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Biomedical subjects

I Gilaberte

Publications and source records attributed to I Gilaberte.

17 recordsLinked to original sources
PubMed2001

Use of olanzapine in dysphoric mania.

BACKGROUND: The simultaneous presentation of both manic and depressive symptoms has long been recognized. Nevertheless, a variable prevalence of dysphoric mania has been reported. The aim of this study was to estimate the prevalence of dysphoric mania among hospitalized patients and to assess the effectiveness of olanzapine in this type of patients. METHODS: Eighty-six patients who met DSM-IV criteria for mania were evaluated at admission with a protocol that included McElroy's criteria for dysphoric mania [Am. J. Psychiatry 149 (1992) 1633]. Treatment was administered according to clinical need, using mood stabilizers combined with antipsychotics. Sequential assessments were conducted throughout the study. RESULTS: Forty-four patients (51.2%) fulfilled McElroy's criteria for dysphoric mania. Fourteen of these dysphoric patients were treated with olanzapine in combination with mood-stabilizers. All patients improved in manic symptoms but patients treated with olanzapine improved significantly more than those treated with other antipsychotics in depressive symptoms. LIMITATIONS: The lack of randomization is a methodological limitation of this study, so these findings should be considered as preliminary. CONCLUSIONS: Dysphoric symptoms are common in this population of manic patients. Olanzapine in combination with mood-stabilizers may be effective in these patients. Additional controlled studies are needed to replicate these results.

Adult↗
PubMed2001

Augmentation of fluoxetine's antidepressant action by pindolol: analysis of clinical, pharmacokinetic, and methodologic factors.

In a controlled trial, the beta-adrenoceptor/5-hydroxytryptamine-1A (5-HT1A) receptor antagonist pindolol accelerated and enhanced the antidepressant effect of fluoxetine. The median times to sustained response (> or = 50% reduction of baseline severity maintained until endpoint) were 19 days for fluoxetine plus pindolol (N = 55) and 29 days for fluoxetine plus placebo (N = 56) (p = 0.01). The response rate at endpoint was 16% greater in patients treated with the combination. The plasma concentration of pindolol remained stable between 3 days (first blood sampling) and 6 weeks. Mean values were approximately 26 nM, a concentration higher than the Ki of (-)pindolol for human 5-HT1A autoreceptors (11 nM). Plasma fluoxetine and norfluoxetine concentrations increased steadily until the fourth week of treatment. Fluoxetine concentrations were lower in patients receiving the combination (p = 0.043), but there was no significant relationship to the clinical response in either group. A reanalysis of the data using a survival analysis revealed that significant differences in the time to sustained response between both groups would have also been detected (1) in a 2-week trial, (2) without a placebo lead-in phase, and (3) with less frequent visits. However, the use of "response" instead of "sustained response" as measure of clinically relevant change would have greatly diminished the difference between treatment arms (p = 0.08 instead of p = 0.01). This emphasizes the need of using stringent outcome criteria in antidepressant drug trials. A comparison of the data of all sustained responders (N = 27) in the fluoxetine-plus-placebo group with the first 27 responders in the fluoxetine-plus-pindolol group (of a total of 38) revealed a highly significant difference in the time to sustained response (18 and 10 days, respectively; p = 0.0002). This indicates that the faster response in the fluoxetine-plus-pindolol group is not a result of the greater proportion of responders.

Adrenergic beta-Antagonists↗
PubMed2001

Fluoxetine in the prevention of depressive recurrences: a double-blind study.

