Biomedical subjects

Maurizio Fava

Publications and source records attributed to Maurizio Fava.

At least 127 records · Page 7Linked to original sources

PubMed2003

Nortriptyline for treatment-resistant depression.

BACKGROUND: Up to 30% of patients with major depression fail to respond to an antidepressant trial, with most taking a selective serotonin reuptake inhibitor (SSRI) as initial treatment. While the tricyclic antidepressants might be effective for SSRI nonresponders, they have been relegated to third- and fourth-line treatment. This study assesses the efficacy of nortriptyline for patients with treatment-resistant major depression. METHOD: 92 patients with treatment-resistant DSM-III-R major depression, with resistance defined by at least 1, but no more than 5, well-documented adequate trials of antidepressants during the current episode, were treated openly with nortriptyline for 6 weeks. Patients were titrated up to full target doses of nortriptyline within 1 week, with target blood levels of 100 ng/mL. Response was defined as a 50% or greater decrease of baseline 17-item Hamilton Rating Scale for Depression score. We performed an intent-to-treat analysis with the last observation carried forward. RESULTS: Approximately 40% of patients were responders (N = 39) and 12% were remitters (N = 11) after 6 weeks of nortriptyline. Over a third of patients were unable to complete the trial. CONCLUSION: Nortriptyline was effective for over a third of patients with treatment-resistant depression, and nortriptyline should be considered as potential treatment if patients fail to respond to other antidepressants.

Adolescent↗

PubMed2003

Psychiatric comorbidity as a predictor of clinical response to nortriptyline in treatment-resistant major depressive disorder.

BACKGROUND: A number of studies of major depressive disorder suggest that psychiatric co-morbidity may contribute to treatment resistance. The purpose of this study was to test whether the presence of comorbid Axis I and Axis II disorders predicts clinical response to an open trial of nor-triptyline among patients with treatment-resistant depression. METHOD: Ninety-two outpatients with treatment-resistant DSM-III-R major depressive disorder were enrolled in a 6-week open trial of nor-triptyline (Nov. 1992-Jan. 1999). The presence of comorbid Axis I and Axis II disorders was established at baseline with the use of the Structured Clinical Interview for DSM-III-R. Chi-square analyses were used to test Axis I or Axis II co-morbid conditions as a predictor of clinical response to nortriptyline. RESULTS: Thirty-nine patients (42.4%) responded to nortriptyline. The presence of avoidant personality disorder (p <.01) predicted poorer response to nortriptyline. The response rate was 16.7% for patients with and 48.6% for patients without comorbid avoidant personality disorder. No other comorbid diagnoses were found to predict clinical response in a statistically significant manner. CONCLUSION: The presence of avoidant personality disorder conferred a poorer prognosis in treatment-resistant depression patients treated with nortriptyline.

Adolescent↗

PubMed2003

Depression with physical symptoms: treating to remission.

Depression is a recurrent, often chronic disease consisting of psychological and physical symptoms that are frequently undiagnosed or inadequately treated. While psychological symptoms have been shown to respond to current antidepressants, physical symptoms may not be as responsive. Treating both psychological and physical symptoms of depression may lead to a higher percentage of patients reaching remission.

Antidepressive Agents↗

PubMed2003

The role of the serotonergic and noradrenergic neurotransmitter systems in the treatment of psychological and physical symptoms of depression.

Major depressive disorder is a medical condition that includes abnormalities of affect and mood, cognition, and physical functioning. In particular, as many as 76% of patients suffering from depression are found to report somatic symptoms, including various types of pain such as headaches, stomach pain, back pain, and vague, poorly localized pain. Although the pathophysiology of depression is still unknown, there is significant evidence for abnormalities of the norepinephrine (NE) and serotonin (5-HT) neurotransmitter systems in depressive disorders. Interestingly, both 5-HT and NE also appear to exert analgesic effects via descending pain pathways and therefore play a modulating role in pain. There are many effective antidepressant treatments available. However, residual symptoms are relatively common, among both partial responders and responders without remission. A recent study from our group has shown that responders who have not achieved remission have significantly more somatic symptoms than remitters following 8 weeks of treatment with fluoxetine. These data may suggest that antidepressants that are particularly effective in the treatment of pain and painful physical symptoms may yield higher remission rates in major depressive disorder.

Adrenergic Uptake Inhibitors↗

PubMed2003

Symptoms of fatigue and cognitive/executive dysfunction in major depressive disorder before and after antidepressant treatment.

