Sonia Davis - Academia.edu (original) (raw)

Papers by Sonia Davis

Research paper thumbnail of Vagus Nerve Stimulation for Treatment-Resistant Depression: A Randomized, Controlled Acute Phase Trial

Biological Psychiatry, 2005

Background: Vagus nerve stimulation (VNS) alters both concentrations of neurotransmitters or thei... more Background: Vagus nerve stimulation (VNS) alters both concentrations of neurotransmitters or their metabolites and functional activity of central nervous system regions dysregulated in mood disorders. An open trial has suggested efficacy. Methods: This 10-week, acute, randomized, controlled, masked trial compared adjunctive VNS with sham treatment in 235 outpatients with nonpsychotic major depressive disorder (n ϭ 210) or nonpsychotic, depressed phase, bipolar disorder (n ϭ 25). In the current episode, participants had not responded adequately to between two and six research-qualified medication trials. A two-week, single-blind recovery period (no stimulation) and then 10 weeks of masked active or sham VNS followed implantation. Medications were kept stable. Primary efficacy outcome among 222 evaluable participants was based on response rates (Ն50% reduction from baseline on the 24-item Hamilton Rating Scale for Depression [HRSD 24 ]). Results: At 10-weeks, HRSD 24 response rates were 15.2% for the active (n ϭ 112) and 10.0% for the sham (n ϭ 110) groups (p ϭ .251, last observation carried forward [LOCF]). Response rates with a secondary outcome, the Inventory of Depressive Symptomatology -Self-Report (IDS-SR 30 ), were 17.0% (active) and 7.3% (sham) (p ϭ .032, LOCF). VNS was well tolerated; 1% (3/235) left the study because of adverse events. Conclusions: This study did not yield definitive evidence of short-term efficacy for adjunctive VNS in treatment-resistant depression.

Research paper thumbnail of National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer Disease Trial Methodology

American Journal of Geriatric Psychiatry, 2001

fectiveness of atypical antipsychotics for psychosis and agitation occurring in AD outpatients. T... more fectiveness of atypical antipsychotics for psychosis and agitation occurring in AD outpatients. They provide an overview of the methodology utilized in the trial as well as the clinical-outcomes and effectiveness measures that were implemented. (Am J Geriatr

Research paper thumbnail of Effect of concurrent anxiety on response to sertraline and imipramine in patients with chronic depression

Depression and Anxiety, 2001

Research paper thumbnail of Decision-making capacity for research participation among individuals in the CATIE schizophrenia trial

Schizophrenia Research, 2005

Uncertainty regarding the degree to which persons with schizophrenia may lack decision-making cap... more Uncertainty regarding the degree to which persons with schizophrenia may lack decision-making capacity, and what the predictors of capacity may be led us to examine the relationship between psychopathology, neurocognitive functioning, and decision-making capacity in a large sample of persons with schizophrenia at entry into a clinical trial.In the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial, a clinical trial sponsored by the National Institute of Mental Health designed to compare the effectiveness of antipsychotic drugs, subjects were administered the MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) and had to demonstrate adequate decision-making capacity before randomization. The MacCAT-CR, the Positive and Negative Syndrome Scale (PANSS), and an extensive neurocognitive battery were completed for 1447 study participants.The neurocognitive composite score and all 5 neurocognitive subscores (verbal memory, vigilance, processing speed, reasoning, and working memory) were positive correlates of the MacCAT-CR understanding, appreciation, and reasoning scales at baseline. Higher levels of negative symptoms, but not positive symptoms, were inversely correlated with these three MacCAT-CR scales. Linear regression models of all three MacCAT-CR scales identified working memory as a predictor; negative symptoms made a small contribution to the understanding and appreciation scores.Negative symptoms and aspects of neurocognitive functioning were correlated with decision-making capacity in this large sample of moderately ill subjects with schizophrenia. In multiple regression models predicting performance on the MacCAT-CR scales, working memory was the only consistent predictor of the components of decision-making capacity. Individuals with schizophrenia who have prominent cognitive dysfunction, especially memory impairment, may warrant particular attention when participating in research.

