Pharmacological Treatment of Depression in Cancer Patients

1996 ◽  
Vol 169 (4) ◽  
pp. 440-443 ◽  
Author(s):  
Kees Van Heeringen ◽  
Milana Zivkov
Keyword(s):  
Cancer Patients ◽  
Rating Scale ◽  
Controlled Study ◽  
Systematic Research ◽  
Cancer Stage ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Patients With Cancer ◽  
Treatment Of Depression ◽  
Hamilton Rating Scale

BackgroundDepression has a reported mean prevalence of 24% in patients diagnosed with cancer. However, little systematic research on the efficacy of antidepressants in patients with cancer has been performed.MethodThe efficacy and safety of mianserin were studied in 55 depressed women with breast cancer (stage I or II and without known metastases), in a randomised, double-blind, six-week, placebo-controlled study.ResultsStatistically significant differences in the decrease in score from baseline on the Hamilton Rating Scale for Depression and the number of responders, favouring mianserin, were present after 28 and 42 days of treatment Significantly more placebo-treated patients prematurely terminated the study due to lack of efficacy while the safety profile of mianserin was similar to that of placebo.ConclusionsTreatment with mianserin resulted in a significant improvement in depressive symptoms in cancer patients, and was well tolerated.

scholarly journals 111 Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (P301) Assessing Efficacy and Safety of Extended-Release Viloxazine in Children with ADHD

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 272-272 ◽  
Author(s):  
Azmi Nasser ◽  
Joseph T. Hull ◽  
Fatima A. Chowdhry ◽  
Toyin Adewole ◽  
Tesfaye Liranso ◽  
...  
Keyword(s):  
Clinical Global Impression ◽  
Extended Release ◽  
Rating Scale ◽  
Controlled Study ◽  
Average Score ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Double Blind ◽  
T Score ◽  
Total Average

Abstract:Study Objective:SPN-812 (extended-release viloxazine) is a structurally distinct, bicyclic, Serotonin Norepinephrine Modulating Agent (SNMA) in development as a treatment for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. This Phase 3, randomized, double-blind study (P301) evaluated the efficacy and safety of once-daily SPN-812 at doses of 100 and 200 mg compared to placebo in children ages 6-11yrs with ADHD.Method:Inclusion criteria required subjects have a confirmed Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) ADHD diagnosis, ADHD-Rating Scale-5 (ADHD-RS-5) score ≥28, a Clinical Global Impression-Severity score ≥4, and be free of ADHD medication ≥1 week before randomization. This investigation was conducted at 34 study sites in the United States. Subjects (N=477) were randomized 1:1:1 to placebo:100 mg SPN-812:200 mg SPN-812. The 6-week treatment period included up to 1 week of titration and 5 weeks of maintenance (intent-to-treat population: N=460; placebo=155, 100 mg=147, 200 mg=158). The primary efficacy endpoint was the change from baseline (CFB) at end of study (EOS) in ADHD-RS-5 total score. Key secondary endpoints included Clinical Global Impression-Improvement (CGI-I) scores at EOS, and CFB at EOS in Conners 3-Parent Short Form (Conners 3-PS) Composite T-score and in Weiss Functional Impairment Rating Scale-Parent Version (WFIRS-P) total average score. Safety assessments included adverse events (AEs), laboratory tests, vital signs, physical exams, electrocardiograms, and the Columbia-Suicide Severity Rating Scale.Results:Compared to placebo, a significantly greater improvement in ADHD-RS-5 total score was observed in the 100 mg and 200 mg SPN-812 treatment groups beginning at week 1 (p=0.0004, p=0.0244; respectively) through EOS (p=0.0004, p<0.0001; respectively). Significant improvement at EOS for both 100 mg and 200 mg SPN-812 compared to placebo was also observed in CGI-I score (p=0.0020, p<0.0001; respectively), Connors 3-PS Composite T-score (p=0.0003, p=0.0002; respectively), and in WFIRS-P total average score (p=0.0019, p=0.0002, respectively). The most common (≥5%) treatment-related AEs reported were somnolence, decreased appetite, and headache.Conclusions:In this study, SPN-812 at 100 mg and 200 mg doses met the primary and secondary objectives with statistical significance. AE-related dropouts were ≤5%, indicating SPN-812 treatment was well tolerated.This study is an encore of a poster presentation at the 2019 Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP).Funding Acknowledgements:This research was funded by Supernus Pharmaceuticals, Inc., Rockville, MD.

