Efficacy of olanzapine combined with valproate or lithium in the treatment of dysphoric mania

BackgroundFew controlled studies examine the treatment of depressive features in mania.AimsTo evaluate the efficacy of olanzapine, in combination with lithium or valproate, for treating depressive symptoms associated with mania.MethodSecondary analysis of a 6-week, double-blind, randomised study of olanzapine (5–20 mg/day) or placebo combined with ongoing valproate or lithium open treatment for 344 patients in mixed or manic episodes. This analysis focused on a dysphoric subgroup with baseline Hamilton Rating Scale for Depression (HRSD) total scores of 20 or over contrasted with non-dysphoric patients.ResultsIn the dysphoric subgroup (n=85) mean HRSD total score improvement was significantly greater in olanzapine co-therapy patients than in those receiving placebo plus lithium or valproate (P<0.001). Substantial contributors to this superiority included the HRSD Maier sub-scale (P=0.013) and the suicide item (P=0.001). Total Young Mania Rating Scale improvement was also superior with olanzapine co-therapy.ConclusionsIn patients with acute dysphoric mania, addition of olanzapine to ongoing lithium or valproate monotherapy significantly improved depressive symptom, mania and suicidality ratings.

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

The British Journal of Psychiatry ◽

10.1192/bjp.bp.112.108357 ◽

2012 ◽

Vol 201 (5) ◽

pp. 376-382 ◽

Cited By ~ 62

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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An intervention for depressive symptoms using a commercial game in a mental health impatient setting. (Preprint)

10.2196/preprints.13890 ◽

2019 ◽

Author(s):

Pablo Rodrigo Guzman Cortez ◽

Matias Marzocchi ◽

Neus Freixa Fontanals ◽

Mercedes Balcells-Olivero

Keyword(s):

Mental Health ◽

Depressive Symptoms ◽

Health Outcomes ◽

Serious Games ◽

Rating Scale ◽

Depressive Symptomatology ◽

Pilot Test ◽

Potential Health ◽

Depressive Episodes ◽

Hamilton Rating Scale

BACKGROUND Computerized mental health interventions have shown evidence of their potential benefit for mental health outcomes in young users. All of the studied interventions available in the review and scientific literature can be classified as "serious games". Serious games are computerized interventions designed from the start with the objective of improving specific desired health outcomes. Moreover, there are reports of users experiencing subjective benefits in mental health after playing specific commercial games. These were games not intentionally made with a therapeutic objective in the design process. An example is the videogame "Journey", first released for the Playstation 3 console in 2012 which won "Game of the Year" in the 2013 D.I.C.E awards. The creator of the game describes the game as a short, 2-3-hour narrative experience in which the player goes through the "Hero's Journey" following a classic 3-part structure. There were more than 100 testimonials from players describing how the game helped them cope with psychological or personal issues. Some of them explicitly described recovering from depressive episodes through playing the game. OBJECTIVE To conduct a pilot test of the efficacy of the videogame Journey in reducing depressive symptoms in an acute impatient setting METHODS Depressive symptomatology was measured before and after the intervention using the Hamilton Rating Scale for Depression (HRSD) The intervention was conducted in an isolated room using a Playstation 3 console with the videogame "Journey" developed by Thatgamecompany. No internet access was allowed. The game was played over the course of 4 30-45 min sessions in a two week period. RESULTS The initial score in the Hamilton Rating Scale for Depression (HRSD) was 30, indicating a very severe depression. After the intervention the HRSD score was 10, showing a mild depression. CONCLUSIONS The Videogame Journey, a commercial game first available for the Playstation 3 console in 2012, was not created as a serious game with potential health benefits. Our pilot test is the first case report of a commercial game showing a potential effect in reducing depressive symptoms, which is consistent with the previous informal reports of users online.

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Double-blind clonazepam vs placebo in panic disorder treatment

Arquivos de Neuro-Psiquiatria ◽

10.1590/s0004-282x2000000600008 ◽

2000 ◽

Vol 58 (4) ◽

pp. 1025-1029 ◽

Cited By ~ 21

Author(s):

ALEXANDRE MARTINS VALENÇA ◽

ANTONIO EGIDIO NARDI ◽

ISABELLA NASCIMENTO ◽

MARCO A. MEZZASALMA ◽

FABIANA L. LOPES ◽

...