Optimal outcomes from depression treatment are long-term recovery and, in the case of recurrent depression, prevention of new episodes. However, few data are available concerning the long-term efficacy of antidepressants in prophylactic treatment to prevent recurrences of depression. The efficacy and safety of fluoxetine 20 mg/day was evaluated in reducing the number of depressive episodes and in extending the time free of symptoms in patients with recurrent unipolar major depression. Patients with recurrent unipolar major depression according to DSM-III-R criteria and who responded to 32 weeks of open-label fluoxetine were randomly assigned to receive fluoxetine 20 mg/day (N = 70) or placebo (N = 70) for 48 weeks of double-blind maintenance treatment. Outcome measures were the percentage of recurrences and time to recurrence. Safety assessments included treatment-emergent adverse events, reasons for discontinuation, vital signs, and laboratory measures. Fluoxetine was associated with a statistically significantly smaller percentage of patients who had a recurrence compared with placebo (20% vs. 40%; chi2 analysis, p = 0.010). The symptom-free period was significantly longer for patients treated with fluoxetine versus placebo (295 vs. 192 days; Kaplan-Meier estimates, log-rank test, p = 0.002). Treatments were well tolerated during maintenance treatment. The only statistically significant difference in adverse events between treatment groups was anxiety, which was more frequent in the placebo group (fluoxetine, 12.9% vs. placebo, 30%; chi2 analysis, p = 0.013). Two placebo-treated patients and no fluoxetine-treated patients were withdrawn because of adverse events. In conclusion, fluoxetine at 20 mg/day was effective and well tolerated for the prophylactic treatment of recurrent unipolar major depression.

Adolescent↗
PubMed2001

Olanzapine as long-term adjunctive therapy in treatment-resistant bipolar disorder.

The aim of this study was to estimate the long-term effectiveness of olanzapine as adjunctive therapy in patients with bipolar disorder who exhibited an inadequate response to mood stabilizers. Twenty-three Research Diagnostic Criteria (RDC) patients with bipolar I and II were assessed by means of the Schedule for Affective Disorders and Schizophrenia and entered if they gave their consent to participate. All of them had experienced frequent relapses, residual subsyndromal symptoms, and inadequate responses to other drugs, such as lithium, valproate, or carbamazepine. While maintaining other drugs, they all received open-label, increasing doses of olanzapine, until achieving clinical response. Other drugs were maintained. The patients were assessed several consecutive times from baseline to the endpoint with the Clinical Global Impressions (CGI) scale for use in bipolar illness. Records of recurrences, hospitalizations, and side effects were also collected. The last-observation-carried-forward analysis showed that there was a significant reduction of CGI scores after the introduction of olanzapine, either in manic symptoms (p = 0.0015), depressive symptoms (p = 0.0063), or global symptoms (p = 0.0003). The most frequent adverse events were somnolence (17%) and weight gain (13%). The mean dose of olanzapine at the end of the 43-week follow-up was 8.1 mg/day. Olanzapine may be a useful medication for the long-term adjunctive treatment of patients with bipolar disorder who exhibit a poor response to mood stabilizers, such as lithium, valproate, or carbamazepine. These results suggest mood-stablizing properties of olanzapine.

Adult↗
PubMed2000

Cost-effectiveness of fluoxetine plus pindolol in patients with major depressive disorder: results from a randomized, double-blind clinical trial.

Some preliminary studies have suggested that the beta-adrenoceptor 5-HT1A antagonist pindolol (PIN) could increase the effect of selective serotonin reuptake inhibitors (SSRIs). We prospectively estimated the cost-effectiveness of fluoxetine and pindolol versus fluoxetine plus placebo, using results from the first double-blind randomized clinical trial comparing both treatments. Efficacy and medical care resource utilization were collected prospectively in a parallel, randomized, double-blind clinical trial conducted in a single centre in Spain. Average cost-effectiveness (cost/% response and cost/% remission) as well as the incremental cost-effectiveness were calculated for both treatments. A 'bootstrap' method was used to calculate confidence limits around the incremental cost-effectiveness ratio. A significantly greater percentage of patients (one-tailed P < 0.05) in the fluoxetine FLX + PIN group than in the FLX + PLA group had experienced a therapeutic response (74.5% versus 58.97%) at 6 weeks. Direct medical costs were lower in the FLX + PIN group (mean 2508 pesetas per patient) than in the FLX + PLA group (mean 31870 pesetas per patient). Hospital admissions due to worsening of depressive symptoms were significantly lower (P < 0.05) in the FLX + PIN group (0/55) than in the FLX + PLA group (4/56). The observed differences in average costs and percentage response in the study were -29362 pesetas (< 0) and 15.6% (> 0), respectively, and the resulting cost-effectiveness ratio was negative. These outcomes indicate that the FLX + PIN option completely dominates FLX + PLA. These results suggest that, over a course of 6 weeks of treatment, the combination of fluoxetine and pindolol incurs lower direct medical costs than treatment with fluoxetine placebo. Despite their limitations, economic assessments in addition to clinical trials allow a 'dynamic assessment' on the potential success of the drug, both from a clinical and an economic point of view, allowing decisions on priorities to be made earlier.

