An Open-Label Trial of Aripiprazole Monotherapy in Children and Adolescents with Bipolar Disorder

CNS Spectrums ◽  
2007 ◽  
Vol 12 (9) ◽  
pp. 683-689 ◽  
Author(s):  
Joseph Biederman ◽  
Eric Mick ◽  
Thomas Spencer ◽  
Robert Doyle ◽  
Gagan Joshi ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Rating Scale ◽  
Vital Signs ◽  
Pediatric Bipolar Disorder ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Scale Scores ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

ABSTRACTIntroduction: Aripiprazole is a novel second-generation antipsychotic approved for the treatment of bipolar disorder in adults but there is no systematic data available in pediatric bipolar disorder.Methods: This was an 8-week, open-label, prospective study of aripiprazole 9.4±4.2 mg/day monotherapy to assess the efficacy and tolerability of this compound in treating pediatric bipolar disorder. Assessments included the Young Mania Rating Scale, Clinical Global Impressions-Improvement scale, and Brief Psychiatric Rating Scale. Adverse events were assessed through spontaneous self-reports, vital signs weight monitoring, and laboratory analysis.Results: Fifteen of the 19 bipolar youth (79%) completed the study. Aripiprazole treatment was associated with clinically and statistically significant improvement in mean Young Mania Rating Scale scores (−18.0±6.9, P<.0001). With the important exception of two cases of extrapyramidal symptoms that precipitated dropout, aripiprazole was well tolerated with no statistically significant increase in body weight (1.8±1.7 kg, P=.2).Conclusion: Open-label aripiprazole treatment was beneficial in the treatment of mania in youth with bipolar disorder. Future placebo-controlled, double blind studies are warranted.

scholarly journals Does the efficacy of asenapine in bipolar disorder increase in the presence of comorbidity with a substance use disorder? A naturalistic study

2016 ◽  
Vol 7 (2) ◽  
pp. 67-77 ◽  
Author(s):  
Sergio De Filippis ◽  
Ilaria Cuomo ◽  
Georgios D. Kotzalidis ◽  
Daniela Pucci ◽  
Pietro Zingaretti ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Substance Use ◽  
Substance Use Disorder ◽  
Repeated Measures ◽  
Rating Scale ◽  
Type I ◽  
Open Label ◽  
Young Mania ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

Background: Asenapine is a second-generation antipsychotic approved in Europe for treating moderate-to-severe manic episodes in adults affected by type I bipolar disorder (BD-I). We aimed to compare its efficacy in psychiatric inpatients with BD-I, with or without substance use disorder (SUD). Methods: We administered flexible asenapine doses ranging from 5–20 mg/day to 119 voluntarily hospitalized patients with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) BD-I diagnosis, with or without SUD. Patients were assessed with clinician-rated questionnaires [i.e. Brief Psychiatric Rating Scale (BPRS), Young Mania Rating Scale (YMRS), Hamilton Depression Rating Scale (HDRS), Hamilton Anxiety Rating Scale (HARS), and Global Assessment of Functioning (GAF)]. Assessments were carried out at baseline (T0, prior to treatment), and 3 (T1), 7 (T2), 15 (T3), and 30 days (T4) after starting treatment for all clinical scales and at T0 and T4 for the GAF. Results: Patients improved on all scales ( p < 0.001) across all timepoints, as shown both by paired-sample comparisons and by applying a repeated-measures, generalized linear model (GLM). Patients without comorbid SUD showed greater reductions in BPRS scores at T2 and T3, greater reduction in YMRS scores at T3, and lower HARS scores at all timepoints. HDRS scores did not differ between the two groups at any timepoint. However, the reduction in HARS scores in the comorbid group was stronger than in the BD-I only group, albeit not significantly. Side effects were few and mild-to-moderate. Conclusions: The open-label design and the relatively short observation period may expose to both type I and type II statistical errors (false positive and false negatives). Asenapine showed effectiveness and safety in hospitalized BD-I patients. Its effect was stronger in patients without comorbid SUD.

