A naturalistic open-label study of mirtazapine in autistic and other pervasive developmental disorders

OBJECTIVE: The aim of this study was to conduct a naturalistic, open-label examination of the efficacy and tolerability of mirtazapine (a medication with both serotonergic and noradrenergic properties) in the treatment of associated symptoms of autism and other pervasive developmental disorders (PDDs). METHODS: Twenty-six subjects (5 females, 21 males; ages 3.8 to 23.5 years; mean age 10.1 +/- 4.8 years) with PDDs (20 with autistic disorder, 1 with Asperger's disorder, 1 with Rett's disorder, and 4 with PDDs not otherwise specified were treated with open-label mirtazapine (dose range, 7.5-45 mg daily; mean 30.3 +/- 12.6 mg daily). Twenty had comorbid mental retardation, and 17 were taking concomitant psychotropic medications. At endpoint, subjects' primary caregivers were interviewed using the Clinical Global Impressions (CGI) scale, the Aberrant Behavior Checklist, and a side-effect checklist. RESULTS: Twenty-five of 26 subjects completed at least 4 weeks of treatment (mean 150 +/- 103 days). Nine of 26 subjects (34.6%) were judged responders ("much improved" or "very much improved" on the CGI) based on improvement in a variety of symptoms including aggression, self-injury, irritability, hyperactivity, anxiety, depression, and insomnia. Mirtazapine did not improve core symptoms of social or communication impairment. Adverse effects were minimal and included increased appetite, irritability, and transient sedation. CONCLUSIONS: Mirtazapine was well tolerated but showed only modest effectiveness for treating the associated symptoms of autistic disorder and other PDDs.     

Guanfacine treatment of hyperactivity and inattention in pervasive developmental disorders: a retrospective analysis of 80 cases

OBJECTIVE: The aim of this study was to retrospectively review a large sample of children and adolescents with pervasive developmental disorders (PDDs) treated with open-label guanfacine in order to gather preliminary data as to its effectiveness and safety. METHOD: Eighty (80) subjects with PDDs (10 females, 70 males) (mean +/- SD age = 7.7 +/- 3.5 years, range 3-18 years) were treated with guanfacine within an academic specialty clinic. Charts were reviewed to determine the response of specific target symptoms, including hyperactivity, inattention, and impulsivity. The relationship between treatment response and age, diagnosis, level of cognitive impairment, and symptom severity was determined. Adverse effects were also evaluated. RESULTS: Guanfacine (mean daily dose = 2.6 +/- 1.7 mg, range 0.25-9 mg; mean duration of treatment = 334 +/- 374 days, range 7-1776 days) treatment was effective in 19 of 80 (23.8%) subjects. Subjects with PDD not otherwise specified (11 of 28 responders; 39.3%) and Asperger's disorder (2 of 6 responders; 33.3%) showed a greater rate of global response than those with autistic disorder (6 of 46 responders; 13.0 %). There was a trend for subjects without comorbid mental retardation (9 of 24 subjects; 37.5%) to respond at a greater rate than those with mental retardation (10 of 56 subjects; 17.9%). Symptom improvement was seen in hyperactivity, inattention, insomnia, and tics. Guanfacine was well tolerated, and did not lead to significant changes in blood pressure or heart rate. CONCLUSIONS: Guanfacine may have a role in the treatment of hyperactivity and inattention occurring in some persons with PDDs. Further studies are needed to determine its efficacy in this population.     

Open-label atomoxetine for attention-deficit/ hyperactivity disorder symptoms associated with high-functioning pervasive developmental disorders

