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Maurizio Fava

Publications and source records attributed to Maurizio Fava.

At least 145 records · Page 8Linked to original sources

Double-blind study of high-dose fluoxetine versus lithium or desipramine augmentation of fluoxetine in partial responders and nonresponders to fluoxetine.

In a previous study, of 41 depressed patients who had not responded to fluoxetine 20 mg/day, 53% were treated with high-dose fluoxetine (40-60 mg/ day) and responded (i.e., their 17-item Hamilton Rating Scale for Depression [HAM-D-17] score was <7) versus 29% and 25% of patients treated with fluoxetine plus lithium (300-600 mg/day) or fluoxetine plus desipramine (25-50 mg/day), respectively. We wanted to assess whether these findings could be replicated in a larger sample of depressed outpatients. We identified 101 outpatients with major depressive disorder (52 men and 49 women; mean age, 41.6 + 10.6 years) who were either partial responders (n = 49) or nonresponders (n = 52) to 8 weeks of treatment with fluoxetine 20 mg/ day. These patients were randomized to 4 weeks of double-blind treatment with high-dose fluoxetine (40-60 mg/day), fluoxetine plus lithium (300-600 mg/day), or fluoxetine plus desipramine (25-50 mg/day). In the overall group of patients (N = 101), there was no significant difference in response rates across the three treatment groups (high-dose fluoxetine, 42.4%; fluoxetine plus desipramine, 29.4%; fluoxetine plus lithium, 23.5%). Dropout rates were also comparable, ranging from 9.1% (high-dose fluoxetine) to 14.7% (fluoxetine plus desipramine and fluoxetine plus lithium). There were also no significant differences in response rates across the three treatment groups among partial responders (high-dose fluoxetine, 50.0%; fluoxetine plus desipramine, 33.3%; fluoxetine plus lithium, 33.3%) and nonresponders (high-dose fluoxetine, 35.3%; fluoxetine plus desipramine, 26.3%; fluoxetine plus lithium, 12.5%). At the end of the study, the mean lithium level was 0.37 + 0.15 mEq/L (n = 27; range, 0.1-0.8 mEq/L) among lithium-treated patients, and the mean desipramine level was 104.7 + 58.8 ng/mL (n = 22; range, 25-257 ng/mL). There were no significant relationships between lithium or desipramine blood levels and degree of improvement (as measured by the change in HAM-D-17 score). We found no significant differences in efficacy among these three treatment strategies among patients who had failed to respond adequately to 8 weeks of treatment with fluoxetine 20 mg/day, although the high-fluoxetine group was associated with nonsignificantly higher response rates in both partial responders and nonresponders.

Adult↗

Effects of adding cognitive therapy to fluoxetine dose increase on risk of relapse and residual depressive symptoms in continuation treatment of major depressive disorder.

Patients with major depressive disorder remain at risk for relapse following remission and often continue to experience subthreshold symptoms. This study compared the rate of relapse of major depressive disorder and the prevalence of residual depressive symptoms during the continuation phase for patients treated with fluoxetine dose increase alone or in combination with cognitive therapy. A total of 132 outpatients with major depressive disorder who achieved remission with 8 weeks of treatment with fluoxetine 20 mg had the dose increased to 40 mg. They were randomized to receive cognitive therapy or medication management alone and were followed for up to 28 weeks for depressive relapse and change in depressive symptoms. A total of 47 (35.6%) out of 132 patients did not complete the 28-week continuation phase. Rates of discontinuation or relapse did not differ significantly between the groups. Change in residual symptoms or wellbeing as measured by Hamilton Depression Scale score or Symptom Questionnaire self-report also did not differ between groups. In this sample of outpatients in continuation phase treatment for major depressive disorder, the combination of cognitive therapy and fluoxetine 40 mg failed to yield any significant benefit in symptoms or relapse rates over fluoxetine 40 mg alone during 28 weeks of follow-up.

Adult↗

Use of the Chinese version of the Beck Depression Inventory for screening depression in primary care.