A preliminary naturalistic study of low-dose ketamine for depression and suicide ideation in the emergency department

2011 ◽  
Vol 26 (S2) ◽  
pp. 1607-1607 ◽  
Author(s):  
G.L. Larkin ◽  
A.L. Beautrais ◽  
R.R. Turelli ◽  
G. Sanacora ◽  
S. Powsner ◽  
...  
Keyword(s):  
Suicide Ideation ◽  
Rating Scale ◽  
Rapid Onset ◽  
Open Label ◽  
Young Mania ◽  
Brief Psychiatric Rating Scale ◽  
Kaplan Meier ◽  
Scale Scores ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

BackgroundRapid-onset antidepressants could have important clinical impact if their benefits extended to ED patients. We examined preliminary feasibility, tolerability and efficacy of single-dose IV ketamine in depressed ED patients with suicide ideation (SI).MethodsFourteen depressed ED patients with SI received a single IV bolus of ketamine (0.2 mg/kg) over 1–2 minutes. Patients were monitored for 4 hours, then re-contacted daily for 10 days. Treatment response and time to remission were evaluated using the Montgomery-Asberg Depression Rating Scale (MADRS) and Kaplan Meier survival analysis, respectively.ResultsBrief Psychiatric Rating Scale and Young Mania Rating Scale scores transiently increased in two subjects, consistent with ketamine's cognitive/behavioral effects in other populations. Mean MADRS scores fell significantly from 40.4 (SEM:1.8) at baseline to 11.5 (2.2) at 240 minutes. Median time to MADRS score ≤10 was 80 minutes (Interquartile Range: 0.67–24 hours). Suicide ideation scores (MADRS item 10) decreased significantly from 3.9 (SEM:0.4) at baseline to 0.6 (SEM:0.2) at 40 minutes post-administration, with improvements sustained over 10 days.ConclusionsThese data provide preliminary, open-label support for the feasibility and efficacy of ketamine as a rapid-onset antidepressant in the ED.

scholarly journals Open-Label Adjunctive Topiramate in the Treatment of Unstable Bipolar Disorder

2005 ◽  
Vol 50 (7) ◽  
pp. 415-422 ◽  
Author(s):  
Roger S McIntyre ◽  
Rosanna Riccardelli ◽  
Carin Binder ◽  
Vivek Kusumakar
Keyword(s):  
Bipolar Disorder ◽  
Adverse Events ◽  
Rating Scale ◽  
Vital Signs ◽  
Mood Stabilizers ◽  
Open Label ◽  
Young Mania ◽  
Satisfaction With Treatment ◽  
The Mean ◽  
Intent To Treat

Objective: To assess open-label adjunctive topiramate in the treatment of outpatients with unstable bipolar disorder (BD). Method: Outpatients with DSM-IV–defined BD (I or II) exhibiting mood instability were enrolled in this 16-week, open-label, multicentre study. Topiramate was added to existing mood stabilizers and other psychotropic treatments. The primary effectiveness measure was the Clinical Global Impression of Severity (CGI-S) scale; other scales included the Young Mania Rating Scale (YMRS) and the Montgomery–Asberg Depression Rating Scale (MADRS). Safety assessments included monitoring adverse events, measuring tremor, monitoring vital signs and weight, and laboratory indices. We also evaluated patient satisfaction with treatment. Results: A total of 109 patients were enrolled. Intent-to-treat analysis showed significant improvement from baseline in the CGI-S, YMRS, and MADRS, starting at Week 2 ( P < 0.001), with further accrual of benefit between Week 2 and Week 16 ( P < 0.001). The mean modal dosage of topiramate during the stable dosing period was 180 mg daily. There was a mean 1.8 kg decrease in patient weight from topiramate initiation to Week 16 ( P < 0.001). Topiramate was well tolerated by most patients; 11% withdrew from the study owing to adverse events. We noted a significant reduction in the mean severity score for preexisting tremor by Week 8 of treatment ( P < 0.005); no notable changes in vital signs were observed. At Week 16, 50% of the patients were “completely satisfied” with topiramate treatment. Conclusions: Adjunctive topiramate treatment can reduce the severity of manic and depressive symptoms, as well as reducing tremor and weight in outpatients with BD I or II.