OBJECTIVE: The aim of this study was to conduct an initial evaluation of the efficacy of atomoxetine for attention-deficit/hyperactivity disorder (ADHD) symptoms in children with pervasive developmental disorders (PDDs). METHOD: Children with PDDs and a nonverbal IQ of >or=70 received atomoxetine (target dose 1.2-1.4 mg/kg/day) during the course of an 8-week, open-label, prospective study. Standardized assessments of efficacy and tolerability were collected at regular intervals during the trial. RESULTS: Sixteen children and adolescents (mean age 7.7 +/- 2.2 years, age range 6-14 years) with autistic disorder (n = 7), Asperger's disorder (n = 7), or PDD not otherwise specified (n = 2) received atomoxetine (mean dose 1.2 +/- 0.3 mg/kg/day). Twelve participants (75%) were rated as "much" or "very much improved" on the Clinical Global Impressions-Improvement scale. The most significant improvement was seen in the area of ADHD symptoms as measured by the SNAP-IV and Aberrant Behavior Checklist (effect size = 1.0-1.9). Improvements of lesser magnitude (effect size = 0.4-1.1) were seen in irritability, social withdrawal, stereotypy, and repetitive speech. There were no significant changes on the Conners' Continuous Performance Test. Atomoxetine was well tolerated with the exception of 2 participants (13 %) who stopped medication due to irritability. Weight decreased by a mean of 0.8 kg during the 8-week trial. CONCLUSIONS: Placebo-controlled studies are indicated to determine atomoxetine's efficacy for ADHD symptoms in PDDs.     

Impulsive aggressive behavior: open-label treatment with citalopram

BACKGROUND: Results from open-label and placebo-controlled trials suggest that the selective serotonin reuptake inhibitors reduce impulsive aggressive behavior. The objective of this open-label study was to investigate whether citalopram treatment has anti-aggressive effect on impulsive aggressive subjects meeting DSM-IV criteria for a cluster B personality disorder or intermittent explosive disorder. METHOD: In this 8-week trial, subjects were initiated on 20 mg/day of citalopram and titrated up to 60 mg/day by the fourth week, if tolerated. The primary outcome measure was the Overt Aggression Scale-Modified (OAS-M), a scale used to quantify verbal and physical aggression, subjective irritability, and overt irritability. Secondary outcome measures included the Barratt Impulsiveness Scale and Buss-Durkee Hostility Inventory. RESULTS: Of 25 subjects enrolled, 20 completed the study. The mean daily dose was 45.5 mg, and citalopram was generally well tolerated. Statistically significant decreases were found in the OAS-M aggression scores (32.82 +/- 19.76 to 4.73 +/- 7.57, p =.000), subjective irritability scores (3.50 +/- 0.60 to 1.45 +/- 1.18, p =.000), and overt irritability scores (3.23 +/- 0.81 to 0.91 +/- 1.02, p =.000). CONCLUSION: These results suggest that citalopram is an effective treatment for reducing impulsive aggressive behavior.     

Paroxetine in child and adolescent outpatients with panic disorder.

Paroxetine has repeatedly been shown to be effective in the treatment of panic disorder (PD) in adults, and, according to previous case observations, it may be useful in treating children and adolescents with PD as well. This preliminary naturalistic study examines effectiveness and safety of paroxetine in the treatment of children and adolescents with PD. A chart review was conducted on 18 patients with Diagnostic and Statistical Manual of Mental Disorders PD admitted to the Division of Child Neurology and Psychiatry and to the Department of Psychiatry at the University of Pisa. Paroxetine was given at an initial mean dosage of 8.9 +/- 2.1 mg/day and was gradually increased up to 40 mg/day, depending on clinical response and side effects. Clinical status was assessed with the Clinical Global Impression (CGI) and adverse effects were assessed retrospectively at each visit. Patients with final CGI-Improvement scores of 1 or 2 were considered responders. Mean paroxetine treatment duration was 11.7 +/- 8.3 months, with a mean final dosage of 23.9 +/- 9.8 mg/day (range, 10-40 mg/day). No patient had to interrupt the treatment because of side effects. Fifteen patients (83.3%) were considered responders. The mean change on the CGI-Severity scale was statistically significant (p < 0.0001). Paroxetine was well tolerated and effective in the treatment of PD in these children and adolescents.     

