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A double-blind, randomized pilot study for comparison of Melissa officinalis L. and Lavandula angustifolia Mill. with Fluoxetine for the treatment of depression.
Araj-Khodaei, M, Noorbala, AA, Yarani, R, Emadi, F, Emaratkar, E, Faghihzadeh, S, Parsian, Z, Alijaniha, F, Kamalinejad, M, Naseri, M
BMC complementary medicine and therapies. 2020;(1):207
Abstract
BACKGROUND Depression has rapidly progressed worldwide, and the need for an efficient treatment with low side effect has risen. Melissa officinalis L and Lavandula angustifolia Mill have been traditionally used in Asia for the treatment of depression. Many textbooks of traditional Persian medicine refer to these herbs for the treatment of depression while there are no adequate clinical trials to support this claim. The present study aimed to evaluate the efficacy of M. officinalis and L. angustifolia compared to fluoxetine for the treatment of mild to moderate depression in an 8-week randomized, double-blind clinical trial. METHODS Forty-five adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) for major depression, were randomly assigned to 3 groups to daily receive either M. officinalis (2 g) or L. angustifolia (2 g) or fluoxetine (20 mg) and were assessed in weeks 0, 2, 4 and 8 by the Hamilton Rating Scale for Depression (HAM-D) including 17 items. RESULTS Our study showed that M. officinalis and L. angustifolia effect similar to fluoxetine in mild to moderate depression. (F = 0.131, df = 2,42, p = 0.877). CONCLUSION Due to some restrictions in this study including absence of placebo group, large-scale trials are needed to investigate the anti-depressant effect of these two herbs with more details. TRIAL REGISTRATION IRCT2014061718126N1 . Registration date: 2015-06-04-"Retrospectively registered".
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Pharmacologic Treatment of Eating Disorders.
Crow, SJ
The Psychiatric clinics of North America. 2019;(2):253-262
Abstract
Medications are a useful adjunct to nutritional and psychotherapeutic treatments for eating disorders. Antidepressants are commonly used to treat bulimia nervosa; high-dose fluoxetine is a standard approach, but many other antidepressants can be used. Binge eating disorder can be treated with antidepressants, with medications that diminish appetite, or with lisdexamfetamine. Anorexia nervosa does not generally respond to medications, although recent evidence supports modest weight restoration benefits from olanzapine.
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Effect of fluoxetine on three-year recurrence in acute ischemic stroke: A randomized controlled clinical study.
He, Y, Cai, Z, Zeng, S, Chen, S, Tang, B, Liang, Y, Chang, X, Guo, Y
Clinical neurology and neurosurgery. 2018;:1-6
Abstract
OBJECTIVE To evaluate the effect of fluoxetine on three-year recurrence rate of acute ischemic stroke. PATIENTS AND METHODS 404 enrolled patients with acute ischemic stroke were randomly divided into control and treatment groups, and underwent conventional secondary preventive therapy for ischemic stroke. In addition, the treatment group was administered fluoxetine (20 mg daily for 90 days). A three-year follow-up was performed, and indicators related to risk factors of stroke were assessed at day 90 of follow-up. The effect of fluoxetine on the three-year recurrence rate of acute ischemic stroke was evaluated by survival analysis, as well as multifactor Cox regression analysis. RESULTS The values of systolic blood pressure, blood total cholesterol, blood low density lipoprotein and glycosylated hemoglobin at day 90 of follow-up were significantly lower in treatment group than control group (P = 0.002, P = 0.002, P = 0.018, P = 0.011, respectively). The occurrence rates of epilepsy, gastrointestinal bleeding, syncope, allergic reactions, hemorrhagic infarction, and death were not significantly different between the two groups during the follow-up (P > 0.05). The recurrence-free survival rate of ischemic stroke was significantly lower in the treatment group than control group as assessed by the Kaplan-Meier test (85.1% Vs 75.7%, P = 0.016), as well as the recurrence-free survival rate after day 90 in the three-year follow-up (87.0% Vs 79.3%, P = 0.043). Multifactor Cox regression analysis demonstrated treatment with fluoxetine was an independent factor reducing three-year recurrence in acute ischemic stroke (HR = 0.594, 95% CI: 0.376-0.938). CONCLUSION Treatment with fluoxetine for 90 days after acute ischemic stroke significantly reduces the three-year recurrence rate of ischemic stroke.