Many Asian-Americans are unfamiliar with depression and its treatment. When depressed, they generally seek treatment from their primary care physicians and complain about their physical symptoms, resulting in under-recognition and under-treatment of depression. This study evaluates the effectiveness of the Chinese version of the Beck Depression Inventory (CBDI) for screening depression among Chinese-Americans in primary care. A total of 503 Chinese-Americans in the primary care clinic of a community health center were administered the CBDI for depression screening. Patients who screened positive (CBDI > or = 16) were interviewed by a psychiatrist using the Structured Clinical Interview for DSM-III-R, patient version (SCID-I/P) for confirmation of the diagnosis. Patients who screened negative (CBDI < 16) were randomly selected to be interviewed using the depression module of the SCID-I/P. The results of the SCID-I/P interview were used as the standard for evaluating the sensitivity and specificity of the CBDI. A total of 815 Chinese-Americans in a primary care clinic were approached, and 503 completed the CBDI. Seventy-six (15%) screened positive (CBDI > or = 16), and the prevalence of major depression was 19.6% by using extrapolated results from SCID-I/P interviews. When administered by a native-speaking research assistant, the CBDI has good sensitivity (.79), specificity (.91), positive predictive value (.79), and negative predictive value (.91). Despite the commonly believed tendency to focus on physical symptoms rather than depressed mood, Chinese-Americans are able to report symptoms of depression in response to a questionnaire. The CBDI, when administered by research assistants, has good sensitivity and specificity in recognizing major depression in this population. Lack of interest among Chinese-American patients in using the CBDI as a self-rating instrument has limited its use for depression screening in primary care settings.

Adolescent↗

Predictors of stable personality disorder diagnoses in outpatients with remitted depression.

This study examined the stability of comorbid personality disorder diagnoses once an outpatient's depression remitted. The sample consisted of 75 outpatients who responded to treatment in an 8-week acute treatment phase for depression, who met criteria for remission throughout a 26-week continuation phase, and who completed a personality assessment (Structured Clinical Interview for DSM-III-R-axis II Disorders) at the beginning and at the end of each treatment phase. The authors found that after a major depressive disorder is successfully treated, personality disorder diagnoses remain stable across time during continuation treatment. Gender was the only potential predictor variable that was significant: the proportion of men who had a stable personality disorder diagnosis in cluster A or cluster B was significantly greater than the proportion of women who had a stable personality disorder diagnosis in these two clusters. Among women, those with any stable personality disorder had a significantly longer duration of the current major depressive disorder compared with those who never met criteria for any personality disorder; this was also true for women with a cluster C personality disorder diagnosis.

Adult↗

Fluoxetine treatment of depressed patients with comorbid anxiety disorders.

Major depression with comorbid anxiety disorder is associated with poor antidepressant outcome compared to major depression without comorbid anxiety disorder. The purpose of our study was to assess changes in severity of both depressive and anxiety symptoms in outpatients with major depression with comorbid anxiety disorder following fluoxetine treatment. We enrolled 123 outpatients (mean age 38.9 +/- 10.8 years; 49% women) with major depressive disorder accompanied by one or more current comorbid anxiety disorders in our study. Patients were treated openly with fluoxetine 20 mg/day for 8 weeks. Efficacy assessments included the 17-item Hamilton Rating Scale for Depression (HAM-D) and the patient-rated Symptom Questionnaire (SQ) Scales for Depression and Anxiety. The mood and anxiety disorder modules of the Structured Clinical Interview for DSM-III-R were administered at screen and endpoint. We used 'intent-to-treat' analysis in examining all patients assigned to treatment and completing the baseline visit. The mean number of comorbid anxiety disorders per patient was 1.5 +/- 0.68. The mean HAM-D-17 score and mean Clinical Global Impressions-Severity scores decreased significantly from baseline to endpoint (week 8) following fluoxetine treatment (p < 0.0001). There were significant decreases in all four SQ scale scores, from baseline to endpoint: depression, anxiety, somatic symptoms and anger-hostility (p < 0.0001). Fifty-three percent of patients (n = 65) were depression responders (i.e. > or = 50% decrease in HAM-D-17 score at endpoint) and 46% (n = 57) were remitters (HAM-D-17 < or = 7 at endpoint). Patients with panic disorder had significantly higher baseline HAM-D-17 scores compared to those without panic disorder (p < 0.01). Patients with comorbid obsessive-compulsive disorder (OCD) were significantly less likely to be responders to fluoxetine at endpoint (> or = 50% decrease in HAM-D-17) and to be remitters (HAM-D-17 score of s 7 at endpoint) compared to patients without comorbid OCD (p < 0.01). Of the 41 patients on whom endpoint Structured Clinical Interview for DSM-III-R modules for anxiety disorders were available, 49% (n = 20) no longer met criteria for one or more of their anxiety disorder diagnoses at endpoint. Our preliminary findings suggest that fluoxetine is effective in treating outpatients with major depression with comorbid anxiety disorders, with a significant effect on both depression and anxiety symptoms. Further double-blind, placebo-controlled trials are required in larger samples to confirm our findings.