Adult↗
PubMed1999

[The costs of treatment with the new antidepressants in clinical practice].

OBJECTIVE: To assess if, in usual clinical practice, the patterns of use of new antidepressant are associated to different health resource utilisation. DESIGN: Naturalistic, retrospective, observational study. SETTING: Urban health center. PATIENTS: DSM-IIIR diagnostic criteria of depressive disorder and treatment with a new antidepressant (n = 328). INTERVENTIONS: Information on resource utilisation was collected in those patients treated with fluoxetine (FLX), fluvoxamine (FLV) sertraline (SER), paroxetine (PAR) and venlafaxine (VLF). Direct, indirect and total costs were compared according to the different patterns of use (stable therapy, upward dose titration, switching or augmentation) and according to the initially prescribed antidepressant. The follow-up period was 6 months. RESULTS: Direct and total daily costs of those patients with unestable therapy (upward dose titration, switching or augmentation) were 55% (p < 0.01) and 87% (p = 0.001) higher than for patients with stable therapy, respectively. Patients who initiated therapy on SER, VLF and PAR had 35% (p < 0.05), 80% (p < 0.05) and 37% (p < 0.05), respectively, higher average total costs per day than patients who initiated therapy with FLX. Regarding direct costs, patients who initiated therapy on SER and VLF had 48% (p < 0.001) and 58% (p < 0.05) higher average costs per day than patients who initiated therapy with FLX. CONCLUSIONS: New antidepressants show different patterns of use in a clinical practice setting, being FLX the agent more associated to a stable pattern of use. The pattern of use is associated to different health resource utilisation. Patients under stable therapy show lower health costs than those who need upward titration, switching or augmentation strategies. It is necessary to conduct randomized naturalistic studies to confirm these results.

Adult↗
PubMed1997

Randomised, double-blind, placebo-controlled trial of pindolol in combination with fluoxetine antidepressant treatment.

BACKGROUND: Major depression affects more than 5% of the population and is a serious health and economic problem. Antidepressants have a slow onset of action and are effective in less than two-thirds of patients. The biochemical effects of selective serotonin reuptake inhibitors may be limited by the negative feedback from serotonin autoreceptors. Pindolol is an antagonist of both serotonin autoreceptors and beta-adrenoceptors. We studied the effect of the addition of pindolol to fluoxetine antidepressant treatment. METHODS: Of 132 eligible patients with major depression, 111 were randomly assigned to treatment with fluoxetine (20 mg daily) and either placebo or pindolol (7.5 mg daily). Patients were assessed twice a week for the first 3 weeks of active treatment and then once a week until the end of the study (42 days). Hamilton and Montgomery-Asberg depression-rating scales were used to assess depression severity. FINDINGS: The proportion of patients who responded to treatment with fluoxetine and pindolol was greater than that with fluoxetine and placebo (41/55 [75%] vs 33/56 [59%], [90% CI 1.1-30.1], p = 0.04). The proportion of patients who achieved a sustained response was also greater in the fluoxetine and pindolol group than in the fluoxetine and placebo group (38/55 [69%] vs 27/56 [48%] [5.9-35.9], p = 0.03). The number of days to reach a sustained response was lower in the fluoxetine and pindolol group than in the fluoxetine and placebo group (median 19 vs 29 days, p = 0.01), however, there was no difference in the time-to-onset of clinical improvement when stringent conditions were used (15 vs 18 days, p = 0.20). INTERPRETATION: The addition of pindolol to fluoxetine antidepressant treatment increases the effectiveness of fluoxetine therapy. Further work is needed to resolve whether the time to clinical improvement benefits from this combination and whether the increase in efficacy occurs with other antidepressants.