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The effects of a single dose of fluoxetine on practice-dependent plasticity.
McDonnell, MN, Zipser, C, Darmani, G, Ziemann, U, Müller-Dahlhaus, F
Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology. 2018;(7):1349-1356
Abstract
OBJECTIVE To determine whether a single dose of fluoxetine increases corticomotoneuronal excitability, motor performance and practice-dependent plasticity. METHODS Twelve healthy adults completed this placebo-controlled, pseudo-randomized, double-blind crossover study. Transcranial magnetic stimulation (TMS) was used to assess corticomotoneuronal excitability, and two uni-axial accelerometers measured kinetics of fastest possible ballistic voluntary thumb movements and TMS-evoked thumb movements. Six hours after administration of either 20 mg of the serotonin reuptake inhibitor fluoxetine or placebo, participants practiced ballistic thumb movements in the direction opposite to the TMS-evoked thumb movements. The primary outcome of this study was the proportion of thumb movements that fell within the target-training zone (TTZ) during and for 30 min after the practice. RESULTS All participants demonstrated practice-dependent plasticity evidenced by an increase of TMS-evoked thumb movements falling into the TTZ (P = 0.045), with no difference between drugs. There was a significant increase in peak acceleration of the practiced voluntary thumb movements (P = 0.002), but no DRUG by TIME interaction. Motor-evoked potential amplitudes were not changed by drug intake or practice. CONCLUSIONS A single dose of 20 mg of fluoxetine did not enhance corticomotoneuronal excitability, performance of a ballistic thumb movement task, or practice-dependent plasticity in healthy adults. SIGNIFICANCE Longer administration fluoxetine may be necessary to enhance motor performance and plasticity.
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Comparison of Saffron versus Fluoxetine in Treatment of Mild to Moderate Postpartum Depression: A Double-Blind, Randomized Clinical Trial.
Kashani, L, Eslatmanesh, S, Saedi, N, Niroomand, N, Ebrahimi, M, Hosseinian, M, Foroughifar, T, Salimi, S, Akhondzadeh, S
Pharmacopsychiatry. 2017;(2):64-68
Abstract
Introduction: Postpartum depression is a common mental health problem that is associated with maternal suffering. The aim of this double-blind clinical trial was to compare safety and efficacy of saffron and fluoxetine in treatment of mild to moderate postpartum depression. Methods: This was a 6-week, double-blind, randomized clinical trial. Subjects were women aged 18-45 years with mild to moderate postpartum depression who had Hamilton Depression Rating Scale (HDRS 17-item) score≤18. Eligible participants were randomized to receive either a capsule of saffron (15 mg capsule) or fluoxetine (20 mg capsule) twice daily for 6 weeks. The primary outcome measure was to evaluate efficacy of saffron compared to fluoxetine in improving depressive symptoms (HDRS score). Results: There was no significant effect for time×treatment interaction on HDRS score [F (4.90, 292.50)=1.04, p=0.37] between the 2 groups. 13 (40.60%) patients in the saffron group experienced complete response (≥50% reduction in HDRS score) compared with 16 (50%) in the fluoxetine group and the difference between the 2 groups was not significant in this regard (p=0.61). Frequency of adverse events was not significantly different between the treatment groups. Discussion: The results of this study may suggest that saffron is a safe alternative medication for improving depressive symptoms of postpartum depression. Nevertheless, it should be mentioned that the trial is not well powered and should be considered a preliminary study. Therefore, large clinical trials with longer treatment periods and comparison with placebo group would be appropriate for future studies.
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A crossover study comparing gabapentin and fluoxetine for the treatment of vasomotor symptoms among postmenopausal women.