Adult↗

An open study of olanzapine and fluoxetine for psychotic major depressive disorder: interim analyses.

BACKGROUND: Although atypical antipsychotic agents are commonly used in the treatment of psychotic depression, there are no published prospective studies on their use in this condition. The aim of this study was to assess, by interim analyses, the efficacy of the atypical antipsychotic agent olanzapine in combination with the selective serotonin reuptake inhibitor antidepressant agent fluoxetine. METHOD: We enrolled 27 patients (17 women [63.0%] and 10 men [37.0%]; mean +/- SD age: 41.2 +/- 14.7 years) with DSM-IV-defined major depressive disorder with psychotic features into an open trial of olanzapine, 5 to 20 mg/day, plus fluoxetine, 20 to 80 mg/day. Patients were assessed at each visit with the 17-item Hamilton Rating Scale for Depression and both the psychotic and mood modules of the Structured Clinical Interview for DSM-IV Axis I Disorders, Patient Edition. We are reporting the results of the first 6 weeks of treatment. RESULTS: Twenty-two (81.5%) of the 27 enrolled patients completed the 6-week open trial, and 5 (18.5%) dropped out, with only 2 (7.4%) dropping out due to side effects. Of the 27 patients, 74.1% (N = 20) met criteria for melancholic features, 14.8% (N = 4) had delusions alone, 18.5% (N = 5) had hallucinations alone, and 66.7% (N = 18) reported both delusions and hallucinations. In addition, the overall rates of response for the intent-to-treat group were as follows: depression response rate, 66.7% (N = 18); psychosis response rate, 59.3% (N = 16); psychotic depression response rate, 55.6% (N = 15); and psychotic depression remission rate, 40.7% (N = 11). CONCLUSION: The combination of olanzapine and fluoxetine appears to be a promising, safe, and effective treatment for psychotic depression. Double-blind studies are needed to confirm this impression.

Adolescent↗

Sexual functioning and SSRIs.

This article reviews the literature concerning the relationship between sexual functioning and selective serotonin reuptake inhibitors (SSRIs). Reduced sexual functioning is a common depressive symptom that typically improves after successful antidepressant treatment. On the other hand, sexual dysfunction has been observed in a substantial proportion of patients treated with all classes of antidepressants. In particular, SSRI use has been shown to be associated with sexual dysfunction. A number of pharmacologic interventions have been found to be helpful in anecdotal case reports. Unfortunately, the lack of placebo-controlled studies in this area limits our ability to draw firm conclusions on the efficacy of such interventions. Three classes of drugs have primarily been used to counteract sexual side effects of SSRIs: serotonin receptor antagonists, a2-adrenergic receptor antagonists, and dopaminergic agents. An open trial from our group suggests the potential usefulness of oral sildenafil in the treatment of antidepressant-associated sexual side effects, but further studies are needed.

Adrenergic alpha-Antagonists↗

Relationships between major depressive disorder and comorbid anxiety and personality disorders.