scholarly journals 112 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (P302): Efficacy and Safety of Extended-Release Viloxazine in Adolescents with ADHD

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 272-273 ◽  
Author(s):  
Azmi Nasser ◽  
Joseph T. Hull ◽  
Fatima A. Chowdhry ◽  
Toyin Adewole ◽  
Tesfaye Liranso ◽  
...  
Keyword(s):  
Clinical Global Impression ◽  
Extended Release ◽  
Rating Scale ◽  
Controlled Study ◽  
Average Score ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Double Blind ◽  
T Score ◽  
Total Average

Abstract:Study Objective:SPN-812 (extended-release viloxazine) is a structurally distinct, bicyclic, Serotonin Norepinephrine Modulating Agent (SNMA) in development as a treatment for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. This Phase 3, randomized, double-blind study (P302) evaluated the efficacy and safety of once-daily SPN-812 at doses of 200 and 400 mg compared to placebo in adolescents ages 12-17yrs with ADHD.Method:Inclusion criteria required subjects have a confirmed Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) ADHD diagnosis, ADHD-Rating Scale-5 (ADHD-RS-5) score ≥28, Clinical Global Impression-Severity score ≥4, and be free of ADHD medication ≥1 week before randomization. This investigation was conducted at 34 study sites in the United States. Subjects (N=310) were randomized 1:1:1 to placebo:200 mg SPN-812:400 mg SPN-812. The treatment period included up to 1 week of titration and 5 weeks of maintenance (intent-to-treat population: N=301; placebo=104, 200 mg=94, 400 mg=103). The primary efficacy endpoint was change from baseline (CFB) at end of study (EOS) in ADHD-RS-5 total score. Key secondary endpoints included Clinical Global Impression-Improvement (CGI-I) score at EOS, and CFB at EOS in Conners 3-Parent Short Form (Conners 3-PS) Composite T-score and Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P) total average score. Safety assessments included adverse events (AEs), laboratory tests, vital signs, physical exams, electrocardiograms, and the Columbia-Suicide Severity Rating Scale.Results:Compared to placebo, a significantly greater improvement in ADHD-RS-5 total score was observed in the 200 mg and 400 mg SPN-812 treatment group at EOS (p=0.0232, p=0.0091; respectively). Significant improvement in CGI-I score at EOS for both 200 mg and 400 mg SPN-812 compared to placebo was also observed (p=0.0042, p=0.0003; respectively). No significant change was observed at either dose compared to placebo in the Conners 3-PS Composite T-score (p=0.6854, p=0.0518; respectively), or the WFIRS-P total average score (p=0.2062, p=0.0519; respectively). The most common (≥5%) treatment-related AEs were somnolence, decreased appetite, fatigue, headache, and nausea.Conclusions:In this study, SPN-812 met the primary objective for both the 200 and 400 mg doses, and a key secondary objective (CGI-I) for both the 200 and 400 mg doses. AE-related dropouts were ≤5%, indicating SPN-812 treatment was well tolerated.This study is an encore of a poster presentation at the 2019 Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP).Funding Acknowledgements:This research was funded by Supernus Pharmaceuticals, Inc., Rockville, MD.