Patients with major depressive disorder commonly experience fatigue and cognitive/executive dysfunction. These problems may be symptoms of the depression and persist despite effective antidepressant treatment, or these problems may emerge as adverse effects of some antidepressant treatments. A number of augmentation strategies can be employed to manage fatigue or cognitive/executive dysfunction, but the efficacy of these augmentation strategies must be researched further.

Cognition Disorders↗

PubMed2002

An open pilot study of nefazodone in depression with anger attacks: relationship between clinical response and receptor binding.

Nefazodone has been widely used as an antidepressant, but it has not been tested for depression with anger attacks. In an open study, we administered nefazodone (maximum 600 mg/day) for 12 weeks to 16 outpatients who had major depression with anger attacks. Assessment instruments comprised the Structured Clinical Interview for DSM-IV (SCID), Anger Attacks Questionnaire (AAQ), 17-item Hamilton Rating Scale for Depression (HAM-D-17), Clinician Global Impression Scale (CGI), Symptom Questionnaire (SQ), Modified Overt Aggression Scale (MOAS), and MOAS-Self-Rated. Three subjects underwent positron emission tomography (PET) with [18F]-setoperone for 5-HT2 binding potential (BP) and [11C]-SCH-23,390 for D1 BP, both at baseline and after 6 weeks of treatment. Eight subjects underwent PET with [18F]-setoperone and with [11C]-SCH-23,390 at baseline only. In an examination of whether D1 and 5HT2 (data available in six subjects) receptor BP predicted treatment response, we found significant decreases in the HAM-D-17, CGI-S, weighted MOAS, MOAS verbal scale, OAS Self-Rated verbal, SQ Depression and Anger/Hostility scales after nefazodone; 50% responded to nefazodone (defined as >or=50% decrease in HAM-D-17 score), and 44% reported disappearance of anger attacks. A statistically significant percentage decrease in 5HT2 BP was observed for the right mesial frontal and left parietal regions after 6 weeks of treatment. No significant change was observed in D1 BP in any region. Although CGI-I scores correlated significantly with D1 BP in the left thalamic region, the correlation was not significant after Bonferroni correction. The effectiveness of nefazodone for depression with anger attacks may be related to widespread changes in 5HT2 receptor BP.

Adult↗

PubMed2002

NEO-FFI factor scores as predictors of clinical response to fluoxetine in depressed outpatients.

Research in unipolar depression suggests that neuroticism is associated with poor long-term outcome and greater chronicity. The objective of this study was to determine whether baseline neuroticism scores predict response to treatment with fluoxetine in depressed outpatients. Seventy-six depressed outpatients participating in a clinical trial of fluoxetine (fixed/flexible dosing) completed the NEO-FFI (five factor inventory short form) at baseline. Clinical response was defined as a 50% or greater decrease in the 17-item Hamilton Depression Rating Scale (HAM-D-17) total score (final visit--baseline). Logistic regression evaluated NEO-FFI factor scores as predictors of treatment outcome within an intent-to-treat model. Scores on the neuroticism scale were not found to significantly predict treatment response as measured by the HAM-D-17. Strengths of this study include a standardized treatment protocol and use of structured interview instruments, while limitations include a modest sample size, lack of continuation data, state/trait effects, and lack of generalizability to other antidepressant treatments.

Adolescent↗

PubMed2002

Depression and public health: an overview.

Depressive disorders are a significant public health issue. They are prevalent, disabling, often chronic illnesses, which cause a high economic burden for society, related to both direct and indirect costs. Depressive disorders also influence significantly the outcome of comorbid medical illnesses such as cardiac diseases, diabetes, and cancer. In primary care, underrecognition and undertreatment of depressive disorders are common, despite their relatively high prevalence, which accounts typically for more than 10% of patients. Primary care physicians should be aware of the common risk factors for depressive disorders such as gender, neuroticism, life events and adverse childhood experiences, and they should be familiar with associated features such as a positive psychiatric family history and prior depressive episodes. In primary care settings, depressive disorders should be considered with patients with multiple medical problems, unexplained physical symptoms, chronic pain or use of medical services that is more frequent than expected. Management of depressive disorders in primary care should include treatment with the newer antidepressant agents (given the fact they are typically well tolerated and safe) and focus on concomitant unhealthy behaviors as well as treatment adherence, which may both affect patient outcome. Programs aimed at improving patient follow-up and the coordination of the primary care intervention with that of specialists have been found to improve patient outcomes and to be cost effective.