OBJECTIVE: The aim of the study was to examine whether comorbid anxiety disorders influence depressed patients' likelihood of meeting criteria for a personality disorder (PD) and whether comorbid anxiety disorders influence the stability of the PDs in patients with remitted depression. METHODS: The initial sample consisted of 373 outpatients who met criteria for major depressive disorder (MDD) (by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition-Patient Edition) and who were enrolled in the 8-week acute treatment phase of a study of fluoxetine for MDD. Sixty-four subjects who responded to fluoxetine treatment in the acute phase met criteria for remission throughout a 26-week continuation phase during which they remained on fluoxetine with or without cognitive behavioral therapy. Stability of PDs was defined as meeting criteria for a PD at both beginning and end point of the continuation treatment phase. RESULTS: Before fluoxetine treatment, anxious depressed patients (defined as meeting criteria for MDD as well as at least one comorbid anxiety disorder) were significantly more likely to meet criteria for any comorbid PD diagnosis compared with depressed patients without comorbid anxiety disorders. In particular, there was a significant relationship between the presence of Cluster A and C PDs and the presence of anxious depression at baseline before antidepressant treatment. After successful treatment of MDD, we found a significant relationship between anxious depression diagnosed at baseline and the stability of a Cluster C PD diagnosis. CONCLUSION: Anxious depression may place patients at greater risk of having a PD diagnosis, especially one from Cluster A or C. Once the depression remits, patients who initially met criteria for anxious depression may be more likely to maintain a Cluster C PD diagnosis compared with patients initially diagnosed with MDD alone.

Adult↗

Quality of life assessments in major depressive disorder: a review of the literature.

According to the DSM-IV classification, a diagnosis of Major Depressive Disorder (MDD) is possible only when there is evidence of significant inference with functioning. However, despite the high prevalence of MDD in the general population, it is uncommon for clinicians to assess overall functioning in a systematic way before making such diagnosis. An important correlate of functioning is quality of life, which is typically defined as "patients' own assessments of how they feel about what they have, how they are functioning, and their ability to derive pleasure from their life activities". In the present article, we review studies focusing on the relationship between depression and quality of life, particularly focusing on the impact of the treatment of depression on quality of life. Studies focusing on the quality of life in MDD are reviewed. Candidate studies published between 1970 and recently were initially identified by Pubmed and Ovid search cross-referencing the terms "quality of life," "psychosocial functioning" with "major depression" and "treatment." A number of studies report poorer quality of life in MDD patients compared to controls. Several studies also report an improvement in quality of life measures during various phases of treatment with antidepressants and/or psychotherapy. However, trials comparing the role of newer psychopharmacologic agents in the acute phase of treatment, and the role of newer psychotherapies in the continuation and maintenance phases of treatment in restoring psychosocial functioning and improving the quality of life in MDD are lacking. Exploring the impact of these modalities on psychosocial function and quality of life in MDD are necessary to help translate clinical response into restoration of psychosocial function and to thus further improve the standard of care.

Major Depressive Disorder↗

Prevalence of major depressive disorder among Chinese-Americans in primary care.

An epidemiological study in Los Angeles showed that Chinese Americans had lower rates of depression compared to the U.S. national estimates. This study surveys the prevalence of major depressive disorder (MDD) among Asian-Americans in the primary care setting. A two-phase epidemiological survey was performed in the primary care clinic of a community health center in Boston, MA, which provides treatment to under-served Asian-Americans. Participants were Chinese Americans in the waiting area of the primary care clinic, 18 years of age or older, who spoke any one the four commonly used Chinese dialects. The Chinese version of the Beck Depression Inventory (CBDI) was used for initial screening. All consenting patients who screened positive (CBDI >/= 16) and a fraction of those who screened negative (CBDI < 16) were interviewed by a bilingual and bicultural psychiatrist with the Structured Clinical Interview for DSM-III-R, patient version, for confirmation of the diagnosis of MDD. There were 815 in the primary care clinic that were approached, of which 503 patients (62% female, mean age 50 +/- 17 years) filled out the CBDI in the initial phase of depression screening. Extrapolating the results from the SCID-P interviews, the prevalence of MDD among Asian-Americans in the primary care setting was estimated to be 19.6% +/- 0.06. MDD is common among Asian-Americans in primary care settings. The prevalence of MDD is comparable to or higher than those found in the U.S. nonminority populations.

Adolescent↗

Integrating psychiatry and primary care improves acceptability to mental health services among Chinese Americans.