Pemoline treatment of adolescents with attention deficit hyperactivity disorder: a short-term controlled trial

BACKGROUND: Despite the increased recognition of attention deficit hyperactivity disorder (ADHD) in adolescents, few controlled studies have assessed treatments for this age group. Adolescent issues, such as embarrassment at receiving medication at school and experimentation with abusable substances, have accelerated efforts to find effective, well-tolerated treatments beyond traditional stimulants. Pemoline has been found effective for treating both children and adults with ADHD but has not been evaluated in adolescents with ADHD. METHODS: Twenty-one adolescents (mean age 14 years old) diagnosed with ADHD by structured and clinical interviews participated in a 10-week, double-blind crossover design study of pemoline. Dosing was optimized with robust doses up to 3 mg/kg/day in one to two doses. Clinical evaluations of ADHD, depression, anxiety, and oppositional defiant disorder (ODD) symptoms were assessed weekly. RESULTS: Adolescents with ADHD exhibited a marked response to pemoline treatment relative to placebo on the ADHD rating scale (p = 0.001), with an average reduction of 3.02 points per week of treatment. Sixty percent of adolescents responded to pemoline, compared to 11% treated with placebo. This response was independent of gender or lifetime psychiatric comorbidity. Pemoline was well tolerated, with patients averaging 2.88 mg/kg/day in two doses per day, with a mean dose at end of follow-up of 181.1 mg (SD 45.6, range 112.5-262.5 mg). Side effects were mild, and no adverse hepatic events occurred. CONCLUSIONS: These findings resemble those reported in children and adults with ADHD. This trial suggests pemoline is well tolerated and effective in adolescents and may be a particularly useful ADHD treatment for adolescents.     

Citalopram treatment of children and adolescents with obsessive-compulsive disorder: a preliminary report

The purpose of the present study was to assess the efficacy and tolerability of citalopram in the acute treatment of children and adolescents with obsessive compulsive disorder (OCD) during an 8-week, open-label study. Fifteen patients (six female, nine male) with a mean age of 12.1 +/- 3.3 years (range: 6-17 years) were treated with citalopram (range of dose: 20-30 mg/day, mean dose: 24 +/- 5.5 mg/day). The children's version of the Yale-Brown Obsessive-Compulsive scale (CY-BOCS) was rated at the baseline, at the 4th week and at the 8th week of treatment. Fourteen patients had a decrease in total score of CY-BOCS from baseline to the 4th week of treatment (P < 0.01) and the 8th week of treatment (P < 0.01). Sedation (n = 1) and insomnia (n = 1) were reported in the first weeks of treatment. The primary data suggest the efficacy and tolerability of citalopram in young patients with OCD.     

Citalopram treatment for impulsive aggression in children and adolescents: an open pilot study

OBJECTIVE: To assess the short-term effect and safety of citalopram in the reduction of impulsive aggression in children and adolescents. METHOD: Twelve subjects, aged 7 to 15 years, were attending a psychiatric outpatient clinic and had a profile of impulsive aggression. Subjects were treated in an open trial with citalopram for 6 weeks after a 1-week washout period. Dosage was regulated individually over a period of 4 weeks. The starting dose was 10 mg/day followed by 10 mg increments on a weekly basis. The maximum dose was not to exceed 40 mg/day. Outcome measures included the Modified Overt Aggression Scale (MOAS), the Child Behavioral Checklist (CBCL), and the Clinical Global Impressions (CGI). RESULTS: Eleven subjects completed the study Citalopram produced clinically and statistically significant reductions on target symptoms of impulsive aggression, independent of other behavioral problems, as measured by the MOAS, the CBCL, and the CGI at doses ranging from 20 to 40 mg/day (mean = 27 mg). No major adverse reactions were associated with citalopram use. CONCLUSION: Citalopram appears to be effective and well tolerated in this sample of children and adolescents with impulsive aggression.     