A Double-Blind, Placebo-Controlled Study of Fluoxetine in Depressed Patients With Alzheimer's Disease

2001 ◽  
Vol 13 (2) ◽  
pp. 233-240 ◽  
Author(s):  
Gustavo M. Petracca ◽  
Eran Chemerinski ◽  
Sergio E. Starkstein
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Rating Scale ◽  
Functional Independence ◽  
Controlled Study ◽  
Consecutive Series ◽  
Hamilton Depression Scale ◽  
Double Blind ◽  
Treatment Of Depression ◽  
Efficacy Measures

Objective: To examine the efficacy of fluoxetine in the treatment of depression in patients with probable Alzheimer's disease (AD). Methods: This double-blind, parallel-design study included a consecutive series of 41 AD subjects meeting DSM-IV criteria for major or minor depression who were randomized to receive fluoxetine (up to 40 mg/day) or identical-appearing placebo. All patients received biweekly evaluations consisting of the Hamilton Depression Scale (HAM-D) and the Clinical Global Impression as primary efficacy measures, and the Mini-Mental State Exam, Hamilton Rating Scale for Anxiety, and the Functional Independence Measure as secondary efficacy measures. Results: Complete remission of depression was found in 47% of subjects treated with fluoxetine and in 33% of subjects treated with placebo. Both the fluoxetine and the placebo groups showed a significant decline in HAM-D scores over time, but the magnitude of mood improvement was similar for both groups. Fluoxetine was well tolerated, and most side effects were mild. Conclusion: Fluoxetine treatment for depression in AD did not differ significantly from treatment with placebo. Our study also confirms the presence of a placebo effect in the treatment of depression in AD.

A Comparative Double-Blind Trial of the New Antidepressant Caroxazone and Amitriptyline

1978 ◽  
Vol 6 (5) ◽  
pp. 388-394 ◽  
Author(s):  
S Cecchini ◽  
P Petri ◽  
R Ardito ◽  
S R Bareggi ◽  
A Torriti
Keyword(s):  
Clinical Trials ◽  
Rating Scale ◽  
Pharmacological Properties ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial ◽  
End Of Treatment ◽  
Treatment Of Depression ◽  
Symptom Scores ◽  
Hamilton Rating Scale

On the grounds of pharmacological properties and preliminary clinical trials the efficacy of the new antidepressant caroxazone was compared to amitriptyline in the management of depression. Forty patients mostly suffering from a neurotic or anxious-neurotic depression were admitted to a double-blind trial. All patients completed the study. The Hamilton Rating Scale for Depression was used for the clinical assessment at the beginning, during and at the end of treatment. The trial lasted three weeks. A significant improvement was seen for both drugs after seven days on most symptom scores and on total symptom score. No significant differences were found either at seven days or at the end of treatment between the two drugs. There were no significant differences in the incidence and severity of side-effects. In conclusion, caroxazone appears as an effective and well tolerated drug in the treatment of depression.

scholarly journals Randomized, double-blind, placebo-controlled study of methylphenidate for the treatment of depression in SSRI-treated cancer patients receiving palliative care

2016 ◽  
Vol 26 (11) ◽  
pp. 1763-1769 ◽  
Author(s):  
Donald R. Sullivan ◽  
Solange Mongoue-Tchokote ◽  
Motomi Mori ◽  
Elizabeth Goy ◽  
Linda Ganzini
Keyword(s):  
Palliative Care ◽  
Cancer Patients ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Treatment Of Depression

Extended Release Quetiapine Fumarate Monotherapy for Major Depressive Disorder: Results of a Double-Blind, Randomized, Placebo-Controlled Study

CNS Spectrums ◽  
2009 ◽  
Vol 14 (6) ◽  
pp. 299-313 ◽  
Author(s):  
Richard Weisler ◽  
J. Mark Joyce ◽  
Lora McGill ◽  
Arthur Lazarus ◽  
Johan Szamosi ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Extended Release ◽  
Rating Scale ◽  
Controlled Study ◽  
Major Depressive ◽  
Double Blind ◽  
Quetiapine Fumarate ◽  
Quetiapine Xr ◽  
Hamilton Rating Scale

