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.

scholarly journals Efficacy of ethyl-eicosapentaenoic acid in bipolar depression: Randomised double-blind placebo-controlled study

2006 ◽  
Vol 188 (1) ◽  
pp. 46-50 ◽  
Author(s):  
Sophia Frangou ◽  
Michael Lewis ◽  
Paul McCrone
Keyword(s):  
Eicosapentaenoic Acid ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Unipolar Depression ◽  
Adjunctive Treatment ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Double Blind Study ◽  
Young Mania ◽  
Double Blind

BackgroundEpidemiological and clinical studies suggest that increased intake of eicosapentaenoic acid (EPA) alleviates unipolar depression.AimsTo examine the efficacy of EPA in treating depression in bipolar disorder.MethodIn a 12-week, double-blind study individuals with bipolar depression were randomly assigned to adjunctive treatment with placebo (n=26) or with 1g/day (n=24) or 2 g/day (n=25) of ethyl-EPA. Primary efficacy was assessed by the Hamilton Rating Scale for Depression (HRSD), with changes in the Young Mania Rating Scale and Clinical Global Impression Scale (CGI) as secondary outcome measures.ResultsThere was no apparent benefit of 2g over 1g ethyl-EPA daily. Significant improvement was noted with ethyl-EPA treatment compared with placebo in the HRSD (P=0.04) and the CGI (P=0.004) scores. Both doses were well tolerated.ConclusionsAdjunctive ethyl-EPA is an effective and well-tolerated intervention in bipolar depression.

Antidepressant Effects of Atypical Antipsychotics

CNS Spectrums ◽  
2003 ◽  
Vol 8 (S12) ◽  
pp. 6-8
Author(s):  
Roy H. Perlis
Keyword(s):  
Atypical Antipsychotics ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Case Series ◽  
Depression Score ◽  
Antidepressant Effects ◽  
Open Treatment ◽  
Depressive Episodes ◽  
Hamilton Rating Scale

Studies have shown that there is some efficacy for a number of agents, most notably lithium, in treating bipolar depression. However, the studies also highlight the unfortunate reality that many patients fail to respond adequately to first-line therapies and that there is a need to identify additional options for patients and clinicians. The atypical antipsychotics clozapine, olanzapine, quetiapine, risperidone, ziprasidone, and aripiprazole, have been the focus of increased interest in the treatment of bipolar depression.The use of antipsychotics in the treatment of depressive episodes is not a particularly novel idea. In 1982, Robertson and Trimble reviewed 34 studies examining the use of typical antipsychotics to augment an antidepressant and noticed modest but generally consistent benefits. More widespread use of these agents in the management of depression has been limited, however, because of concerns about the long-term risk of tardive dyskinesia and the induction of extrapyramidal symptoms that often mimic depressive symptoms.Clozapine, the first of the atypicals, was applied initially in the treatment of schizophrenia and schizoaffective disorder, where antidepressant effects were noted during open treatment. Subsequent case series described some benefit in dysphoric manias in bipolar disorder as well.Much of the inditect evidence for antidepressant effects of the atypicals came from studies in major depressive disorder (MDD). For example, a series of eight patients with MDD who failed treatment with a selective serotonin reuptake inhibitor (SSRI) achieved marked and rapid response when risperidone was added to the SSRI. All patients remitted within 1 week; Hamilton Rating Scale for Depression score in these patients declined from a mean of 20.5 to a mean of 2.4 (Slide 11). A subsequent series of 30 patients yielded similar results.

scholarly journals Treatment of bipolar depression with supraphysiologic doses of levothyroxine: a randomized, placebo-controlled study of comorbid anxiety symptoms

2019 ◽  
Vol 7 (1) ◽  
Author(s):  
Maximilian Pilhatsch ◽  
Thomas J Stamm ◽  
Petra Stahl ◽  
Ute Lewitzka ◽  
Anne Berghöfer ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Phenotypic Expression ◽  
Anxiety Symptoms ◽  
Controlled Study ◽  
Double Blind ◽  
Comorbid Anxiety ◽  
Depressed Patients ◽  
Depressive Episodes

