Robin T. Reesal

A Canadian multicenter, double-blind study of paroxetine and fluoxetine in major depressive disorder

BACKGROUND Recent studies have suggested clinical differences among selective serotonin reuptake inhibitors. In a 12-week randomized, multicenter, double-blind trial, the antidepressant and anxiolytic efficacy of the selective serotonin reuptake inhibitors paroxetine and fluoxetine was compared in patients with moderate to severe depression. METHODS A total of 203 patients were randomized to fixed doses (20 mg/day) of paroxetine or fluoxetine for the first six weeks of therapy. From week 7-12, dosing could be adjusted biweekly, as required (paroxetine 20-50 mg/day, and fluoxetine 20-80 mg/day). The mean prescribed doses were paroxetine 25.5 mg/day (range 20.0-40.2 mg/day), and fluoxetine 27.5 mg/day (range 20.0-59.5 mg/day). Emergence of motor nervousness or restlessness was assessed using the ESRS scale for akathisia. RESULTS Both active treatments demonstrated comparable antidepressant efficacy (HAM-D, CGI). Anxiolytic activity of the two drugs (COVI, STAI, HAM-D) was also comparable. However, paroxetine was found to be superior to fluoxetine on two subscore measures at week 1 of therapy (HAM-D Agitation item, p < 0.05; Psychic Anxiety item, p < 0.05), with no differences detected after week 2. The overall incidence of adverse effects was comparable in the two treatment groups. Constipation, dyspepsia, tremor, sweating and abnormal ejaculation were more common in paroxetine-treated subjects, whereas nausea and nervousness were more frequent in fluoxetine-treated patients. Weight loss was more common in the fluoxetine versus paroxetine group (11.88% versus 2.94%, respectively). ESRS scores for akathisia were low throughout the study and showed little change. LIMITATIONS Differences observed between the two drugs in antianxiety effects were limited to two measures of anxiety among several others. DISCUSSION The data indicate that paroxetine and fluoxetine have comparable antidepressant and anxiolytic efficacy. Paroxetine appears to produce an earlier improvement in agitation and psychic anxiety symptoms compared with fluoxetine.

A 12-week study comparing moclobemide and sertraline in the treatment of outpatients with atypical depression

One hundred and ninety-seven outpatients with atypical depression [Atypical Depression Diagnostic Scale (ADDS) score=4] were randomized to 12 weeks of double-blind treatment with sertraline or moclobemide in a multicentre, parallel-group clinical trial. Patients were started on either 50 mg/day sertraline or 300 mg/day moclobemide. If the therapeutic response was not satisfactoryafter 4 weeks, the dose could be increased to either 100 mg/day sertraline or 450 mg/day moclobemide. Primary effcacy evaluations were the 29-item Hamilton Psychiatric Rating Scale for Depression (HAM-D) and the Clinical Global Impression of Improvement (CGI I) response rate (much or very much improved) at study endpoint. Secondary effcacy evaluations included the ADDS, the Hamilton Anxiety Scale (HAMA), the Leeds Sleep Scale, and the Battelle Quality of Life Battery (BQOLB). In the analysis of the 172 patient effcacy-evaluable population, there was significant baseline to endpoint improvement in all primary and secondary effcacy assessments after treatment with either sertraline or moclobemide. At the endpoint, the proportion of responders on CGI-I, was 77.5% in the sertraline group and 67.5% in the moclobemide group (p=0.052). The baseline to endpoint mean 29-item HAM-D score decreased from 35.9 to 14.5 in the sertraline group and from 36.3 to 16.1 in the moclobemide group. Sertraline also resulted in a significantly (p50.05) greater degree of improvement at the endpoint, compared with moclobemide, in the proportion of remitters on the HAMA (total score47), ADDS Category IID (Rejection Sensitivity), Leeds Sleep Factor 4 (Integrity of Behaviour Following Awakening), and on three dimensions of the BQOLB (Energy/Vitality, Social Interaction and Life Satisfaction). There were no other significant differences between treatment groups. Overall, both medications were well tolerated. In this study, both sertraline and moclobemide improved the symptoms of atypical depression.

Comparison of fluoxetine and desipramine in depressed outpatients

Abstract Fifty-five moderately severe depressed patients were enrolled in a double-blind, randomized, 6-week study comparing desipramine, a potent noradrenergic compound, and the selective serotonin reuptake inhibitor fluoxetine. Of the 46 patients who completed the study, 26 received fluoxetine (mean dose, 32.2 mg/day) and 20 received desipramine (mean dose, 160 mg/day). Patients showed significant improvement on the Hamilton Depression Rating and Clinical Global Impression Scales from study initiation to termination with no statistically significant differences between drugs. Fewer side effects of less severe intensity were noted with fluoxetine compared with desipramine.