The objective of this study was to investigate whether integrating psychiatry and primary healthcare improves referral to and treatment acceptability of mental health services among Chinese Americans. The "Bridge Project," a program to enhance collaboration between primary care and mental health services for low-income Chinese immigrants was implemented at South Cove Community Health Center in Boston. The project consisted of conducting training seminars to primary care physicians to enhance recognition of common mental disorders, using a primary care nurse as the "bridge" to facilitate referrals to the Behavioral Health Department of the same facility, and co-locating a psychiatrist in the primary care clinic to provide onsite evaluation and treatment. The rate of mental health service referrals and successful treatment engagement before and during the project were compared. During the 12-month period of the Bridge Project, primary care physicians referred 64 (1.05% of all clinic patients) patients to mental health services, a 60% increase (chi(2)=4.97, P<.05) in the percentage of clinic patients referred in the previous 12 months. Eighty-eight percent of patients referred during the project showed up for psychiatric evaluation, compared to 53% (chi(2)=15.3, P<.001) in the previous 12 months. Integrating psychiatry and primary care is effective in improving access to mental health services and in increasing treatment engagement among low-income immigrant Chinese Americans.

China↗

Clinical features of depressed outpatients with and without co-occurring general medical conditions in STAR*D.

BACKGROUND: A significant percentage of patients with major depressive disorder (MDD) suffer from concurrent general medical conditions (GMCs). OBJECTIVE: The objective of this preliminary report was to describe the rates of co-occurring significant GMCs and the clinical correlates and symptom features associated with the presence of GMCs. DESIGN: Baseline cross-sectional case-control study of patients enrolling in a prospective randomized multistage treatment study of MDD. SETTING: Fourteen regional U.S. centers representing 19 primary care and 22 psychiatric practices. PATIENTS: One thousand five hundred outpatients with DSM-IV nonpsychotic MDD. MEASUREMENTS: Sociodemographic status, medical illness ratings, psychiatric status, quality of life and DSM-IV depression symptom ratings. RESULTS: The prevalence of significant medical comorbidity in this population was 52.8% (95% CI 50.3-55.3%). Concurrent significant medical comorbidity was associated with older age, lower income, unemployment, limited education, longer duration of index depressive episode and absence of self-reported family history of depression. Somatic symptoms common in MDD were endorsed at a higher rate in those with GMCs. Those without a GMC had higher rates of endorsement of impaired mood reactivity, distinct mood quality and interpersonal sensitivity. CONCLUSIONS: Concurrent GMCs are common among outpatients with MDD in both primary care and specialty settings. Concurrent GMCs appear to influence the severity and symptom patterns in MDD and describe a vulnerable population with sociodemographic challenges to effective assessment and treatment.

Adolescent↗

Methods of testing feasibility for sequenced treatment alternatives to relieve depression (STAR*D).

In large multi-site trials, a feasibility or pilot study can be crucial to test the functionality of all aspects of conducting the study prior to the initiation of the formal study. A feasibility trial was conducted for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Project, a multi-site, prospective, sequentially randomized, clinical trial of outpatients with nonpsychotic major depressive disorder. From 14 December 2000 to 8 June 2001, 42 patients were screened for enrollment into the STAR*D Feasibility Trial. Twenty-four patients who were eligible and consented to participate were treated with citalopram for up to 12 weeks. During the course of this trial, issues were raised that resulted in modifications to the study procedures. Modifications made as a result of this trial affected four domains: (1) communication, (2) patient and provider burden, (3) data collection forms, and (4) recruitment and retention of subjects. This paper describes what was learned during the STAR*D Feasibility Trial so researchers planning to conduct similar trials can learn the practical issues related to conducting such a research project. While the information gathered was useful, it did delay the initiation of the formal trial. We view this cost as an investment in the development of overall study procedures that should lead to a stronger study.

Clinical Trials as Topic↗

Suicide risk management for the sequenced treatment alternatives to relieve depression study: applied NIMH guidelines.

NIMH guidelines to manage subjects who are suicidal during their participation in clinical trials include a full range of procedures to minimize suicidal risk, yet no reports to date have shown how researchers should best implement these guidelines. The architects of the sequenced treatment alternatives to relieve depression (STAR*D) study operationalized and implemented the NIMH guidelines by developing a comprehensive set of procedures to detect, monitor, and manage suicidal subjects during a large, complex, multisite clinical trial. Because of the large size of the study (anticipated n = 4000), the wide geographic distribution, the large number of treating STAR*D clinicians, the broad array of subjects with psychiatric and medical comorbidities, and the focus on treatment-resistant depression, along with the complexity of multiple treatment steps and randomization points in STAR*D, the risk of suicide, safety monitoring of suicidal subjects presented a unique challenge. This paper describes methods derived from the NIMH guidelines used to manage suicidal risk in STAR*D including the use of an interactive voice response system to alert clinicians, regional center directors, and safety officers.