Keyword(s):

Panic Disorder ◽

Rating Scale ◽

Panic Attacks ◽

Fixed Dose ◽

Fisher Exact Test ◽

Double Blind ◽

Exact Test ◽

Dsm Iv ◽

Disorder Treatment ◽

Hamilton Rating Scale

OBJECTIVE: To assess the effectiveness of clonazepam, in a fixed dose (2 mg/day), compared with placebo in the treatment of panic disorder patients. METHOD: 24 panic disorder patients with agoraphobia were randomly selected. The diagnosis was obtained using the structured clinical interview for DSM-IV . All twenty-four subjects were randomly assigned to either treatment with clonazepam (2 mg/day) or placebo, during 6 weeks. Efficacy assessments included: change from baseline in the number of panic attacks; CGI scores for panic disorder; Hamilton rating scale for anxiety; and panic associated symptoms scale. RESULTS: At the therapeutic endpoint, only one of 9 placebo patients (11.1%) were free of panic attacks, compared with 8 of 13 (61.5%) clonazepam patients (Fisher exact test; p=0,031). CONCLUSION: the results provide evidence for the efficacy of clonazepam in panic disorder patients.

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Recovery and its correlates among patients with bipolar disorder: A study from a tertiary care centre in North India

International Journal of Social Psychiatry ◽

10.1177/0020764016676214 ◽

2016 ◽

Vol 62 (8) ◽

pp. 726-736 ◽

Cited By ~ 5

Author(s):

Sandeep Grover ◽

Nandita Hazari ◽

Jitender Aneja ◽

Subho Chakrabarti ◽

Sunil Sharma ◽

...

Keyword(s):

Bipolar Disorder ◽

Mental Illness ◽

Depressive Symptoms ◽

Rating Scale ◽

Tertiary Care ◽

North India ◽

Personal Recovery ◽

Tertiary Care Centre ◽

Young Mania ◽

Level Of Functioning

Background and Aim: The goal of treatment in mental illness has evolved from a symptom-based approach to a personal recovery–based approach. The aim of this study was to evaluate the predictors of personal recovery among patients with bipolar disorder. Methodology: A total of 185 patients with bipolar disorder, currently in remission, were evaluated on Recovery Assessment Scale (RAS), Internalized Stigma of Mental Illness Scale (ISMIS), Brief Religious coping scale (RCOPE), Duke University Religiosity Index (DUREL), Religiousness Measures Scale, Hamilton depression rating scale (HDRS), Young Mania rating scale (YMRS) and Global Assessment of Functioning (GAF) scale. Results: The mean age of the sample was 40.5 (standard deviation (SD), 11.26) years. Majority of the participants were male, married, working, Hindu by religion and belonged to extended/joint families of urban background. In the regression analysis, RAS scores were predicted significantly by discrimination experience, stereotype endorsement and alienation domains of ISMIS, level of functioning as assessed by GAF, residual depressive symptoms as assessed by HDRS and occupational status. The level of variance explained for total RAS score and various RAS domains ranged from 36.2% to 46.9%. Conclusion: This study suggests that personal recovery among patients with bipolar disorder is affected by stigma, level of functioning, residual depressive symptoms and employment status of patients with bipolar disorder.

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Living With Bipolar Disorder in the Time of Covid-19: Biorhythms During the Severe Lockdown in Cagliari, Italy, and the Moderate Lockdown in Tunis, Tunisia

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.634765 ◽

2021 ◽

Vol 12 ◽

Author(s):

Mauro Giovanni Carta ◽

Uta Ouali ◽

Alessandra Perra ◽

Azza Ben Cheikh Ahmed ◽

Laura Boe ◽

...

Keyword(s):

Bipolar Disorder ◽

Depressive Symptoms ◽

Rating Scale ◽

Biological Rhythms ◽

Short Term ◽

Female Age ◽

Future Studies ◽

Restrictive Measures ◽

Depressive Episodes ◽

Hamilton Rating Scale

Background: Restrictions during Covid-19 pandemic lockdown, in which rhythms of life have been compromised, can influence the course of bipolar disorder (BD). This study follows patients with bipolar disorder living in two geographically close cities (Cagliari and Tunis), but with different lockdown conditions: less severe in Tunis.Methods: Two cohorts were evaluated during lockdown (April 2020, t0) and 2 months later with lockdown lifted for a month (t1). Individuals were: over 18 years old without gender exclusion, BD I or II, in care for at least 1 year, received a clinical interview in the month before the start of the lockdown, stable clinically before the lockdown. The assessment was conducted by telephone by a psychiatrist or psychologist with good knowledge of patients. Diagnoses were made according to DSM-5 criteria. Depressive symptoms were collected through the Hamilton Rating Scale for Depression; cut-off 14 indicative of depressive episode. Circadian rhythms were measured using the BRIAN scale.Results: Forty individuals in Cagliari (70%female, age 48.57 ± 11.64) and 30 in Tunis (53.3% Female, age 41.8 ± 13.22) were recruited. In Cagliari at t0 45% had depressive episodes against none in Tunis, a similar difference appeared at t1. At t0 and t1 the Cagliari sample had more dysfunctional scores in the overall BRIAN scale and in the areas of sleep, activities and social rhythms; no differences were found in nutrition, both samples had predominantly nocturnal rhythm. In Cagliari at t0 and t1, the depressive sub-group showed more dysfunctional scores in the BRIAN areas sleep, activity, and nutrition. However, the differences in biological rhythms resulted, through ANCOVA analysis, independent of the co-presence of depressive symptoms.Discussion: A rigid lockdown could expose people with BD to depressive relapse through dysregulation of biological rhythms. The return to more functional rhythms did not appear 1 month after lockdown. The rekindling of the pandemic and the restoration of new restrictive measures will prevent, at least in the short term, the beneficial effect of a return to normality of the two cohorts.This was a limited exploratory study; future studies with larger samples and longer observational time are needed to verify the hypothesis.