Adult↗
PubMedDate not supplied

SSRI antidepressant use patterns and their relation to clinical global impression scores: a naturalistic study.

BACKGROUND: A cascade of events follows initial antidepressant selection which includes the subsequent antidepressant use pattern, resultant clinical outcomes, and associated health care expenditures. PURPOSE: The purpose of this study using data from a clinical practice setting was to test whether the pattern of antidepressant use was correlated with patients' treatment response as measured by the score on the Clinical Global Impression-Improvement scale. DATA AND METHODS: A retrospective dataset of patients who initiated therapy on fluoxetine, fluvoxamine, paroxetine, or sertraline in a primary care setting in Spain was used. A Cox proportional hazard analysis was used to predict the likelihood of treatment response based upon the pattern of initial antidepressant use, while minimizing the influence of other factors. RESULTS: After controlling for other observed baseline characteristics including initial disease severity, (a) patients who remained on their initial antidepressant therapy for at least 2 months with no switching, augmentation, or upward dose titration were 1.63 times more likely to experience a treatment response than patients who had an adjustment to therapy; and (b) patients who initiated therapy on sertraline were 0.46 times as likely to experience a treatment response as patients who initiated therapy on the most common study antidepressant, fluoxetine. CONCLUSION: The pattern of antidepressant use is an important determinant of treatment response among patients initiating therapy on the newer antidepressants in clinical practice.

Adult↗
PubMedDate not supplied

[Subsyndromal depressive semiology in severe alcoholism].

INTRODUCTION: Several investigations have communicated frequent association between alcohol dependence and depression. METHOD: 21 subjects with DSM-IV criteria for alcohol dependence were included in an open label trial for alcohol withdrawal. At inclusion and along the follow-up none of the probands met DSM-IV criteria for mood disorder. Follow-up included a 15-day detoxification period and 195 days of withdrawal program, including treatment with 20 mg/d of fluoxetine. Occurrence of depressive semiology was measured using the Beck Depression Inventory (BDI) on day 15 (after detoxification), day 75 and day 210 (after withdrawal from ethanol of 195 days). RESULTS: 67% of the sample showed a positive basal BDI (after-detoxification-BDI> 9). Global retention rate after 210 days of follow-up was 57%. All patients who dropped out the investigation before completing the protocol showed a basal BDI in the depressive rank (BDI= 10-63), and maintained depressive scores in this instrument until their abandonment. CONCLUSIONS: Prevalence of < > in this population appears to be high. This clinical feature is frequently ignored because most of the patients do not meet standardized diagnostic criteria for mood disorders. Post-detoxification BDI could be used as a predictive factor of therapeutic result in long-term alcohol withdrawal programs. In addition, in our study fluoxetine showed efficacy in maintaining long-term alcohol abstinence.

Adolescent↗
PubMedDate not supplied

[Open study of fluoxetine in children with autism].