A naturalistic retrospective analysis of psychostimulants in pervasive developmental disorders

OBJECTIVE: We set out to examine the effectiveness and tolerability of psychostimulants in children and adolescents with pervasive developmental disorders (PDDs). METHODS: Medical records of all patients with PDDs treated with a stimulant were retrospectively reviewed. Demographics, stimulant type, drug dosage, trial duration, and adverse effects were recorded. Global improvement, focused on symptoms of hyperactivity and inattention, was measured by the Clinical Global Impressions-Improvement scale, with positive response defined by a rating of much improved or very much improved. RESULTS: Of 195 patients (174 males, 21 females; mean age +/- SD = 7.26 +/- 3.45 years, range 2-19 years), 61 had more than one trial, resulting in a total of 274 separate stimulant trials. It was discovered that 24.6%, 23.2%, and 11.1% of patients with a history of one, two, or three stimulant trials, respectively, responded to their first stimulant trial. Among first trial nonresponders, 6 (14.0%) of 43 patients responded to a second trial. Of those who did not respond to their first or second stimulant trial, 2 (14.3%) of 14 patients responded to a third trial. Patients with Asperger's disorder, in contrast to those with autistic disorder or PDD not otherwise specified, were significantly more likely to respond to a stimulant trial (p < 0.01). Use of concomitant medication (p < 0.007) positively affected response, whereas no association was found between stimulant type and IQ and response. Adverse effects, including agitation, dysphoria, and irritability, often occurred (154 [57.5%] of 268 trials, with 6 missing values). CONCLUSIONS: Overall, stimulants appeared ineffective and poorly tolerated for the majority of patients with PDDs. Response may differ with PDD subtype. Controlled studies are needed to further evaluate these preliminary findings in a systematic manner.     

Oxcarbazepine monotherapy in children and adolescents: a single-center clinical experience

This single-center analysis evaluated the efficacy of oxcarbazepine monotherapy in children and adolescents. A retrospective chart review identified 60 patients (male=33, female=27) aged 6 months to 17.8 years (mean age 8.2+/-4.7 years) with partial onset epilepsy receiving oxcarbazepine monotherapy. The range of oxcarbazepine dose was 6-71 mg/kg/day (mean 26.3+/-11.4 mg/kg/day). The duration of therapy ranged from 3 months to 8 years (mean duration 16.7+/-14.3 months). Fifty-one patients (85%) achieved>or=50% reduction in seizure frequency, and 25 of 60 patients (42%) achieved seizure freedom. Ten patients (16.67%) reported adverse events including drowsiness, aggressive behavior, ataxia, dizziness, diplopia, and leg cramps. No hyponatremia or skin rash was observed. Twenty-four patients were switched from carbamazepine to oxcarbazepine monotherapy. In these patients carbamazepine was discontinued because of incidence of adverse events, poor seizure control, or both. Seventy-nine percent of patients switched from carbamazepine to oxcarbazepine monotherapy had >or=50% reduction in seizure frequency, and 37.5% became seizure-free. These findings suggest that oxcarbazepine monotherapy is effective and well tolerated in children and adolescents with partial epilepsy.     

Adjunctive topiramate treatment for pediatric bipolar disorder: a retrospective chart review

OBJECTIVE: The objective of this study was to evaluate the effectiveness, safety, and tolerability of the anticonvulsant agent, topiramate, as adjunctive treatment for children and adolescents with bipolar disorders. METHODS: The outpatient medical charts of children and adolescents with a Diagnostic and Statistical Manual of Mental Disorders (4th ed.) diagnosis of bipolar disorder, type I or II, and who were treated with topiramate were retrospectively reviewed by two child and adolescent psychiatrists using the Clinical Global Impression (CGI) scale and the Clinical Global Assessment Scale (CGAS). Separate CGI ratings were made for mania and overall bipolar illness. RESULTS: Twenty-six patients (mean age 14 +/- 3.5 years) with bipolar disorder, type I (n = 23) or II (n = 3), who had been treated (mean duration 4.1 +/- 6.1 months) with topiramate (mean dose 104 +/- 77 mg/day) were identified. Response rate (defined by a CGI-Improvement score of < or = 2 at endpoint) was 73% for mania and 62% for overall illness. CGAS scores significantly improved from baseline to endpoint. No serious adverse events were reported. CONCLUSIONS: Although controlled trials are necessary, this retrospective study suggests that topiramate is effective and well tolerated as an adjunctive treatment for children and adolescents with bipolar disorder.     

