Research and Clinical Trials on Fluoxetine (Prozac, Sarafem)

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By Dr Greg Mulhauser

This list of current clinical research trials on Fluoxetine (Prozac, Sarafem) is followed by a short set of abstracts from the most recent research articles published on the drug.

Article Contents

Fluoxetine (Prozac, Sarafem) Clinical Research Trials

From our searchable database at ClinicalTrialsFeeds.org, this list includes all the latest information about clinical trials involving Fluoxetine (Prozac, Sarafem).

 

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Current Research Literature on Fluoxetine (Prozac, Sarafem)

Here are abstracts for some of the latest research articles to have appeared on Fluoxetine (Prozac, Sarafem):

Antidepressant and anxiolytic effects of selective 5-HT(6) receptor agonists in rats.

Psychopharmacology (Berl). 2010 Mar 9;
Carr GV, Schechter LE, Lucki I
RATIONALE: Although selective serotonin reuptake inhibitors (SSRIs) produce clinical therapeutic effects on depression and anxiety through augmentation of serotonergic neurotransmission, there is little known about the potential contributions of the 5-HT(6) receptor in the treatment of mood disorders. OBJECTIVES: The aim of this study was to test the potential antidepressant-like and anxiolytic-like effects of the 5-HT(6) receptor agonists WAY-208466 and WAY-181187 using established behavioral tests in rats. METHODS: In order to determine if the 5-HT(6) receptor agonists possess antidepressant-like activity, rats were treated with WAY-208466 or WAY-181187 and tested in the modified rat forced swim test (FST). Also, the potential anxiolytic-like effects of WAY-208466 and WAY-181187 were measured using the defensive burying (DB) test and novelty-induced hypophagia (NIH) test. RESULTS: WAY-208466 and WAY-181187 produced both antidepressant-like and anxiolytic-like effects. Both compounds decreased immobility and increased swimming behavior in the FST. The effects of the 5-HT(6) receptor agonists were similar to those seen after treatment with the SSRI fluoxetine. Both 5-HT(6) receptor agonists also decreased burying duration in the DB test, indicative of anxiolytic activity in the test. The anxiolytic effects of WAY-208466 were reproduced in the NIH test. Assessment of the anxiolytic effects of WAY-181187 in the NIH was confounded by alterations in home cage feeding behavior. CONCLUSIONS: These findings suggest that 5-HT(6) receptor agonists may represent a new class of potential antidepressant and anxiolytic compounds and could possess a number of advantages over currently available treatments, including rapid onset of anxiolytic efficacy.

Impact of Childhood Trauma on Treatment Outcome in the Treatment for Adolescents with Depression Study (TADS).

J Am Acad Child Adolesc Psychiatry. 2010 Feb; 49(2): 132-40
Lewis CC, Simons AD, Nguyen LJ, Murakami JL, Reid MW, Silva SG, March JS
OBJECTIVE: The impact of childhood trauma was examined in 427 adolescents (54% girls, 74% Caucasian, mean = 14.6, SD = 1.5) with major depressive disorder participating in the Treatment for Adolescents with Depression Study (TADS). METHOD: TADS compared the efficacy of cognitive behavioral therapy (CBT), fluoxetine (FLX), their combination (COMB), and placebo (PBO). Teens were separated into four trauma history groups: (1) no trauma; (2) trauma, no abuse; (3) physical abuse; (4), and sexual abuse. The effects of treatment and trauma history on depression severity across 12 weeks of acute treatment, as measured by the Children's Depression Rating Scale-Revised (CDRS-R), were examined. RESULTS: A significant trauma-by-treatment-by-time interaction indicated that trauma history moderated treatment. The Week 12 primary efficacy findings previously reported by TADS were replicated in the no trauma group (n = 201): COMB = FLX > CBT = PBO. No significant differences in treatment arms were observed among the trauma, no abuse, or physical abuse group. Teens with a history of sexual abuse treated with COMB, FLX, and PBO showed significant and equivalent improvement on the CDRS-R (mean 45). Baseline suicidality and self-reported depression were significantly related to a history of sexual abuse. CONCLUSIONS: The study was limited by the level of detail regarding childhood traumatic experiences. Results are discussed in terms of the implications for treating depressed adolescents with traumatic backgrounds.Clinical Trials Registry Information: Treatment for Adolescents with Depression Study; http://www.clinicaltrials.gov, NCT00006286.

Behavioural Satiety Sequence (BSS): Separating wheat from chaff in the behavioural pharmacology of appetite.