Activities of Daily Living↗

PubMed2002

Depression, antidepressant therapies, and erectile dysfunction: clinical trials of sildenafil citrate (Viagra) in treated and untreated patients with depression.

Erectile dysfunction (ED) and depression are highly prevalent conditions and frequently occur concomitantly in predisposed individuals. Men with ED and depression are also likely to have other comorbid conditions, including diabetes, hypertension, and heart disease. Because ED is also a common adverse effect of some medications for these conditions, patients are frequently noncompliant with treatment. Sildenafil citrate (Viagra) is effective in treating ED of a broad range of etiologies, suggesting that it may be equally beneficial in patients with ED that is associated with depressive symptoms and in those with ED resulting from serotonergic reuptake inhibitor (SRI) antidepressant treatment. We review the results of 3 randomized, placebo-controlled trials and a retrospective analysis of data pooled from 10 clinical trials that examine the efficacy of sildenafil in treating ED associated with depression and as an adverse effect of SRI treatment. The results suggest that sildenafil is efficacious as a first-line treatment for ED in men with untreated minor depression, in men with ED that is refractory to successful SRI treatment of depression, and in those whose depression was successfully treated but who developed ED as a consequence of SRI treatment. Given the complex interrelations among ED, depression, and other comorbid conditions, the key to proper management is a comprehensive evaluation, including sexual function, and an accurate differential diagnosis.

Antidepressive Agents, Second-Generation↗

PubMed2002

Body dysmorphic disorder in outpatients with major depression.

BACKGROUND: Body dysmorphic disorder (BDD) is a distressing and impairing preoccupation with an imagined or slight defect in appearance, with depression as its most frequent comorbid condition. The purpose of this study was to evaluate the rate of BDD in a cohort of consecutive outpatients with typical and atypical major depressive disorder. METHODS: Three hundred and fifty consecutive outpatient subjects with major depression who entered an antidepressant treatment study were evaluated drug-free with the SCID-P, SCID-II, a diagnostic module for BDD, and other measures. Depressed subjects with comorbid BDD were compared to those without BDD with regard to demographics, course of depression, comorbid conditions, and other relevant variables. RESULTS: Twenty-eight (8.0%) subjects had a lifetime history of BDD and 23 (6.6%) had current BDD. Those with comorbid lifetime BDD had an earlier age of onset of depression and longer duration of the current episode, but not a greater number of depressive episodes or greater severity of depression. Subjects with and without BDD were similar with respect to age, gender, and marital status. There was a higher rate of lifetime and current BDD in subjects with atypical depression than in those with non-atypical depression (14.4% compared to 5.1%; chi2 = 6.63; P = 0.01: 11.6% vs. 4.1%; chi2 = 7.02; P = 0.02). Subjects with BDD also had higher rates of social phobia, any eating disorder, and any somatoform disorder but not obsessive compulsive disorder. They also had higher rates of avoidant, histrionic, and dependent personality disorders. LIMITATIONS: As we did not specifically examine bipolar spectrum conditions, the present study cannot address to what extent BDD is comorbid with Bipolar-II disorder. CONCLUSIONS: BDD is frequently comorbid with major depression, is associated with an earlier age of onset of depression and longer duration of depressive episodes, and is found more frequently with atypical than non-atypical depression.

Adolescent↗

PubMed2002

A survey of prescribing practices in the treatment of depression.

BACKGROUND: With the increasing number and type of antidepressants available to clinicians, there is a need to better understand current prescribing practices and to what degree these practices reflect research findings. The purpose of this study was to examine prescribing practices in a sample of psychiatrists attending a psychopharmacology review course and compare these results with empirical evidence. METHOD: 439 of 800 clinicians asked (55%) responded to a 10-item questionnaire that was given prior to beginning the review course. Items covered three major content areas: first-line preferences in the treatment of depression, antidepressant agents most associated with certain side effects, and first-line preferences in the treatment of certain depressive subtypes. RESULTS: 214 (49%) clinicians indicated a belief that one antidepressant type is more efficacious than others. Of these 214 clinicians, 103 (48%) indicated selective serotonin reuptake inhibitors (SSRIs) as being most efficacious, while 53 (25%) indicated venlafaxine as being most efficacious; 378 (93%) clinicians indicated SSRIs as their first-line treatment preference. Mirtazapine (56%) was endorsed as most likely to be associated with weight gain, fluoxetine (57%) with sexual dysfunction, paroxetine (48%) with a discontinuation syndrome, and fluoxetine (52%) with agitation. For the treatment of anxious, atypical, and melancholic depression, SSRIs were the first choice of treatment (58%, 57%, and 57%), and for depression with prominent insomnia, mirtazapine and nefazadone (31% and 27%) were the first choices of treatment. CONCLUSIONS: Despite the lack of evidence of a significant difference in efficacy between older and newer agents, clinicians perceive the newer agents to be more efficacious than the older drugs [tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs)] even in the melancholic and anxious depressive subtypes. Similarly, although sexual dysfunction and agitation appear to occur at similar rates with all the SSRIs, fluoxetine was perceived to be most likely to cause these side effects. These findings are significant as they highlight the discrepancy between empirical evidence and clinical practices and suggest that other factors influence clinicians' medication choices in the treatment of depression.