AbstractIntroduction: Once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy was evaluated in major depressive disorder (MDD).Method: This was an 8-week (6-week randomized-phase; 2-week drug-discontinuation/tapering phase), double-blind, parallel-group, placebo-controlled study. The primary outcome measure was Montgomery-Åsberg Depression Rating Scale (MADRS) total score randomization-to-Week 6 change. Other assessments included the Hamilton Rating Scale for Depression, the Hamilton Rating Scale for Anxiety, and adverse events (AEs).Results: 723 patients were randomized: 182, 178, 179, and 184 to quetiapine XR 50, 150, 300 mg/day, and placebo, respectively. At Week 6, significant reductions occurred in MADRS score with quetiapine XR 50 mg/day (−13.56; P<.05), 150 mg/day (−14.50; P<.01) and 300 mg/day (−14.18; P<.01) versus placebo (−11.07); at Day 4, reductions for quetiapine XR (titrated to 50 or 150 mg/day according to dose group) versus placebo (−2.9) were: −4.7 (P<.01), −5.2 (P<.001), and −5.1 (P<.001), respectively. At endpoint, MADRS response (≥50% reduction in score) was 42.7% (P<.01), 51.2% (P<.001), and 44.9% (P≤.001) for quetiapine XR 50, 150, and 300 mg/day, respectively; 30.3% for placebo. Overall, quetiapine XR 150 mg/day provided consistently more positive secondary efficacy results than 50 mg/day and 300 mg/day versus placebo. The most common AEs in quetiapine XR-treated patients were dry mouth, sedation, somnolence, headache, and dizziness.Conclusion: In patients with MDD, quetiapine XR monotherapy (50/150/300 mg/day) is effective in reducing depressive symptoms, with improvement from Day 4 onwards. Safety and tolerability were consistent with the known profile of quetiapine.

scholarly journals Randomised, double-blind, placebo-controlled study of olanzapine in patients with bipolar I depression

2012 ◽  
Vol 201 (5) ◽  
pp. 376-382 ◽  
Author(s):  
Mauricio Tohen ◽  
David P. McDonnell ◽  
Michael Case ◽  
Shigenobu Kanba ◽  
Kyooseob Ha ◽  
...  
Keyword(s):  
Atypical Antipsychotics ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Controlled Study ◽  
Young Mania ◽  
Double Blind ◽  
End Point ◽  
Hamilton Rating Scale ◽  
Rate Of Response

BackgroundAtypical antipsychotics are widely used in bipolar mania. However, the efficacy of atypical antipsychotics in bipolar depression has not been comprehensively explored.AimsTo evaluate olanzapine monotherapy in patients with bipolar depression.MethodPatients with bipolar depression received olanzapine (5–20mg/day, n = 343) or placebo (n = l71) for 6 weeks. The primary outcome was change from baseline to end-point in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Secondary outcomes included: Clinical Global impression - Bipolar Version (CGI-BP) scale, 17-item Hamilton Rating Scale for Depression (HRSD-17) and Young Mania Rating Scale (YMRS) scores, and the rate of response (≥50% reduction in MADRS at end-point), recovery (MADRS ≤12 for ≥4 weeks plus treatment completion) and remission (MADRS ≤8). The trial was registered with ClinicalTrials.gov (NCT00510146).ResultsOlanzapine demonstrated: significantly greater (P<0.04) improvements on MADRS (least-squares mean change -13.82 v. -11.67), HRSD-17 and YMRS total scores and all CGI-BP subscale scores v. placebo; significantly (P≤0.05) more response and remission, but not recovery; significantly (P<0.01) greater mean increases in weight, fasting cholesterol and triglycerides; and significantly more (P<0.001) patients gained ≥7% body weight.ConclusionsOlanzapine monotherapy appears to be efficacious in bipolar depression. Additional long-term studies are warranted to confirm these results. Safety findings were consistent with the known safety profile of olanzapine.

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