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Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽

10.1017/s1092852900023075 ◽

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.

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

The British Journal of Psychiatry ◽

10.1192/bjp.188.1.46 ◽

2006 ◽

Vol 188 (1) ◽

pp. 46-50 ◽

Cited By ~ 191

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.

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Comparison of efficacy between risperidone and aripiprazole in combination with sodium valproate in patients with acute manic or mixed episodes

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.1390 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S749-S749

Author(s):

N. Amanat ◽

A. Nazeri Astane ◽

B. Dieji ◽

O. Rezaie ◽

A. Biglarian

Keyword(s):

Weight Gain ◽

Sodium Valproate ◽

Rating Scale ◽

Analysis Of Covariance ◽

Young Mania ◽

Double Blind ◽

Measurement Evaluation ◽

Significant Difference ◽

Competing Interest ◽

Bipolar Patients

Today, despite of the improvement in the psychological therapeutic approach, mania still remains as a challenging problem for health system. The aim of this study is comparison efficacy of risperidone and aripiprazole in combination with sodium valproate in bipolar patients with acute manic or mixed episodes who hospitalized in Razi psychiatric hospital in Tehran. This study was conducted as a double blind randomized clinical trial in two groups of bipolar disorder patients with manic or mixed episodes (18–65 age). Patients randomly set in two groups who received valproate with aripiprazole or risperidone. Clinical response was assessed with young mania rating scale (YMRS) and weight gain at 3 and 6 weeks. Data was analyzed with Chi2 test, paired t-test and analysis of covariance and repeated measurement. Evaluation of treatment response after 3 and 6 weeks (50% reduction in Young's scale) in both groups did not show any significant difference between the two therapeutic combinations. The combination of sodium valproate and risperidone showed higher weight gain in comparison with the combination of valproate and aripiprazole at the end of week 6 (P < 0.001). The mentioned combination in bipolar I disorder with manic or mixed episode has similar therapeutic effect, so that both of them are effective and usable. There was no difference in their efficacy, and both treatments can be used. Due to the less weight gain, the combination of valproate and aripiprazole in patients who prone to weight gain, this approach is recommended as more safe and effective therapy.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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Empirical evidence for definitions of episode, remission, recovery, relapse and recurrence in depression: a systematic review

Epidemiology and Psychiatric Sciences ◽

10.1017/s2045796018000227 ◽

2018 ◽

Vol 28 (5) ◽

pp. 544-562 ◽

Cited By ~ 17

Author(s):

P. L. de Zwart ◽

B. F. Jeronimus ◽

P. de Jonge

Keyword(s):

Depressive Symptoms ◽

Depressive Episode ◽

Rating Scale ◽

Driving Forces ◽

Evidence Based ◽

Limited Data ◽

Major Depressive ◽

The Past ◽

Duration Threshold ◽

Hamilton Rating Scale

Aims.For the past quarter of a century, Frank et al.’s (1991) consensus-based definitions of major depressive disorder (MDD) episode, remission, recovery, relapse and recurrence have been the paramount driving forces for consistency in MDD research as well as in clinical practice. This study aims to review the evidence for the empirical validation of Frank et al.’s proposed concept definitions and to discuss evidence-based modifications.Methods.A literature search of Web of Science and PubMed from 1/1/1991 to 08/30/2017 identified all publications which referenced Frank et al.’s request for definition validation. Publications with data relevant for validation were included and checked for referencing other studies providing such data.Results.A total of 56 studies involving 39 315 subjects were included, mainly presenting data to validate the severity and duration thresholds for defining remission and recovery. Most studies indicated that the severity threshold for defining remission should decrease. Additionally, specific duration thresholds to separate remission from recovery did not add any predictive value to the notion that increased remission duration alleviates the risk of reoccurrence of depressive symptoms. Only limited data were available to validate the severity and duration criteria for defining a depressive episode.Conclusions.Remission can best be defined as a less symptomatic state than previously assumed (Hamilton Rating Scale for Depression, 17-item version (HAMD-17) ⩽4 instead of ⩽7), without applying a duration criterion. Duration thresholds to separate remission from recovery are not meaningful. The minimal duration of depressive symptoms to define a depressive episode should be longer than 2 weeks, although further studies are required to recommend an exact duration threshold. These results are relevant for researchers and clinicians aiming to use evidence-based depression outcomes.

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