17 research outputs found
Prediction of Treatment Response and Diagnosis in Psychiatry
The lack of diagnostic gold standards and the multiplicity of vantage points used to conceptualize mental illness renders psychiatric diagnostic and therapeutic approaches susceptible to individual and cultural biases. Developments in therapeutic approaches have often provided vantage points from which to conceptualize psychopathology. The identification of predictors of treatment response may be a useful element for clinicians to select between multiple treatment tools in an expanding therapeutic armamentarium while fostering refinements in current diagnostic systems
Long-term Safety and Efficacy of Add-on Cannabidiol in Patients with Lennox-Gastaut Syndrome: Results of a Long- Term Open-Label Extension Trial:CBD long-term safety and efficacy in Lennox-Gastaut syndrome
Dose-Ranging Effect of Adjunctive Oral Cannabidiol vs Placebo on Convulsive Seizure Frequency in Dravet Syndrome A Randomized Clinical Trial
Question Is adjunctive cannabidiol at doses of 10 and 20 mg/kg/d
superior to placebo in reducing convulsive seizure frequency in
patients with Dravet syndrome?
Findings This double-blind clinical trial randomized 199 children
with Dravet syndrome to cannabidiol (10 or 20 mg/kg/d) or
matched placebo for 14 weeks. Convulsive seizure frequency
compared with baseline was reduced by 48.7% in the 10-mg/kg/d
cannabidiol group and 45.7% in the 20-mg/kg/d cannabidiol
group vs 26.9% in the placebo group.
Meaning Both doses of adjunctive cannabidiol were similarly
efficacious in reducing convulsive seizures associated with Dravet
syndrome
WEIGHT LOSS, BLOOD PRESSURE, PULSE AND CIRCADIAN PATTERNS WITH NALTREXONE SUSTAINED-RELEASE/BUPROPION SUSTAINED-RELEASE COMBINATION THERAPY FOR OBESITY
Concurrent Improvement in both Binge Eating and Depressive Symptoms with Naltrexone/Bupropion Therapy in Overweight or Obese Subjects with Major Depressive Disorder in an Open-Label, Uncontrolled Study
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Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 2âExternal Validity and Correlates
Effort-based decision making has strong conceptual links to the motivational disturbances that define a key subdomain of negative symptoms. However, the extent to which effort-based decision-making performance relates to negative symptoms, and other clinical and functionally important variables has yet to be systematically investigated. In 94 clinically stable outpatients with schizophrenia, we examined the external validity of 5 effort-based paradigms, including the Effort Expenditure for Rewards, Balloon Effort, Grip Strength Effort, Deck Choice Effort, and Perceptual Effort tasks. These tasks covered 3 types of effort: physical, cognitive, and perceptual. Correlations between effort related performance and 6 classes of variables were examined, including: (1) negative symptoms, (2) clinically rated motivation and community role functioning, (3) self-reported motivational traits, (4) neurocognition, (5) other psychiatric symptoms and clinical/demographic characteristics, and (6) subjective valuation of monetary rewards. Effort paradigms showed small to medium relationships to clinical ratings of negative symptoms, motivation, and functioning, with the pattern more consistent for some measures than others. They also showed small to medium relations with neurocognitive functioning, but were generally unrelated to other psychiatric symptoms, self-reported traits, antipsychotic medications, side effects, and subjective valuation of money. There were relatively strong interrelationships among the effort measures. In conjunction with findings from a companion psychometric article, all the paradigms warrant further consideration and development, and 2 show the strongest potential for clinical trial use at this juncture
Dose-Ranging Effect of Adjunctive Oral Cannabidiol vs Placebo on Convulsive Seizure Frequency in Dravet Syndrome A Randomized Clinical Trial
Question Is adjunctive cannabidiol at doses of 10 and 20 mg/kg/d
superior to placebo in reducing convulsive seizure frequency in
patients with Dravet syndrome?
Findings This double-blind clinical trial randomized 199 children
with Dravet syndrome to cannabidiol (10 or 20 mg/kg/d) or
matched placebo for 14 weeks. Convulsive seizure frequency
compared with baseline was reduced by 48.7% in the 10-mg/kg/d
cannabidiol group and 45.7% in the 20-mg/kg/d cannabidiol
group vs 26.9% in the placebo group.
Meaning Both doses of adjunctive cannabidiol were similarly
efficacious in reducing convulsive seizures associated with Dravet
syndrome
Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 1âPsychometric Characteristics of 5 Paradigms
Impairments in willingness to exert effort contribute to the motivational deficits characteristic of the negative symptoms of schizophrenia. The current study evaluated the psychometric properties of 5 new or adapted paradigms to determine their suitability for use in clinical trials of schizophrenia. This study included 94 clinically stable participants with schizophrenia and 40 healthy controls. The effort-based decision-making battery was administered twice to the schizophrenia group (baseline, 4-week retest) and once to the control group. The 5 paradigms included 1 that assesses cognitive effort, 1 perceptual effort, and 3 that assess physical effort. Each paradigm was evaluated on (1) patient vs healthy control group differences, (2) test-retest reliability, (3) utility as a repeated measure (ie, practice effects), and (4) tolerability. The 5 paradigms showed varying psychometric strengths and weaknesses. The Effort Expenditure for Rewards Task showed the best reliability and utility as a repeated measure, while the Grip Effort Task had significant patient-control group differences, and superior tolerability and administration duration. The other paradigms showed weaker psychometric characteristics in their current forms. These findings highlight challenges in adapting effort and motivation paradigms for use in clinical trials
Add-Âon cannabidiol in patients with Dravet syndrome: Results of a long-Âterm open-Âlabel extension trial
Objective: Add-on cannabidiol (CBD) reduced seizures associated with Dravet
syndrome (DS) in two randomized, double-blind, placebo-controlled trials:
GWPCARE1 Part B (NCT02091375) and GWPCARE2 (NCT02224703). Patients
whocompletedGWPCARE1 PartA(NCT02091206)orPartB,orGWPCARE2,were
enrolled in a long-term open-label extension trial, GWPCARE5 (NCT02224573).
We present an interim analysis of the safety, efficacy, and patient-reported outcomes from GWPCARE5.
Methods: Patientsreceived a pharmaceutical formulation of highly purified CBD
in oral solution (100 mg/ml), titrated from 2.5 to 20 mg/kg/day over a 2-week period, added to their existing medications. Based on response and tolerance, CBD
could be reduced or increased to 30 mg/kg/day.
Results: Of the 330 patients who completed the original randomized trials, 315
(95%) enrolled in this open-label extension. Median treatment duration was
444 days (range = 18â1535), with a mean modal dose of 22 mg/kg/day; patients
received a median of three concomitant antiseizure medications. Adverse events
(AEs)occurredin97%patients(mild,23%;moderate,50%;severe,25%).Commonly
reported AEs were diarrhea (43%), pyrexia (39%), decreased appetite (31%), and
somnolence (28%). Twenty-eight (9%) patients discontinued due to AEs. Sixtynine (22%) patients had liver transaminase elevations >3 Ă upper limit of normal;
84% were on concomitant valproic acid. In patients from GWPCARE1 Part B and
GWPCARE2, the median reduction from baseline in monthly seizure frequency
assessed in 12-week periods up to Week 156 was 45%â74% for convulsive seizures
and 49%â84% for total seizures. Across all visit windows, âĽ83% patients/caregivers completing a Subject/Caregiver Global Impression of Change scale reported
improvement in overall condition.
Significance: We show that long-term CBD treatment had an acceptable safety
profile and led to sustained, clinically meaningful reductionsin seizure frequency
in patients with treatment-resistant DS