Abstract Background Symptoms of anxiety co-occur in a variety of disorders including in depressive episodes of bipolar disorder and in patients with thyrotoxicosis. Treatment of refractory bipolar disorder with supraphysiologic doses of levothyroxine (L-T4) has been shown to improve the phenotypic expression of the disorder and is associated with an increase of circulating thyroid hormones. However, it might be associated with somatic and mental adverse effects. Here we report the investigation of the influence of treatment with supraphysiologic doses of L-T4 on symptoms of anxiety in patients with refractory bipolar depression. Methods Post-hoc analysis from a 6-week, multi-center, randomized, double-blind, placebo-controlled study of the effects of supraphysiologic L-T4 treatment on anxiety symptoms in bipolar depression. Anxiety symptoms were measured weekly with the Hamilton anxiety/somatization factor (HASF) score of the Hamilton Depression Rating Scale (HAMD) and the State- and Trait Anxiety Inventory (STAI). Results Treatment of both groups was associated with a significant reduction in anxiety symptoms (p < 0.001) with no statistical difference between groups (LT-4: from 5.9 (SD = 2.0) at baseline to 3.7 (SD = 2.4) at study end; placebo: from 6.1 (SD = 2.4) at baseline to 4.4 (SD = 2.8) at study end; p = 0.717). Severity of anxiety at baseline did not show a statistically significant correlation to the antidepressive effect of treatment with supraphysiologic doses of L-T4 (p = 0.811). Gender did not show an influence on the reduction of anxiety symptoms (females: from 5.6 (SD = 1.7) at baseline to 3.5 (SD = 2.4) at study end; males: from 6.1 (SD = 2.3) at baseline to 4.0 (SD = 2.4) at study end; p = 0.877). Conclusions This study failed to detect a difference in change of anxiety between bipolar depressed patients treated with supraphysiologic doses of L-T4 or placebo. Comorbid anxiety symptoms should not be considered a limitation for the administration of supraphysiologic doses of L-T4 refractory bipolar depressed patients. Trial registration ClinicalTrials, ClinicalTrials.gov identifier: NCT01528839. Registered 2 June 2012—Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT01528839

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (6) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (S1) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

The association between insight and symptoms in bipolar inpatients: An Italian prospective study

2011 ◽  
Vol 27 (8) ◽  
pp. 619-624 ◽  
Author(s):  
C. Bressi ◽  
M. Porcellana ◽  
P.M. Marinaccio ◽  
E.P. Nocito ◽  
M. Ciabatti ◽  
...  
Keyword(s):  
Regression Models ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Demographic Characteristics ◽  
Social Consequences ◽  
Young Mania ◽  
Hamilton Rating Scale ◽  
Insight Into ◽  
Multidimensional Concept

AbstractObjectiveTo evaluate potential differences in insight among bipolar manic, mixed and bipolar depressed inpatients and assess the role of clinical and demographic characteristics as possible predictors.MethodOne hundred and twenty consecutive inpatients divided into three diagnostic groups were studied on admission (T0), at discharge (T1) and at 18weeks after hospitalization (T2). The Young Mania Rating Scale (YMRS), the Hamilton Rating Scale for Depression (HAMD) and the Scale to Assess Unawareness of Mental Disorder (SUMD) were used.ResultsPatients with mixed mania showed highest scores on the SUMD than patients with mania or bipolar depression. It was found a significant relationship between improvements in mania and in the insight. The level of insight at baseline was the only predictor of awareness in social consequences, moreover clinical and demographic characteristics were predictors of insight into mental illness. For what concerns insight about therapy benefits it was influenced by level of mania at baseline.ConclusionThe three general dimensions of insight revealed significant differences among the three groups. Regression models suggest that insight is a multidimensional concept in which some aspects are state-related, associated with psychopathology, whereas others are trait-like qualities, not directly associated with symptoms and predicted only by level at baseline.

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.

Agomelatine versus escitalopram in major depressive disorders : a randomized double-blind, long term study focusing on sleep satisfaction and emotional blunting

2011 ◽  
Vol 26 (S2) ◽  
pp. 619-619 ◽  
Author(s):  
E. Corruble ◽  
C. Bélaidi ◽  
G.M. Goodwin
Keyword(s):  
Depressive Symptoms ◽  
Depressive Disorders ◽  
Rating Scale ◽  
Statistical Significance ◽  
Controlled Study ◽  
Major Depressive ◽  
Double Blind ◽  
Long Term Study ◽  
Long Term Treatment