Pharmacol Biochem Behav. 2010 Mar 6;
Rodgers RJ, Holch P, Tallett AJ
The history of anti-obesity drug development is far from glorious, with transient magic bullets and only a handful of agents currently licensed for clinical use. In view of recent progress in our understanding of the multiplicity of signalling pathways involved in appetite regulation, and the resultant deluge of reports on the anorectic efficacy of novel therapies, it seems timely to stress the need to differentiate treatments that suppress intake by primary means from those that only indirectly achieve this endpoint. The current article reviews the conceptual history of the behavioural satiety sequence (BSS), also known as the behavioural sequence of satiety, post-ingestive satiety, and the post-prandial satiety sequence. Early research confirmed that natural satiation, produced by a caloric load on the gut, is associated with a predictable transition from feeding through grooming to resting. Although many less naturalistic manipulations are also capable of reducing food intake, very few do so without disrupting the normal structure of this feeding cycle. Thus, while CCK and d-fenfluramine reduce intake by accelerating but otherwise maintaining the integrity of the BSS, other anorectic interventions disrupt the BSS through response competition (e.g. d-amphetamine), nausea/discomfort (e.g. lithium chloride) and/or interference with taste-mediated positive feedback (e.g. quinine adulteration of the diet). A substantial literature now strongly supports the specific involvement of serotonin 5-HT(1B) and 5-HT(2C) receptor subtypes in satiety and in the anorectic effect of agents such as fenfluramine and fluoxetine. Recent BSS analyses have also identified rather selective anorectic profiles for the dual noradrenaline and 5-HT reputake inhibitor sibutramine, the orexin-1 receptor antagonist SB-334867, and the broad spectrum opioid receptor antagonist naloxone. However, similar analyses have offered little/no support for the anorectic potential of the gut peptide PYY(3-36) while the acute anorectic efficacy of cannabinoid CB1 receptor antagonist/inverse agonists appears largely to be secondary to response competition. In contrast, studies with low-dose combinations of naloxone and CB1 receptor antagonist/inverse agonists have very recently confirmed the potential of drug polytherapies not only in appetite suppression but also in attenuating/eliminating unwanted side-effects. In sum, as BSS analysis offers a reliable means of differentiating the wheat (primary anorectics) from the chaff (secondary anorectics), it should form an integral part of early phase testing in any anti-obesity drug screening programme.

QT Alterations in Psychopharmacology: Proven Candidates and Suspects.

Curr Drug Saf. 2010 Jan 1; 5(1): 97-104
Alvarez PA, Pahissa J
Psychotropics are among the most common causes of drug induced acquired long QT syndrome. Blockage of Human ether-a-go-go-related gene (HERG) potassium channel by psychoactive drugs appears to be related to this adverse effect. Antipsychotics such as haloperidol, thioridazine, sertindole, pimozide, risperidone, ziprasidone, quetiapine, olanzapine and antidepressants such as amitriptyline, imipramine, doxepin, trazadone, fluoxetine depress the delayed rectifier potassium current (IKr) in a dose dependent manner in experimental models. The frequency of QTc prolongation (more than 456ms) in psychiatric patients is estimated to be 8%. Age over 65 years, tricyclic antidepressants (TCA), thioridazine, droperidol, olanzapine, and higher antipsychotic doses were predictors of significant QTc prolongation. In large epidemiological controlled studies a dose dependent increased risk of sudden death has been identified in current users of antipsychotics (conventional and atypical) and of TCA. Thioridazine and haloperidol shared a similar relative risk of SCD. Lower doses of risperidone had a higher relative risk than haloperidol for cardiac arrest and ventricular arrhythmia. No increased risk was identified in current users of selective serotonin reuptake inhibitors (SSRI). Cases of TdP have been reported with thioridazine, haloperidol, ziprazidone, olanzapine and TCA. Evidence of QTc prolongation with sertindole is significant and this drug has not been approved by the Food and Drugs Administration (FDA). A large trial is ongoing to evaluate the cardiac risk profile of ziprazidone and olanzapine. Selective serotonin reuptake inhibitors have been associated with QTc prolongation but no cases of TdP have been reported with the use of these agents. There are no reported cases of lithium induced TdP. Risk factors for drug induced LQT syndrome and TdP include: female gender, concomitant cardiovascular disease, substance abuse, drug interactions, bradychardia, electrolyte disorders, anorexia nervosa, and congenital Long QT syndrome. Careful selection of the psychotropic and identification of patient's risk factors for QTc prolongation is applicable in current clinical practice.

Salvage use of citalopram for treatment of fluoxetine-resistant premature ejaculation in recently married men: a prospective clinical trial.

Urol J. 2010; 7(1): 40-4
Dadfar MR, Baghinia MR
Introduction: A wide variety of therapeutic modalities have been tried for treatment of premature ejaculation. Selective serotonin reuptake inhibitors are from the latest and most effective medical agents. Among these drugs, fluoxetine hydrochloride has been used for some years in our institutions with considerable drug untoward effects and significant failure rates. We tried to salvage treatment process by using citalopram in fluoxetine-resistant patients. Materials and Methods: In a prospective clinical trial, we used citalopram hydrobromide as a salvage agent in 16 newly married men with premature ejaculation who experienced a history of unsuccessful treatment with fluoxetine hydrochloride. Intravaginal ejaculation latency time (IVELT) was recorded by a stopwatch before and after the treatment, and a 5-stage visual scale was designed and used to compare patients' sexual satisfaction levels during the 1-month treatment period. Results: The IVELT and sexual satisfaction levels both significantly improved after citalopram prescription. The mean measured IVELT was 0.388 +/- 0.212 minutes before the treatment, which increased to 4.313 +/- 2.886 minutes after the treatment. The reported drug untoward effects were mild. Citalopram was ineffective only in 1 patient, which was discontinued after 4 weeks. Conclusion: Our study showed that citalopram is effective and safe in the treatment of premature ejaculation in newly married men after failed treatment with fluoxetine.

 

This page was last reviewed by Dr Greg Mulhauser, Sunday, 31 January 2010.

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