Rahmanian, M, Mohseni, A, Ghorbani, R
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2015;(1):87-90
Abstract
OBJECTIVE To compare the effectiveness of fluoxetine and gabapentin for treatment of vasomotor symptoms (VMS) after the menopause. METHODS Between March 2011 and March 2012, a randomized crossover study was performed at a center in Semnan, Iran, among postmenopausal women aged 45-57 years with hot flashes (≥2 per day for previous 4 months) for which they had received no previous treatment. Participants were divided into two groups with consecutive numbers assigned in order of recruitment. In the first treatment round (4 weeks), group A received 20mg/day fluoxetine and group B received 300 mg/day gabapentin. After a 2-week washout period, group A received gabapentin and group B received fluoxetine in a second round (4 weeks). Information about VMS was obtained with the Greene Climacteric Scale questionnaire. Participants and all investigators except one were masked to group assignment. RESULTS Data for 79 participants (39 in group A, 40 in group B) were analyzed. In both treatment rounds, gabapentin caused greater reductions in the severity of hot flashes than did fluoxetine (P<0.001 for both). After the first round of treatment, those who had received gabapentin reported greater reductions in the severity of night sweats (P<0.001). CONCLUSION Gabapentin at a dose of 300 mg/day is more effective for treatment of VMS among postmenopausal women than is 20 mg/day fluoxetine. Iranian Registry of Clinical Trials:IRCT2014092711019N3.
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A comparative study of five centrally acting drugs on the pharmacological treatment of obesity.
Suplicy, H, Boguszewski, CL, dos Santos, CM, do Desterro de Figueiredo, M, Cunha, DR, Radominski, R
International journal of obesity (2005). 2014;(8):1097-103
Abstract
CONTEXT No long-term studies have compared centrally acting drugs for treating obesity. OBJECTIVE To compare the efficacy and safety of diethylpropion (DEP), fenproporex (FEN), mazindol (MZD), fluoxetine (FXT) and sibutramine (SIB) in promoting weight loss. DESIGN AND SETTING A prospective, randomized, placebo (PCB)-controlled study conducted at a single academic institution. PATIENTS A total of 174 obese premenopausal women. INTERVENTION Participants randomly received DEP 75 mg (n=28), FEN 25 mg (n=29), MZD 2 mg (n=29), SIB 15 mg (n=30), FXT 20 mg (n=29) or PCB (n=29) daily over 52 weeks. Diet and physical activity were encouraged. MAIN OUTCOME MEASURES The primary endpoints were changes in body weight and the proportion of women who achieved at least 5% weight loss by week 52 in the intent-to-treat population. Other measurements included anthropometry, safety, metabolic and cardiovascular parameters. RESULTS Weight loss was greater than PCB (-3.1±4.3 kg) with DEP (-10.0±6.4 kg; P<0.001), SIB (-9.5±5.9 kg; P<0.001), FEN (-7.8±6.9 kg; P<0.01) and MZD (-7.4±4.9 kg; P<0.01) but not with FXT (-2.5±4.1 kg). Ten (33.3%) women lost⩾5% of their initial weight with PCB, compared with 20 (71.4%; P<0.001) with DEP, 20 (69%; P<0.02) with FEN, 21 (72.4%; P<0.01) with MZD, 22 (73.3%; P<0.001) with SIB and 10 (35.5%) with FXT. Each medically treated group experienced more adverse events compared with PCB (P<0.001). Compared with PCB, constipation was more prevalent with DEP, SIB and MZD (P<0.01); anxiety was more prevalent with DEP (P=0.01); and irritability occurred more frequently with DEP and FEN (P=0.02). Significant improvements in the depression and anxiety scores, binge-eating episodes and quality of life correlated with weight loss. CONCLUSION The centrally acting drugs DEP, FEN, MZD and SIB were more effective than PCB in promoting weight loss in obese premenopausal women, with a satisfactory benefit-risk profile.
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A randomized double-blind comparison of fluoxetine augmentation by high and low dosage folic acid in patients with depressive episodes.
