coffey Rating Scale derived from anatomical MRI), and white matter tract integrity (using diffusion tensor imaging [DTI]). Building on work from the investigators K23 Award, the investigator will manipulate participants' expectancy of improvement in an 8-week duration antidepressant trial by randomizing patients between open administration of escitalopram (i.e., high expectancy) and placebo-controlled administration of escitalopram (i.e., low expectancy). The difference in antidepressant response observed between open and placebo-controlled medication treatment is a measure of the expectancy contribution to outcome, which is substantial in younger depressed adults but investigators hypothesize this will be diminished in LLD patients with ED and WMH.
Datat
Verifikuar së fundmi: | 05/31/2020 |
Paraqitur së pari: | 08/25/2013 |
Regjistrimi i vlerësuar u dorëzua: | 08/25/2013 |
Postuar së pari: | 08/28/2013 |
Përditësimi i fundit i paraqitur: | 06/29/2020 |
Përditësimi i fundit i postuar: | 07/01/2020 |
Data e paraqitjes së rezultateve të para: | 03/06/2020 |
Data e paraqitjes së parë të rezultateve të QC: | 04/05/2020 |
Data e rezultateve të para të postuara: | 04/07/2020 |
Data e fillimit të studimit aktual: | 02/18/2014 |
Data e vlerësuar e përfundimit primar: | 01/16/2019 |
Data e vlerësimit të përfundimit të studimit: | 01/16/2020 |
Gjendja ose sëmundja
Ndërhyrja / trajtimi
Drug: Escitalopram
Drug: Double Blind-Placebo
Faza
Grupet e krahëve
Krah | Ndërhyrja / trajtimi |
---|---|
Placebo Comparator: Double Blind-Placebo Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day. | Drug: Double Blind-Placebo Inert substance or treatment which is designed to have no therapeutic value but resemble the active medication in this study |
Active Comparator: Double Blind-Escitalopram Blinded treatment with either escitalopram 10mg, increased to escitalopram 20mg at week 4 if depression has not remitted. | |
Active Comparator: Open Treatment with Escitalopram Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4. |
Kriteret e pranimit
Moshat e pranueshme për studim | 60 Years Për të 60 Years |
Gjinitë e pranueshme për studim | All |
Pranon Vullnetarë të Shëndetshëm | po |
Kriteret | Inclusion Criteria: - Men and women aged 60-90 years - Diagnosis with nonpsychotic Diagnostic and Statistical Manual (DSM) IV MDD - 24-item Hamilton Rating Scale for Depression (HRSD) score ≥ 16 - Willing to and capable of providing informed consent and complying with study procedures Exclusion Criteria: - Current comorbid Axis I DSM IV disorder other than Nicotine Dependence, Adjustment Disorder, or Anxiety Disorder - diagnosis of substance abuse or dependence (excluding Nicotine Dependence) within the past 12 months - History of psychosis, psychotic disorder, mania, or bipolar disorder - Diagnosis of probable Alzheimer's Disease, Vascular Dementia, or Parkinson's Disease - MMSE < 24 - HRSD suicide item > 2 or Clinical Global Impressions (CGI)-Severity score of 7 at baseline - history of allergic or adverse reaction to escitalopram, or non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20mg) during the current episode - current treatment with psychotherapy, antidepressants, antipsychotics, or mood stabilizers - having contraindication to MRI scanning (such as metal in body) or unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia) - acute, severe, or unstable medical or neurological illness |
Rezultati
Masat Kryesore të Rezultateve
1. Hamilton Rating Scale for Depression (HRSD) [Baseline]
Masat dytësore të rezultateve
1. Hamilton Rating Scale for Depression (HRSD) [Week 8]
2. Quick Inventory of Depressive Symptoms (QIDS-SR) [Baseline]
3. Quick Inventory of Depressive Symptoms (QIDS-SR) [Week 8]
4. Credibility and Expectancy Scale-Better (CES) [Pre-Baseline]
5. Credibility and Expectancy Scale-Better (CES) [Week 0]
6. Credibility and Expectancy Scale-Depression [Pre-baseline]
7. Credibility and Expectancy Scale-Depression [Week 0]
8. Quick Inventory of Depression Scale (QIDS-SR): Expectancy [Pre-Baseline]
9. Quick Inventory of Depression Scale (QIDS-SR): Expectancy [Week 0]
10. Executive Dysfunction: Stroop Color Word [Pre-Baseline]
11. Executive Dysfunction: Stroop Interference [Pre-Baseline]
12. White Matter Hyperintensity (WMH) Outcome- Total WMH [Pre-Baseline]