Research paper thumbnail of Vagus Nerve Stimulation for Treatment-Resistant Depression: A Randomized, Controlled Acute Phase Trial

Biological Psychiatry, 2005

Background: Vagus nerve stimulation (VNS) alters both concentrations of neurotransmitters or thei... more Background: Vagus nerve stimulation (VNS) alters both concentrations of neurotransmitters or their metabolites and functional activity of central nervous system regions dysregulated in mood disorders. An open trial has suggested efficacy. Methods: This 10-week, acute, randomized, controlled, masked trial compared adjunctive VNS with sham treatment in 235 outpatients with nonpsychotic major depressive disorder (n ϭ 210) or nonpsychotic, depressed phase, bipolar disorder (n ϭ 25). In the current episode, participants had not responded adequately to between two and six research-qualified medication trials. A two-week, single-blind recovery period (no stimulation) and then 10 weeks of masked active or sham VNS followed implantation. Medications were kept stable. Primary efficacy outcome among 222 evaluable participants was based on response rates (Ն50% reduction from baseline on the 24-item Hamilton Rating Scale for Depression [HRSD 24 ]). Results: At 10-weeks, HRSD 24 response rates were 15.2% for the active (n ϭ 112) and 10.0% for the sham (n ϭ 110) groups (p ϭ .251, last observation carried forward [LOCF]). Response rates with a secondary outcome, the Inventory of Depressive Symptomatology -Self-Report (IDS-SR 30 ), were 17.0% (active) and 7.3% (sham) (p ϭ .032, LOCF). VNS was well tolerated; 1% (3/235) left the study because of adverse events. Conclusions: This study did not yield definitive evidence of short-term efficacy for adjunctive VNS in treatment-resistant depression.

Research paper thumbnail of National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer Disease Trial Methodology

American Journal of Geriatric Psychiatry, 2001

fectiveness of atypical antipsychotics for psychosis and agitation occurring in AD outpatients. T... more fectiveness of atypical antipsychotics for psychosis and agitation occurring in AD outpatients. They provide an overview of the methodology utilized in the trial as well as the clinical-outcomes and effectiveness measures that were implemented. (Am J Geriatr

Research paper thumbnail of Effect of concurrent anxiety on response to sertraline and imipramine in patients with chronic depression

Depression and Anxiety, 2001

Research paper thumbnail of Decision-making capacity for research participation among individuals in the CATIE schizophrenia trial

Schizophrenia Research, 2005

Uncertainty regarding the degree to which persons with schizophrenia may lack decision-making cap... more Uncertainty regarding the degree to which persons with schizophrenia may lack decision-making capacity, and what the predictors of capacity may be led us to examine the relationship between psychopathology, neurocognitive functioning, and decision-making capacity in a large sample of persons with schizophrenia at entry into a clinical trial.In the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial, a clinical trial sponsored by the National Institute of Mental Health designed to compare the effectiveness of antipsychotic drugs, subjects were administered the MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) and had to demonstrate adequate decision-making capacity before randomization. The MacCAT-CR, the Positive and Negative Syndrome Scale (PANSS), and an extensive neurocognitive battery were completed for 1447 study participants.The neurocognitive composite score and all 5 neurocognitive subscores (verbal memory, vigilance, processing speed, reasoning, and working memory) were positive correlates of the MacCAT-CR understanding, appreciation, and reasoning scales at baseline. Higher levels of negative symptoms, but not positive symptoms, were inversely correlated with these three MacCAT-CR scales. Linear regression models of all three MacCAT-CR scales identified working memory as a predictor; negative symptoms made a small contribution to the understanding and appreciation scores.Negative symptoms and aspects of neurocognitive functioning were correlated with decision-making capacity in this large sample of moderately ill subjects with schizophrenia. In multiple regression models predicting performance on the MacCAT-CR scales, working memory was the only consistent predictor of the components of decision-making capacity. Individuals with schizophrenia who have prominent cognitive dysfunction, especially memory impairment, may warrant particular attention when participating in research.