A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents

OBJECTIVE: Open-label trials with the selective serotonin reuptake inhibitor citalopram suggest that this agent is effective and safe for the treatment of depressive symptoms in children and adolescents. The current study investigated the efficacy and safety of citalopram compared with placebo in the treatment of pediatric patients with major depression. METHOD: An 8-week, randomized, double-blind, placebo-controlled study compared the safety and efficacy of citalopram with placebo in the treatment of children (ages 7-11) and adolescents (ages 12-17) with major depressive disorder. Diagnosis was established with the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version. Patients (N=174) were treated initially with placebo or 20 mg/day of citalopram, with an option to increase the dose to 40 mg/day at week 4 if clinically indicated. The primary outcome measure was score on the Children's Depression Rating Scale-Revised; the response criterion was defined as a score of < or =28. RESULTS: The overall mean citalopram dose was approximately 24 mg/day. Mean Children's Depression Rating Scale-Revised scores decreased significantly more from baseline in the citalopram treatment group than in the placebo treatment group, beginning at week 1 and continuing at every observation point to the end of the study (effect size=2.9). The difference in response rate at week 8 between placebo (24%) and citalopram (36%) also was statistically significant. Citalopram treatment was well tolerated. Rates of discontinuation due to adverse events were comparable in the placebo and citalopram groups (5.9% versus 5.6%, respectively). Rhinitis, nausea, and abdominal pain were the only adverse events to occur with a frequency exceeding 10% in either treatment group. CONCLUSIONS: In this population of children and adolescents, treatment with citalopram reduced depressive symptoms to a significantly greater extent than placebo treatment and was well tolerated.     

Effectiveness and tolerability of citalopram for the treatment of depression and anxiety disorders in children and adolescents: an open-label study

To assess the effectiveness and tolerability of citalopram for the acute treatment of children and adolescents suffering from depression and/or anxiety disorders. As much as 78 outpatients, aged 7–18 years with a diagnosis of depressive and/or anxiety disorder, completed an 8-week open trial with citalopram (20–40 mg/day). Outcome, side effects and suicidality were assessed weekly to bi-weekly using appropriate rating scales. At endpoint 56% of subjects were found to be responders (Clinical Global Impression-Improvement [CGI-I] Scale ≤ 2). Subjects with less severe psychopathology and subjects with anxiety disorders showed a more favorable response. As much as 43% of depressed and 51% of anxious subjects had a 50% or greater reduction in scores on our secondary outcome measures, Children’s Depression Rating Scale-Revised (CDRS-R) and Screen for Child Anxiety Related Emotional Disorders (SCARED). Most reported adverse events were mild to moderate and did not affect medication adherence. No increase in suicidality was observed during the study. Citalopram was moderately effective, generally well tolerated and safe for the acute treatment of depressed and anxious children and adolescents.     

Risperidone-induced prolactin elevation in a prospective study of children, adolescents, and adults with mental retardation and pervasive developmental disorders

OBJECTIVE: Risperidone is widely prescribed for aggression and self-injury in children, adolescents, and adults with mental retardation (MR) and pervasive developmental disorders (PDD). Risperidone elevates prolactin more than other atypical antipsychotic medications. Females may show greater prolactin elevation than males. METHOD: In this relatively long-term study of risperidone efficacy and safety for aggression and self-injury in children, adolescents, and adults with MR and PDDs, serum prolactin was measured in a 21-subject subset during the course of a double-blind, placebo-controlled trial. Prolactin was measured in ng/mL at baseline, once during acute treatment, and once during maintenance. RESULTS: In children and adolescents (n=10), mean age of 12.5 years, prolactin increased from mean 13.2+/-8.6 at baseline to 31.0+/-11.6 acutely and remained elevated at 37.9+/-10.4 in maintenance. In adults, mean age of 35.3 years, prolactin increased more markedly from 11.6+/-7.4 baseline (n=11) to 93.3+/-54.2 acutely but decreased to 67.8+/-62.9 in maintenance (n=7). Prolactin remained significantly elevated above normal in all subjects for at least 26 weeks. Mean prolactin of adult females, while similar to that of adult males at baseline, was 2.2 times male levels acutely and 3.7 times greater in maintenance. CONCLUSION: In this small subset, mean prolactin elevation persisted for at least 26 weeks. In adults, females showed significantly greater elevations than males.     