Single i.v. ketamine augmentation of newly initiated escitalopram for major depression: results from a randomized, placebo-controlled 4-week study

2015 ◽  
Vol 46 (3) ◽  
pp. 623-635 ◽  
Author(s):  
Y.-D. Hu ◽  
Y.-T. Xiang ◽  
J.-X. Fang ◽  
S. Zu ◽  
S. Sha ◽  
...  
Keyword(s):  
Single Dose ◽  
Rating Scale ◽  
Depressive Symptomatology ◽  
Self Report ◽  
Young Mania ◽  
Double Blind ◽  
Brief Psychiatric Rating Scale ◽  
Antidepressant Efficacy ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

BackgroundWhile oral antidepressants reach efficacy after weeks, single-dose intravenous (i.v.) ketamine has rapid, yet time-limited antidepressant effects. We aimed to determine the efficacy and safety of single-dose i.v. ketamine augmentation of escitalopram in major depressive disorder (MDD).MethodThirty outpatients with severe MDD (17-item Hamilton Rating Scale for Depression total score ⩾24) were randomized to 4 weeks double-blind treatment with escitalopram 10 mg/day+single-dose i.v. ketamine (0.5 mg/kg over 40 min) or escitalopram 10 mg/day + placebo (0.9% i.v. saline). Depressive symptoms were measured using the Montgomery–Asberg Depression Rating Scale (MADRS) and the Quick Inventory of Depressive Symptomatology – Self-Report (QIDS-SR). Suicidal ideation was evaluated with the QIDS-SR item 12. Adverse psychopathological effects were measured with the Brief Psychiatric Rating Scale (BPRS)-positive symptoms, Young Mania Rating Scale (YMRS) and Clinician Administered Dissociative States Scale (CADSS). Patients were assessed at baseline, 1, 2, 4, 24 and 72 h and 7, 14, 21 and 28 days. Time to response (⩾50% MADRS score reduction) was the primary outcome.ResultsBy 4 weeks, more escitalopram + ketamine-treated than escitalopram + placebo-treated patients responded (92.3% v. 57.1%, p = 0.04) and remitted (76.9% v. 14.3%, p = 0.001), with significantly shorter time to response [hazard ratio (HR) 0.04, 95% confidence interval (CI) 0.01–0.22, p < 0.001] and remission (HR 0.11, 95% CI 0.02–0.63, p = 0.01). Compared to escitalopram + placebo, escitalopram + ketamine was associated with significantly lower MADRS scores from 2 h to 2 weeks [(peak = 3 days–2 weeks; effect size (ES) = 1.08–1.18)], QIDS-SR scores from 2 h to 2 weeks (maximum ES = 1.27), and QIDS-SR suicidality from 2 to 72 h (maximum ES = 2.24). Only YMRS scores increased significantly with ketamine augmentation (1 and 2 h), without significant BPRS or CADSS elevation.ConclusionsSingle-dose i.v. ketamine augmentation of escitalopram was safe and effective in severe MDD, holding promise for speeding up early oral antidepressant efficacy.

Study of the Clinical Utility of Radioreceptor Assay in Outpatients with Schizophrenia Receiving High Doses of Neuroleptics

1993 ◽  
Vol 38 (8) ◽  
pp. 534-540 ◽  
Author(s):  
Marie-A. Gagné ◽  
Hugues Cormier ◽  
Gérard Leblanc ◽  
Daniel Lévesque ◽  
Thérèse Di Paolo
Keyword(s):  
Plasma Levels ◽  
Rating Scale ◽  
Radioreceptor Assay ◽  
High Dose ◽  
Progressive Reduction ◽  
Brief Psychiatric Rating Scale ◽  
Scale Scores ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale ◽  
High Doses

A radioreceptor assay (RRA) was used to determine the neuroleptic plasma levels of 32 outpatients with schizophrenia receiving a high dose of neuroleptics (the equivalent of 18 mg or more of oral haloperidol per day) and undergoing a 50% partial and progressive reduction (ten percent each month for five months) in their medication. Plasma levels of neuroleptics were measured three times: before (T1) and immediately after the 50% reduction (T2) and five months later (T3). A linear correlation was observed between neuroleptic plasma levels obtained by RRA and the neuroleptic doses prescribed at T1 and T3. Furthermore, neuroleptic plasma levels were significantly lower at T3 than at T1. Concurrent evaluations of psychopathology were done using the Brief Psychiatric Rating Scale, and the results indicated that no correlation exists between neuroleptic plasma levels and the total rating scale scores at T1 but a significant correlation was observed at T3.