Antidepressive Agents↗

PubMed2002

Early drop-outs, late drop-outs and completers: differences in the continuation phase of a clinical trial.

OBJECTIVE: The purpose of this study was to assess the differences between early and late drop-outs and completers in the continuation phase of a clinical trial. METHODS: The authors studied 119 outpatients who were treatment responders in an 8-week open trial with fluoxetine 20 mg/day, and who were then enrolled in a 26-week clinical trial comparing the efficacy of fluoxetine versus fluoxetine and cognitive behavior therapy (CBT). Patients were assessed using the Structured Clinical Interview for DSM-III-R--Axis I (SCID-Patient Edition), Hamilton Depression Rating Scale (HAMD-17) and the following self-rated scales: Beck Depression Inventory (BDI), Beck Hopelessness Scale (BHS), Anxiety Sensitivity Index (ASI) and the Symptom Questionnaire (SQ) prior to starting the 26-week continuation phase. We defined "early drop-outs" (EDs) as patients who dropped out either at or prior to Visit 2 (which was at 2 months into the 6-month continuation phase); those dropping out at Visit 3 or later were defined as "late drop-outs" (LDs) (ED < or = 2 months; LD >2 months). The Kruskal-Wallis and the Mann-Whitney U tests were used for data analysis. RESULTS: Of the 119 patients, 83 were completers (mean age: 42.1+/-9.0 years; 46 [55%] women; age of onset of major depressive disorder [MDD] = 24.3+/-12.5 years), II were EDs (mean age: 38.1 + 13.0 years: 4 [36%] women; age of onset of MDD = 22.0+/-11.1 years) and 25 were LDs (mean age: 35.2+/-10.4 years; 12 [48%] women; age of onset of MDD = 24.6+/-11.6 years). LDs were significantly younger than completers (P<.01). There was no significant difference in age between EDs and LDs, nor between EDs and completers. EDs were more likely to have been depressed for a longer period of time compared to LDs (P< .05). EDs completers were depressed for a longer period of time compared to LDs (P< .05). CONCLUSIONS: Our data suggest that late drop-outs are significantly younger than completers, although age is not a predictor between early drop-outs and late drop-outs. Further, early drop-outs are depressed for a longer duration compared to late drop-outs completers are depressed for a longer duration than late dropouts, and Early drop-outs have significantly more social impairment compared to completers. Our study identified some patient characteristics significantly associated with dropping out of a long-term clinical trial.

Adolescent↗

PubMed2002

Early drop-outs, late drop-outs and completers: differences in the continuation phase of a clinical trial.