The effectiveness and tolerability of aripiprazole for pediatric bipolar disorders: a retrospective chart review

OBJECTIVE: The aim of this retrospective chart review was to evaluate the effectiveness and tolerability of aripiprazole for the treatment of children and adolescents with bipolar disorders. METHODS: The medical charts of all children and adolescents with a DSM-IV diagnosis of bipolar disorder, type I, type II, not otherwise specified (NOS), or schizoaffective disorder, bipolar type, and who were treated with aripiprazole were reviewed by two child and adolescent psychiatrists who independently confirmed their DSM-IV diagnoses, severity, and the improvement of illness using the Clinical Global Impression (CGI) Severity and Improvement scores for bipolar disorder (CGI-BP) and the Clinical Global Assessment Scale (CGAS). RESULTS: Thirty patients who were treated with aripiprazole were identified (mean starting dose=9 +/- 4 mg/day, mean final dose=10 +/- 3 mg/day). The overall response rate, defined by a CGI-Improvement score of < or = 2 at endpoint, was 67%. There was a statistically significant improvement in CGAS scores (48 +/- 11 to 65 +/- 11, signed rank = 191, p <0.0001) and CGI-S scores (4.2 +/- 0.8 to 2.8 +/- 1.0, signed rank=-172, p <0.0001, effect size=1.90) from baseline to endpoint. No serious adverse events were identified. Common side effects were sedation (n=10, 33%), akathisia (n=7, 23%), and gastrointestinal disturbances (n=2, 7%). Baseline and endpoint weights were available for 14 (47%) of the patients. Change in weight ranged from +5 to -21 kg and 12 (86%) of 14 patients lost weight (mean weight loss was 3 +/- 6 kg). CONCLUSIONS: This retrospective chart review suggests that aripiprazole may be effective and well tolerated for children and adolescents with bipolar disorders. Controlled studies of aripiprazole for the treatment of pediatric bipolar disorder are necessary.     

Clinical experience with Topiramate to counteract neuroleptic induced weight gain in 10 individuals with autistic spectrum disorders

Children and adolescents with autistic spectrum disorders are treated with neuroleptics to limit behavioral disturbances such as aggression, hyperactivity and self-injury. They may experience substantial weight gain when undergoing treatment with atypical antipsychotics actually employed. Topiramate (TPM) is an antiepileptic medication that is being progressively demonstrating a wider spectrum of action, mainly as an agent for weight control and as a mood stabilizer. It was administered to a group of children and adolescents with autistic spectrum disorders with the aim of reversing weight gain. This is an open study over an observation period of 18 months of 10 children and adolescents, eight males and two females, mean age 13 years, SD+/-3.6, range 8-19 years with a diagnosis of autistic disorder or pervasive developmental disorder not otherwise specified according to DSM-IV. Starting dosage of TPM was 0.5 mg/kg followed by titration of 0.5 mg/kg on a weekly basis, up to 1-3 mg/kg/day as the maintenance dosage. Eight subjects were undergoing long-term treatment with risperidone, one with pimozide and one was temporarily not on antipsychotics. Six patients took TPM on a regular basis and four dropped out. Variable degrees of weight reduction were observed in four patients, two subjects showed weight increase. Behavioral adverse effects were observed in three patients causing rapid withdrawal of the medication. TPM should be used with caution in autistic spectrum disorders because this population has a high risk of behavioral disruption.     