The Efficacy of Electroconvulsive Therapy in the Treatment of Schizophrenia

1987 ◽  
Vol 151 (2) ◽  
pp. 152-155 ◽  
Author(s):  
K. R. Abraham ◽  
P. Kulhara
Keyword(s):  
Electroconvulsive Therapy ◽  
Rating Scale ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial ◽  
Brief Psychiatric Rating Scale ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale ◽  
To Receive

The efficacy of ECT was investigated in a double-blind trial. Twenty-two patients with schizophrenia received trifluoperazine and were randomly allocated to receive eight real or eight simulated ECTs. In the first eight weeks, the group receiving real ECTs showed significantly more improvement as measured on the Brief Psychiatric Rating Scale. However, the groups showed no significant differences from the twelfth week onwards. The superiority of real ECT was not confirmed at the end of six months.

scholarly journals A Prospective Pilot Study of Levetiracetam for Body Dysmorphic Disorder

CNS Spectrums ◽  
2009 ◽  
Vol 14 (5) ◽  
pp. 252-260 ◽  
Author(s):  
Katharine A. Phillips ◽  
William Menard
Keyword(s):  
Pilot Study ◽  
Body Dysmorphic Disorder ◽  
Rating Scale ◽  
Primary Outcome Measure ◽  
Obsessive Compulsive ◽  
Open Label ◽  
Double Blind ◽  
The Social ◽  
Scale Scores ◽  
The Mean

ABSTRACTIntroduction: Body dysmorphic disorder (BDD) is an often severe disorder, but few treatment studies have been conducted.Objective: This pilot study explored the efficacy and safety of the antiepileptic medication levetiracetam for BDD.Methods: Seventeen subjects with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition BDD participated in a 12-week open-label levetiracetam trial. Subjects were assessed at regular intervals with standard measures.Results: In intent-to-treat analyses, scores on the Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS), the primary outcome measure, decreased from 32.5±4.7 at baseline to 21.5±11.0 at endpoint (P<.001). Approximately 60% (n=9) of subjects were responders (≥30% decrease on the BDD-YBOCS). The mean time to response was 4.6±2.8 (range: 2-10) weeks. Scores also significantly improved on the Brown Assessment of Beliefs Scale, the Hamilton Rating Scale for Depression, the Global Assessment of Functioning Scale, and the Social and Occupational Functioning Assessment Scale. Scores did not significantly improve on the Quality of Life Enjoyment and Satisfaction Questionnaire, the Beck Anxiety Inventory, or the Social Phobia Inventory. The mean endpoint dose of levetiracetam was 2,044.1±1,065.2 (range: 250–3,000) mg/day, and it was relatively well-tolerated.Conclusion: Randomized, double-blind placebo-controlled studies of levetiracetam for BDD are needed to confirm these preliminary findings.

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.

Oxcarbazepine as an Adjunct of Antipsychotic Therapy in Acute Schizophrenia: A Double-blind, Randomised Placebo-controlled Clinical Trial

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
D. Koethe ◽  
L. Kranaster ◽  
M. Hellmich ◽  
B.M. Nolden ◽  
J. Klosterkoetter
Keyword(s):  
Rating Scale ◽  
Rate Of Change ◽  
Controlled Clinical Trial ◽  
Antipsychotic Therapy ◽  
Double Blind ◽  
Parallel Group ◽  
Significant Difference ◽  
Mixed Regression ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

The outcome in treatment of schizophrenia is still not satisfactorily, and using the adjunctive administration of various anticonvulsant drugs adjunctive to antipsychotics has become widely distributed. This study determines the efficacy of oxcarbazepine combined to olanzapine in treatment of schizophrenia in a double-blind, randomized, placebo-controlled, parallel-group, add-on therapy, 7 week study in 54 patients suffering schizophreniform disorder or schizophrenia. Patients were randomized to oxcarbazepine or placebo and titrated up to 1800 mg/ day in week 1 and maintained at that dose for another 6 weeks. Treatment of olanzapine started at week 2 with 5 mg/day. According to weekly improvement in Brief Psychiatric Rating Scale (BPRS), olanzapine dose was maintained constant or escalated in regular steps of 2.5 mg. Main outcome measure was the cumulative olanzapine dose from beginning administration of oxcarbazepine/placebo for a period of 42 days. Comparing treatment of oxcarbazepine and olanzapine with placebo and olanzapine, there was no difference in cumulative olanzapine doses in both groups. in the oxcarbazepine group was not significantly more rescue medication given. A mixed regression model was used to assess time trends in BPRS over the treatment period: the differences in the rate of change of BPRS in the two treatment groups suggested that the scores sank more rapidly in the oxcarbazepine group (p=0.063). Mean post-treatment aggression score also showed no significant difference. Results from this study do not support the use of OXC as an adjunct to atypical antipsychotics in patients with schizophrenia.

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