OBJECTIVE: The purpose of this study was to assess the differences between early (EDs), late drop-outs (LDs) and completers in the continuation phase of a clinical trial. METHODS: The authors studied 119 outpatients who were treatment responders in an 8-week open trial with fluoxetine 20 mg/day, and who were then enrolled in a 26-week clinical trial comparing the efficacy of fluoxetine versus fluoxetine and cognitive behavior therapy (CBT). Patients were assessed using the Structured Clinical Interview for DSM-III-R-Axis I (SCID-Patient Edition), Hamilton Depression Rating Scale (HAMD-17) and the following self-rated scales: Beck Depression Inventory (BDI), Beck Hopelessness Scale (BHS), Anxiety Sensitivity Index (ASI) and the Symptom Questionnaire (SQ) prior to starting the 26-week continuation phase. We defined 'EDs' as patients who dropped out either at or prior to Visit 2 (which was at 2 months into the 6-month continuation phase); those dropping out at Visit 3 or later were defined as 'LDs' (ED < or = 2 months and LD > 2 months). The Kruskal-Wallis and the Mann-Whitney U tests were used for data analysis. RESULTS: Of the 119 outpatients, 83 were completers (mean age: 42.1 +/- 9.0 years, 46 [55%] women, age of onset of major depressive disorder [MDD] = 24.3 +/- 12.5 years), 11 were EDs (mean age: 38.1 +/- 13.0 years, 4 [36%] women, age of onset of MDD = 22.0 +/- 11.1 years) and 25 were LDs (mean age: 35.2 +/- 10.4 years, 12 [48%] women, age of onset of MDD = 24.6 +/- 11.6 years). LDs were significantly younger than completers (P<.01). There was no significant difference in age between EDs and LDs, nor between EDs and completers. EDs and completers were depressed for a longer period of time compared to LDs (P<.05). EDs also had significantly greater overall impairment in social adjustment compared to completers (P<.05). CONCLUSIONS: Our data suggest that LDs are significantly younger than completers, although age is not a predictor between EDs and LDs. Further, EDs and completers are depressed for a longer duration than LDs, and EDs have significantly greater social impairment compared to completers. Our study identified some patient characteristics significantly associated with dropping out of a long-term clinical trial.

Adult↗

PubMed2002

Predictors of mood response to acute tryptophan depletion. A reanalysis.

Acute tryptophan depletion (ATD) induces depressive symptoms in 50-60% of selective serotonin reuptake inhibitor (SSRI) treated, recovered depressed patients. However, no reliable predictors of mood response to ATD have been established. In the present study, individual subject data of six ATD studies were pooled ('mega-analysis') in order to investigate the mediating role of clinical, demographic and biochemical characteristics in the mood response to ATD. A procedure was developed to make different versions of the Hamilton scale comparable. Recurrent depressive episodes, female gender, prior exposure to SSRI antidepressant treatment and previous serious suicidal thoughts/attempts all appear to be independent predictors of mood response to ATD. Chronicity of illness is the most powerful predictor. Residual symptoms of depression were not found to predict response to ATD. ATD may be useful to study the mechanism of action of SSRI antidepressants and individual biological vulnerability of the serotonin system. Whether the effects of ATD represent a reversal of the action of SSRI antidepressants or individual vulnerability probably depends upon the timing of the procedure in the course of remission of a depressive episode.

Adult↗

PubMed2002

Folinic acid (Leucovorin) as an adjunctive treatment for SSRI-refractory depression.

Low folate is associated with poorer response to selective serotonin reuptake inhibitors (SSRIs) in major depressive disorder (MDD). Folate supplementation in MDD has been studied in other settings with promising results. The objective of this study was to assess the efficacy of methylfolate as an adjunctive treatment among adults with MDD and inadequate response to an SSRI. Twenty-two adults (59% female; mean age 45.2 +/- 11.0 years) with DSM-IV MDD, partial or nonresponse to an SSRI after at least 4 weeks of treatment, and a 17-item Hamilton Depression Rating Scale (HAM-D-17) score > or = 12 were enrolled in this 8-week prospective open trial. Exclusion criteria included current use of anticonvulsants or psychotropics other than an SSRI, or B12 deficiency. Leucovorin (folinic acid), which is metabolized to methylfolate, was added to SSRIs at 15-30 mg/day. Folate levels rose from 28 +/- 19 ng/mL to 301 +/- 203 ng/mL (p < 0.001). HAM-D-17 scores among the 16 completers decreased from 19.1 +/- 3.9 to 12.8 +/- 7.0 (p < 0.01). However only 31% of completers and 27% of the intent-to-treat (ITT) sample achieved response (> or = 50% reduction in HAM-D-17 scores), and only 19% of completers and 18% of the ITT sample achieved remission (HAM-D-17 < or = 7). Leucovorin appears to be modestly effective as an adjunct among SSRI-refractory depressed individuals with normal folate levels. The application of leucovorin as an adjunct in the setting of refractory depression deserves further study.

Adult↗

PubMed2002

The pharmacologic management of SSRI-induced side effects: a survey of psychiatrists.