Venkatasubramanian, R, Kumar, CN, Pandey, RS
Journal of affective disorders. 2013;(2):644-8
Abstract
BACKGROUND Though encouraging evidence exists for the use of folic acid as an augmenting agent to antidepressants, evidence regarding its optimal dosage is lacking. METHODS Forty-two female out-patients with moderate (with or without somatic syndrome) or severe depressive episodes (without psychotic symptoms) diagnosed as per ICD-10 criteria, were randomized in a double-blind fashion to receive either 20 mg fluoxetine and a relatively low dose folic acid (1.5 mg/day; n=23; Group I) or 20 mg fluoxetine and high dose folic acid (5 mg/day; n=19; Group II). Primary outcome measures were weekly changes of scores on Hamilton Depression Rating Scale (HDRS) and Beck Depression Inventory (BDI) for 6 weeks. RESULTS Group II patients showed greater improvement in both HDRS [Mean (SD) baseline HDRS score=21 (2.3) for group I and 20.0 (1.4) for group-II; time X group interaction effect: p=0.01] and BDI [Mean (SD) baseline BDI score=25.1 (5.2) for group-1 and 23.1 (2.7) for group-II; time X group interaction effect: p=0.01]. With regard to HDRS, 7 (36.8%) group II patients remitted compared to 2 (8.7%) group I patients (p=0.03); 9 (47.4%) patients of group II responded when compared to 6 (26.1%) from group I (p=0.15). When BDI was considered, 5 (26.3%) group II patients remitted when compared to 2 (8.7%) from group I (p=0.13); 10 patients (52.6%) from group II responded when compared to 5 (21.7%) from group I (p=0.04). No adverse effects were noted in either group. LIMITATIONS Lack of a placebo arm and small sample size. CONCLUSION Compared to folic acid 1.5 mg/day, augmentation with 5 mg/day may be more beneficial in female patients with depressive episodes taking fluoxetine 20 mg/day.
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Flow rates and inorganic composition of whole saliva in purging bulimic patients treated with a fluoxetine.
Paszynska, E, Linden, RW, Slopien, A, Rajewski, A
The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry. 2011;(4):282-7
Abstract
OBJECTIVES The current study established whether vomiting bulimic and/or non-bulimic depressive patients, both treated with a serotonin reuptake inhibitor (fluoxetine), have changes in their whole salivary secretion and inorganic components: Na(+), K(+), Ca(2+). METHODS From 108 female subjects, namely bulimics (Group B) (fluoxetine: 40 mg/day) (n=33), non-bulimic depressives (Group D) (fluoxetine: 20 mg/day) (n=25) and a Group C of 50 healthy controls, unstimulated and stimulated saliva was collected. The concentrations of Na(+), K(+), Ca(2+) were determined by colorimetric photometry method (Effox 5053, Eppendorf, Germany). RESULTS The bulimic group reported significant lower output in salivary flow and sodium concentration. In the group (D) only flow was lower than in healthy controls but not significant. CONCLUSION This study supports the hypothesis that salivary flow is an unreliable indicator of bulimia, the lack of increase in sodium level in stimulated saliva in bulimic subjects could be a more reliable confirmation of the eating disorder.
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hERG subunit composition determines differential drug sensitivity.
Abi-Gerges, N, Holkham, H, Jones, EM, Pollard, CE, Valentin, JP, Robertson, GA
British journal of pharmacology. 2011;(2b):419-32
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Abstract
BACKGROUND AND PURPOSE The majority of human ether-a-go-go-related gene (hERG) screens aiming to minimize the risk of drug-induced long QT syndrome have been conducted using heterologous systems expressing the hERG 1a subunit, although both hERG 1a and 1b subunits contribute to the K+ channels producing the repolarizing current I(Kr) . We tested a range of compounds selected for their diversity to determine whether hERG 1a and 1a/1b channels exhibit different sensitivities that may influence safety margins or contribute to a stratified risk analysis. EXPERIMENTAL APPROACH We used the IonWorks™ plate-based electrophysiology device to compare sensitivity of hERG 1a and 1a/1b channels stably expressed in HEK293 cells to 50 compounds previously shown to target hERG channels. Potency was determined as IC₅₀ values (µM) obtained from non-cumulative, eight-point concentration-effect curves of normalized data, fitted to the Hill equation. To minimize possible sources of variability, compound potency was assessed using test plates arranged in alternating columns of cells expressing hERG 1a and 1a/1b. KEY RESULTS Although the potency of most compounds was similar for the two targets, some surprising differences were observed. Fluoxetine (Prozac) was more potent at blocking hERG 1a/1b than 1a channels, yielding a corresponding reduction in the safety margin. In contrast, E-4031 was a more potent blocker of hERG 1a compared with 1a/1b channels, as previously reported, as was dofetilide, another high-affinity blocker. CONCLUSIONS AND IMPLICATIONS The current assays may underestimate the risk of some drugs to cause torsades de pointes arrhythmia, and overestimate the risk of others.