INTRODUCTION: Serotonergic dysfunction have been implicated in the pathophysiology of the autism. SRIs have shown efficacy in improving some symptoms in children with Autism. OBJECTIVES: To evaluate, in a pilot study, the efficacy and safety of fluoxetine in very young children with autism. METHOD: 1 year open-label trial was made with fluoxetine on 12 patients (3 to 13 years old) with Pervasive Developmental Disorder. CGI-severity was used to assess the severity and the improvement of symptoms. Individual symptoms improvement was assessed by both parents and therapists. Fluoxetine dose was titrated in all patients from 1.2 ml/day to reach a final doses of 3,6 or 5 ml/day in four weeks. Tolerance was assessed by collecting spontaneous adverse events. RESULTS: 11 children completed the study. Children experienced a moderate or marked improvement (final score in CGI 3 to 5). Communication and attention skills were improved. There were also a decrease of rituals, stereotypies and repetitive behaviours. Most common adverse events were increase of impulsivity and restlessness, other events were sleep disturbances and lost of appetite. 6 children needed concomitant medication with carbamacepine and 1 with levopromacine along the study. CONCLUSIONS: These results support that Fluoxetine at doses of 5 ml/day (20 mg/day) could help to improve some symptoms in Pervasive Developmental Disordersand allow to increase the effectiveness of therapies in these patients. More studies are needed to confirm these results.

Adolescent↗
PubMedDate not supplied

[Pattern of usage of new antidepressants in clinical practice].

INTRODUCTION: Data from naturalistic studies have reported differences in the clinical use of antidepressants referring to the need for adjusting doses, treatment duration, tolerability and use of concomitant medication. These differences could be considered as an indicator of the effectiveness of antidepressants in clinical practice settings. OBJECTIVES: It is a naturalistic, retrospective, observational study which objective is to evaluate and compare the pattern of antidepressant use (fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine) and to establish if there is a relation between the different pattern of use and the effectiveness of them. DATA AND METHODS: A retrospective dataset of patients who initiated therapy on fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine with a follow-up period of 6 months was used. Information about clinical characteristics of patients and antidepressant pattern of use were collected. Pattern of antidepressant use were defined as: "initial doses", "upward dose titration", "augmentation strategy", "switching" and "early interruption of treatment". The efficacy of the therapy was assessed by the CGI-improvement. RESULTS: Fluoxetine was the antidepressant more associated with a statistical significance (p = 0.001) to an stable pattern of use (initial doses without upward dose titration, switching or augmentation). After controlling for other observed baseline characteristics, patients who remained on their initial antidepressant therapy, with a stable pattern of use were 1.61 times more likely than patients who had an adjustment to therapy to experience a treatment response. Patients who initiated treatment with sertraline or venlafaxine were 2.155 and 4.831 times less likely, respectively, to experience a response relative to patients who initiated therapy on fluoxetine. CONCLUSIONS: The need to upward dose titration, switching or augmentation in the treatment could be indicated a worse therapeutic control of the symptoms. Patients treated with fluoxetine are in a stable pattern of use more likely than patients in the other antidepressants, this fact is related with better global therapeutic results.

Adult↗
PubMedDate not supplied

[Comparative naturalistic study of the efficacy and tolerability of new antidepressants].

OBJECTIVES: The objective of this study was to compare, in a naturalistic setting, the efficacy and tolerability of currently available Selective Serotonin Re-uptake Inhibitors (SSRIs) and venlafaxine in out-patients from a primary psychiatric-care center. MATERIAL AND METHODS: The sample was composed of 194 patients with mood disorders (major depressive disorder or dysthymic disorder according to the DSM-IV criteria) who initiated treatment either with a SSRI (fluoxetine, fluvoxamine, paroxetine, sertraline, and citalopram) or with venlafaxine. Baseline severity of the mood disorder was assessed using the Hamilton Depression Rating Scale and State-Trait Anxiety Inventory, and therapeutic response was measured with the Clinical Global Impression for Therapeutic Improvement. Tolerability was assessed by recording spontaneously reported adverse experiences. Patients were followed up for six months, with subjects made three o more intermediate visits. RESULTS: There were no significant differences in the efficacy of the antidepressants under study, but there were differences in the incidence and profiles of adverse events. Fluoxetine was associated with the lowest incidence of adverse effects in a logistical regression model. Particular events seemed to be associated with certain treatments; gastrointestinal discomfort (fluvoxamine), tremor (sertraline) and anticholinergic effects (venlafaxine).

Adolescent↗