Despite the superior side effect profile of the newer antidepressants over the tricyclics and monoamine oxidase inhibitors, all newer antidepressants are associated with a wide array of side effects. Clinicians are constantly confronted with the challenge of managing these side effects in the context of minimal research to prove one management strategy is more effective than another. The purpose of this study was to examine prescribing practices regarding the management of SSRI-associated side effects in a sample of psychiatrists attending a psychopharmacology review course. A total of 439 out of 800 clinicians (55%) attending a psychopharmacology review course responded to our questionnaire that was given prior to beginning the review course, though not all respondents answered all four items on the questionnaire. Among these items were questions designed to assess clinician preference for the management of SSRI-induced side effects. As a treatment for SSRI-induced sexual dysfunction, 43% (143/330) chose adding bupropion, while 36% (120/330) opted to switch agents as their first choice; for SSRI-induced insomnia, 78% (264/326) chose adding trazodone. Switching agents was the first choice of 61% (214/353) of clinicians for managing SSRI-induced agitation, 93% (339/363) for managing SSRI-associated weight gain. In an effort to manage most SSRI-associated side effects (with the exception of sexual dysfunction and insomnia), the majority of the clinicians responding to our survey opted to switch agents rather than add a specific medication to the existing SSRI. In our opinion, this practice may reflect the relative lack of research studies on the role of adjunctive treatments in the management of SSRI-induced side effects and/or the tendency to favor monotherapy over polypharmacy.

Akathisia, Drug-Induced↗

PubMed2002

Role of S-adenosyl-L-methionine in the treatment of depression: a review of the evidence.

Major depression remains difficult to treat, despite the wide array of registered antidepressants available. In recent years there has been a surge in the popularity of natural or alternative medications. Despite this growing popularity, there is limited evidence for the effectiveness of many of these natural treatments. S-adenosyl-L-methionine (SAMe) is one of the better studied of the natural remedies. SAMe is a methyl donor and is involved in the synthesis of various neurotransmitters in the brain. Derived from the amino acid L-methionine through a metabolic pathway called the one-carbon cycle, SAMe has been postulated to have antidepressant properties. A small number of clinical trials with parenteral or oral SAMe have shown that, at doses of 200-1600 mg/d, SAMe is superior to placebo and is as effective as tricyclic antidepressants in alleviating depression, although some individuals may require higher doses. SAMe may have a faster onset of action than do conventional antidepressants and may potentiate the effect of tricyclic antidepressants. SAMe may also protect against the deleterious effects of Alzheimer disease. SAMe is well tolerated and relatively free of adverse effects, although some cases of mania have been reported in bipolar patients. Overall, SAMe appears to be safe and effective in the treatment of depression, but more research is needed to determine optimal doses. Head-to-head comparisons with newer antidepressants should help to clarify SAMe's place in the psychopharmacologic armamentarium.

Antidepressive Agents↗

PubMed2002

Acute efficacy of fluoxetine versus sertraline and paroxetine in major depressive disorder including effects of baseline insomnia.

This study assessed whether fluoxetine, sertraline, and paroxetine differ in efficacy and tolerability in depressed patients and the impact of baseline insomnia on outcomes. Patients (N = 284) with DSM-IV major depressive disorder were randomly assigned in a double-blind fashion to fluoxetine, paroxetine, or sertraline for 10 to 16 weeks of treatment. Using the Hamilton Rating Scale for Depression (HAM-D) sleep disturbance factor score, patients were categorized into low (<4) or high (>or=4) baseline insomnia subgroups. Changes in depression and insomnia were assessed. Safety assessments included treatment-emergent adverse events (AEs), reasons for discontinuation, and AEs leading to discontinuation. In addition, AEs were evaluated within insomnia subgroups to determine emergence of activation or sedation. Depression improvement, assessed with the HAM-D-17 total score, was similar among treatments in all patients (p = 0.365) and the high (p = 0.853) and low insomnia (p = 0.415) subgroups. Insomnia improvement, assessed with the HAM-D sleep disturbance factor score, was similar among treatments in all patients (p = 0.868) and in the high (p = 0.852) and low insomnia (p = 0.982) subgroups. Analyses revealed no significant differences between treatments in the percentages of patients with substantial worsening, any worsening, worsening at endpoint, or improvement at endpoint in the HAM-D sleep disturbance factor in either insomnia subgroup. Treatments were well tolerated in most patients. No significant differences between treatments in the incidence of AEs suggestive of activation or sedation were seen in the insomnia subgroups. These data show no significant differences in acute treatment efficacy and tolerability across fluoxetine, sertraline, and paroxetine in major depressive disorder patients. Improvement in overall depression and in associated insomnia was achieved by most patients regardless of baseline insomnia.

Acute Disease↗