Clinical Trials as Topic↗

Comparing anxiety disorders and anxiety-related traits in bipolar disorder and unipolar depression.

The frequent comorbidity of anxiety disorders and mood disorders has been documented in previous studies. However, it remains unclear whether specific anxiety traits or disorders are more closely associated with unipolar major depression (MDD) or bipolar disorder (BPD). We sought to examine whether MDD and BPD can be distinguished by their association with specific types of anxiety comorbidity. Individuals with a primary lifetime diagnosis of either bipolar disorder (N=122) or major depressive disorder (N=114) received diagnostic assessments of anxiety disorder comorbidity, and completed questionnaires assessing anxiety sensitivity and neuroticism. The differential association of these anxiety phenotypes with MDD versus BPD was examined with multivariate modeling. Panic disorder and generalized anxiety disorder (GAD) specifically emerged amongst all the anxiety disorders as significantly more common in patients with BPD than MDD. After controlling for current mood state, anxiety sensitivity and neuroticism did not differ by mood disorder type. This study supports prior research suggesting a specific panic disorder-bipolar disorder connection, and suggests GAD may also be differentially associated with BPD. Further research is needed to clarify the etiologic basis of anxiety disorder/BPD comorbidity and to optimize treatment strategies for patients with these co-occurring disorders.

Adult↗

Treatment-related adverse events and outcome in a clinical trial of fluoxetine for major depressive disorder.

Treatment-related adverse events (TRAEs), particularly those that occur early on, may increase the likelihood for premature discontinuation of antidepressants. The purpose of this study was to examine the relationship between TRAEs and outcome in depressed outpatients enrolled in an 8-week, 20 mg, open trial of fluoxetine. A total of 384 patients (54.7% women, mean age 39.9 +/- 10.5 years) were enrolled in the trial. Study visits occurred at baseline and every other week. Somatic complaints were assessed during each study visit. Somatic complaints that, in the opinion of the evaluating physician, were probably related or related to treatment with fluoxetine were entered in the analysis as TRAEs. We then tested whether 1) developing at least one TRAE, 2) developing at least one moderate or severe TRAE, 3) the number of TRAEs reported during the entire trial, or 4) the number of TRAEs reported during each 2-week interval predicted whether patients would respond to fluoxetine, or prematurely discontinue treatment. None of the above scores predicted whether patients responded to or prematurely discontinued the trial. These findings failed to reveal any relationship between side effects and treatment outcome for patients with MDD enrolled in an 8-week, 20 mg, fixed dose, open trial of fluoxetine.

Adolescent↗

Melancholia and axis II comorbidity.

This study assessed whether the rates of comorbid personality disorders differed between DSM-IV melancholic and nonmelancholic major depressive disorder. We evaluated 260 consecutive depressed outpatients (140 women [53.8%]; mean age, 39.01 +/- 10.4 years) with DSM-III-R major depressive disorder (MDD). MDD was diagnosed with the use of the Structured Clinical Interview for DSM-III-R-Patient Edition (SCID-P); enrolled patients were required to have a score >/= 16 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17). The presence of the melancholic subtype of major depression was determined with the use of a DSM-IV checklist, while the presence of personality disorders was assessed using the Structured Clinical Interview for DSM-III-R-Personality Disorders (SCID-II). Of the 102 (39.2%) patients who met criteria for melancholic depression and the 158 (60.7%) who did not, there were no significant differences in age, gender, or rates of personality disorder diagnoses. We observed no significant difference in rates of individual personality disorder clusters between melancholic and nonmelancholic depressed patients. Our findings of comparable rates of comorbid personality disorders between melancholic and nonmelancholic depression are consistent with the decision made by the DSM-IV task force to drop the DSM-III-R melancholic feature criterion of "no significant personality disturbance before first major depressive episode" as they challenge the usefulness of trying to establish such absence of premorbid personality features in acutely depressed patients.

Adolescent↗