Olanzapine in the treatment of aggression and tics in children with Tourette's syndrome--a pilot study

OBJECTIVE: The aim of this study was to examine the effects of olanzapine on aggressive behaviour and tic severity in children with Tourette's Syndrome (TS). METHOD: Ten (10) subjects (aged 7-13 years) with a primary diagnosis of TS and a history of aggressive behaviour were treated in a single-blind, 2-week placebo run-in, 8-week treatment phase trial. The starting dose of olanzapine was 1.25-2.5 mg/day and was titrated at biweekly intervals, as tolerated. The mean dosage at the end of the trial was 14.5 mg/day. RESULTS: All 10 subjects completed the study. Olanzapine produced clinically and statistically significant reductions of aggression and tic severity from baseline to trial completion, as measured by the Achenbach Child Behavior Checklist (CBCL) and Yale Global Tic Severity Scale (YGTSS). Weight gain during the treatment period was the most common adverse effect (range 2-20 lbs: group mean 12.0 lbs +/- 5.71). No other significant adverse effects were observed during the 10-week trial. CONCLUSION: The results of this trial confirm clinical observations that olanzapine may be an effective treatment for aggression and tics in children with Tourette's syndrome. Olanzapine was generally well tolerated, although significant weight gain was observed throughout the trial.     

Case series: use of ziprasidone for maladaptive symptoms in youths with autism

OBJECTIVE: To conduct a preliminary evaluation of the safety and effectiveness of ziprasidone in children, adolescents, and young adults with autism. METHOD: Twelve patients (mean age +/- SD, 11.62 +/- 4.38 years; range, 8-20 years) with DSM-IV-defined autism (n = 9) or pervasive developmental disorder not otherwise specified (n = 3) received open-label treatment with ziprasidone (mean daily dose, 59.23 +/- 34.76 mg; range, 20-120 mg) for at least 6 weeks (mean duration, 14.15 +/- 8.29 weeks; range, 6-30 weeks). RESULTS: Six (50%) of the 12 patients were considered responders based on a Clinical Global Impression Scale rating of "much improved" or "very much improved." Transient sedation was the most common side effect. No cardiovascular side effects, including chest pain, tachycardia, palpitations, dizziness, or syncope, were observed or reported.The mean change in body weight for the group was -5.83 +/- 12.52 lb (range, -35 to +6 lb). Five patients lost weight, five had no change, one gained weight, and one had no follow-up weight obtained beyond the baseline measurement. CONCLUSIONS: Ziprasidone appears to have the potential for improving symptoms of aggression, agitation, and irritability in children, adolescents, and young adults with autism. Significant weight gain was not observed in this short-term trial. Double-blind, placebo-controlled studies are needed to substantiate these preliminary findings.     

Safety and efficacy of oral escitalopram as continuation treatment of intravenous citalopram in patients with major depressive disorder

The objective of this open-label, multicentre study was to evaluate the safety and efficacy of treatment with escitalopram (10 or 20 mg/day) for 6 weeks following a switch from intravenous citalopram treatment (20 or 40 mg/day) in patients presenting with a major depressive episode. A total of 173 patients were included, 147 (85%) of whom completed the study. The mean Montgomery-Asberg Depression Rating Scale (MADRS) total score at inclusion (last citalopram dose) was 31.6 +/- 9.9. The MADRS score decreased to 23.4 +/- 10.5 after 3 days of oral treatment with escitalopram and was 12.7 +/- 9.3 at the end of the study. The scores on the Clinical Global Impression (CGI) and Patient Global Evaluation scales also improved: at the end of the study, the response rates were 67% on the MADRS (defined as >or=50% decrease from MADRS baseline score) and 68% on the CGI-I (defined as CGI-I 相似文献   

西酞普兰与帕罗西汀治疗广泛性焦虑对照研究

目的:探讨西酞普兰治疗广泛性焦虑的疗效及安全性。方法:将80例广泛性焦虑患者随机分为西酞普兰组及帕罗西汀组各40例,2药治疗剂量均为20～40mg/d。疗程4周。用Hamilton焦虑量表(HAMA)、焦虑自评量表(SAS)及治疗中出现的症状量表(TESS)评定疗效及不良反应。结果:西酞普兰组有效率为85.0%,帕罗西汀组为87.5%,两组疗效相当(P>0.05)。西酞普兰组不良反应较帕罗西汀组少且轻微,患者依从性好。结论:西酞普兰是一种安全、有效的抗焦虑药。