A Canadian Multicenter Study of three fixed doses of controlled-release ipsapirone in outpatients with moderate to severe major depression

Ipsapirone, an azapirone with 5-hydroxytryptamine (5-HT1A) partial agonist activity, has been shown in preliminary studies to be effective in the treatment of major depressive disorder. This 8-week, randomized, double-blind study compared the efficacy, safety, and tolerability of three fixed doses of controlled-release ipsapirone (10-, 30-, and 50-mg dose once daily) with placebo in 410 patients with moderate to severe major depression (Hamilton Rating Scale for Depression [HAM-D] score > or = 20). The 10-mg ipsapirone treatment arm was discontinued early in the study. A total of 390 patients were eligible for evaluation in the intent-to-treat sample. The primary efficacy variable was the change in HAM-D total score from baseline to visit 8. There was no significant difference in efficacy in the two treatment groups versus the placebo group. The overall treatment response, defined as a 50% decrease in the HAM-D total score from baseline, was 43% with ipsapirone 50 mg given once daily, 34% with ipsapirone 30 mg given once daily, and 35% with placebo. In subanalyses, ipsapirone 50 mg given once daily was superior to placebo according to the HAM-D Core Depression (mood, guilt, interest, psychomotor activity) subtotal (p = 0.0453) and Melancholic item (p = 0.0225). Ipsapirone 30 mg given once daily was superior to placebo only in patients with moderate depression (baseline HAM-D total score < or = 25; p = 0.0100). The most common adverse effect in all groups was headache. The only dose-dependent adverse effects were dizziness and nausea.

COMPARISON OF FLUVOXAMINE AND AMITRIPTYLINE IN DEPRESSED OUTPATIENTS

Abstract Thirty-three moderately depressed outpatients were enrolled in a double-blind, randomized 7-week study comparing fluvoxamine maleate, a selective serotonin reuptake inhibitor, with the tricyclic antidepressant amitriptyline. The mean drug dosages at the end of the study were 175 mg/day of fluvoxamine and 135 mg/day of amitriptyline. The majority of patients showed significant improvement in scores on the Hamilton Rating Scale for Depression and the Clinical Global Impression scale from study initiation to termination, with no statistically significant differences between drugs. There was no difference in the number of side effects noted with the two antidepressants, although more subjects in the amitriptyline group (6/17; 35.3%) withdrew from the study (because of adverse effects) than in the fluvoxamine group (3/16; 18.8%).

Anticipatory nausea and vomiting: a form of chemotherapy phobia?

This paper proposes that the phenomenon of anticipatory nausea and/or vomiting is a component of a phobic response to chemotherapy. Two cases are presented to highlight the clinical aspects of chemotherapy phobia. The evidence confirming such a diagnosis is put forth as it relates to anticipatory anxiety, phobic response, avoidance behaviour and treatment.

Book Review: Mood Disorders: Treating Depression Effectively: Applying Clinical Guidelines. Second EditionTreating Depression Effectively: Applying Clinical Guidelines. Second Edition: KennedySidney H, LamRaymond W, NuttDavid J, ThaseMichael E. London (GB): Informa Healthcare; 2007. 184 p. US

Trying to produce an up-to-date book is a daunting task. The authors have clearly updated the information from their past edition; however, the reader needs to be cautious about the information in certain areas such as the use of psychotropics in pregnancy. This field is ever changing. They point out an important update that pregnancy is not a protector against major depression relapse; however, they did not mention concerns about a rare but important risk of pulmonary hypertension in newborns of mothers who took selective serotonin reuptake inhibitors during pregnancy.

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The book consists of 18 chapters, divided into 5 sections: “The AAI in Clinical Context,” “Intervention Research with Mothers, Infants, and Toddlers,” “Parent–Infant Relationships, Adolescents, and Adults in Psychotherapy,” “The AAI and Trauma,” and “The AAI, Foster Care and Adoptive Placements.” This book provides a comprehensive introduction to the AAI, including its historical roots and coding system, with extensive examples of the interview components. This thorough introduction lays the foundation for the subsequent chapters, in which clinical case material from interview transcripts are presented for diverse clinical populations. The text also helps navigate the clinician in the use of the instrument to enhance assessment and diagnosis, set the agenda and goals for therapy, facilitate the therapeutic alliance, identify patient dynamics and past traumatic experiences, monitor therapeutic progress, and assess treatment outcomes. The numerous case studies are especially helpful to further illustrate how material derived from the AAI can be used to inform clinical work (for example, enhance case conceptualization).