The novel antidepressant agomelatine is a MT1/MT2 receptor agonist and a 5HT2c receptor antagonist, whose efficacy is demonstrated in Major Depressive Disorder (MDD) (1). In an international 24-week double-blind randomized controlled study, the effects of agomelatine 25–50 mg/d (n = 164) were compared to those of escitalopram 10-20 mg/d (n = 160) on satisfaction about sleep (Visual Analogic Scale), depressive symptoms (Hamilton Depression Rating Scale (HAM-D)) and emotions in a subset of 45 patients having completed the Oxford Depression Questionnaire (2).Both drugs improved depressive symptoms (mean decrease in HAM-D score from baseline: -19.9 with agomelatine and -19.2 with escitalopram; percentage of remitters: 69.6% with agomelatine and 63.1% with escitalopram, LOCF endpoint) and the satisfaction about sleep. Interestingly, the wellness feeling on waking was more improved with agomelatine as compared to escitalopram (p = 0.025), indicating a better alertness on waking with agomelatine than escitalopram.Moreover, emotional blunting was less frequent with agomelatine as compared to escitalopram: 28% on agomelatine vs 60% on escitalopram felt that their emotions lacked intensity with a trend to statistical significance (p = 0.063) and 16% of patients on agomelatine vs 53% on escitalopram felt that things that they cared about before illness did not seem important any more (p = 0.024). Finally, less patients withdrew due to emergent adverse events with agomelatine (4.3%) as compared to escitalopram (10.6%), (p = 0.029). To conclude, this study shows some potential clinical advantages of agomelatine as compared to escitalopram in the long term treatment of MDD.

scholarly journals Risperidone in the treatment of acute mania

2005 ◽  
Vol 187 (3) ◽  
pp. 229-234 ◽  
Author(s):  
Sumant Khanna ◽  
Eduard Vieta ◽  
Benjamin Lyons ◽  
Fred Grossman ◽  
Mariëlle Eerdekens ◽  
...  
Keyword(s):  
Rating Scale ◽  
Acute Mania ◽  
Young Mania ◽  
Double Blind ◽  
Manic Symptoms ◽  
End Point ◽  
Increased Risk ◽  
Rapid Control ◽  
Life Threatening ◽  
Point Total

BackgroundSevere mania is life-threatening, carries an increased risk of suicide and has a serious impact on patients and their families. Efficient and rapid control of episodes of acute mania is needed.AimsTo evaluate the safety and efficacy of risperidone monotherapy for acute mania.MethodIn a 3-week, randomised, double-blind trial, 290 in-patients with bipolar l disorder with current manic or mixed episode and a baseline Young Mania Rating Scale (YMRS) score of 20 or more received flexible doses of risperidone (1–6 mg per day) or placebo.ResultsRisperidone was received by 146 patients and placebo by 144. Their mean baselineYMRS score was 37. 2 (s. e. =0. 5). Significantly greater improvements were observed with risperidone than with placebo at weeks l and 2 and at end-point (total YMRS: P<0. 01). Extrapyramidal symptoms were the most frequently reported adverse events in the risperidone group.ConclusionsIn patients with severe manic symptoms, risperidone produced significant improvements in YMRS scores as early as week 1 and substantial changes at end-point. Treatment was well tolerated.

scholarly journals Cariprazine efficacy in bipolar I depression with and without concurrent manic symptoms: post hoc analysis of 3 randomized, placebo-controlled studies

CNS Spectrums ◽  
2019 ◽  
Vol 25 (4) ◽  
pp. 502-510 ◽  
Author(s):  
Roger S. McIntyre ◽  
Trisha Suppes ◽  
Willie Earley ◽  
Mehul Patel ◽  
Stephen M. Stahl
Keyword(s):  
Least Squares ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Simultaneous Occurrence ◽  
Madrs Total Score ◽  
Young Mania ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Manic Symptoms ◽  
Post Hoc

AbstractObjective.Mixed presentations, defined by simultaneous occurrence of depressive and manic symptoms, are difficult to treat. Antidepressants, although commonly used, have weak evidence of efficacy and may increase risk of mood destabilization. The aim of this pooled post hoc analysis was to evaluate the efficacy of cariprazine in the treatment of bipolar depression with or without concurrent manic symptoms.Methods.Patients from 3 randomized, double-blind, placebo-controlled studies who met DSM-IV-TR or DSM-5 criteria for bipolar I disorder with a current major depressive episode were identified to have concurrent manic symptoms by baseline Young Mania Rating Scale total score ≥4. Efficacy was assessed in cariprazine 1.5 and 3 mg/day dose groups versus placebo; analyses included the least squares mean change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.Results.Of 1383 patients randomized to treatment, 808 (58.4%) had concurrent manic symptoms. For patients with manic symptoms, mean reduction in MADRS total score from baseline to week 6 was significantly greater for both cariprazine 1.5 and 3 mg/day compared with placebo, with least squares mean differences (LSMDs) versus placebo of −2.5 (p = .0033) and −2.9 (p = .0010), respectively; for patients without manic symptoms, the LSMD was significant for 1.5 mg/day (−3.3; p = .0008), but not for 3 mg/day (−1.9; p = .0562).Conclusion.The results of this post hoc analysis suggest that cariprazine may be an appropriate treatment option for patients with bipolar I depression with or without manic symptoms, with higher doses potentially more effective in patients with manic symptoms.

Sign in / Sign up

Export Citation Format

Share Document