Research and Clinical Trials on Nefazodone (Serzone, Dutonin)

Nefazodone (Serzone, Dutonin) Clinical Research Trials

From our searchable database at ClinicalTrialsFeeds.org, this list includes all the latest information about clinical trials involving Nefazodone (Serzone, Dutonin).

• Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals
  Status: Completed, Condition Summary: Marijuana Abuse
• Nefazodone in the Treatment of Cocaine Dependence and Depression - 4
  Status: Active, not recruiting, Condition Summary: Cocaine-Related Disorders; Substance-Related Disorders
• Nefazodone in the Treatment of Social Phobia
  Status: Completed, Condition Summary: Social Anxiety Disorder (SAD)
• Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10
  Status: Completed, Condition Summary: Cocaine-Related Disorders
• Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3
  Status: Completed, Condition Summary: Cocaine-Related Disorders

 

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Current Research Literature on Nefazodone (Serzone, Dutonin)

Here are abstracts for some of the latest research articles to have appeared on Nefazodone (Serzone, Dutonin):

Managing the patient with co-morbid depression and an anxiety disorder.

Drugs. 2008; 68(12): 1621-34
Schoevers RA, Van HL, Koppelmans V, Kool S, Dekker JJ
Depression and anxiety disorders frequently co-occur. This type of co-morbidity is associated with higher severity, suicidality, chronicity and treatment resistance. However, available treatment guidelines mainly focus on treatment for singular disorders. The current paper describes diagnostic and treatment issues relevant for adequately addressing patients with depression and an anxiety disorder, using information from both guidelines and a search of recent literature.Apart from differential diagnosis, the diagnostic evaluation should include a thorough assessment of the symptoms of both disorders, preferably by using a structured clinical interview, and an assessment of depression severity in terms of suicidality, psychotic symptoms and impairment. Treatment should first address the primary disorder in terms of severity and risk. As a rule, severe depression should be treated before the anxiety disorder, using antidepressant medication or combined treatment (plus psychotherapy). In less severe pathology, the primary focus may be determined by examining the temporal pattern and the subjective burden of each disorder as experienced by the patient. Treatment is often sequential. Treatment of the primary disorder may or may not relieve the co-morbid disorder as well. If the primary disorder is an anxiety disorder, co-morbid depression generally implies earlier use of an antidepressant. Co-morbid mild depression may also react favourably to psychotherapeutic treatment of the anxiety disorder. Recent literature on concurrent treatment of both depression and anxiety shows that modern antidepressants such as sertraline, paroxetine, fluoxetine, venlafaxine, nefazodone and bupropion have demonstrated efficacy in relieving both depressive and anxiety symptoms compared with placebo. Head-to-head comparisons, although relatively scarce, tend to show superiority over tricyclic antidepressants. Venlafaxine was found to be more effective than fluoxetine in some studies. However, these results should be interpreted with caution because studies vary considerably in terms of patient selection, assessment of anxiety and primary outcome measures. Only one randomized controlled trial compared atypical antipsychotics with placebo. Psychotherapy was generally shown to have a beneficial effect on the co-morbid conditions, and available evidence appears to favour combined treatment. The results should be interpreted with caution because the number of studies on this issue was relatively small, with considerable clinical and methodological heterogeneity.

High throughput and sensitive determination of trazodone and its primary metabolite, m-chlorophenylpiperazine, in human plasma by liquid chromatography-tandem mass spectrometry.

J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Aug 1; 871(1): 44-54
Patel BN, Sharma N, Sanyal M, Shrivastav PS
A precise, sensitive and high throughput liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for simultaneous determination of trazodone (TRZ) and its primary metabolite, m-chlorophenylpiperazine (mCPP), in human plasma was developed and validated. The analytes and the internal standard-nefazodone were extracted from 500muL aliquots of human plasma via liquid-liquid extraction in n-hexane. Chromatographic separation was achieved in a run time of 2.5min on a Betabasic cyano column (100mmx2.1mm, 5mum) under isocratic conditions. Detection of analytes and IS was done by tandem mass spectrometry, operating in positive ion and multiple reaction monitoring (MRM) acquisition mode. The protonated precursor to product ion transitions monitored for TRZ, mCPP and IS were m/z 372.2-->176.2, 197.2-->118.1 and 470.5-->274.6 respectively. The method was fully validated for its sensitivity, selectivity, accuracy and precision, matrix effect, stability study and dilution integrity. A linear dynamic range of 10.0-3000.0ng/mL for TRZ and 0.2-60.0ng/mL for mCPP was evaluated with mean correlation coefficient (r) of 0.9986 and 0.9990 respectively. The intra-batch and inter-batch precision (%CV) across five validation runs (LLOQ, lower limit of quantitation; LQC, low quality control; MQC, middle quality control; HQC, high quality control and ULOQ, upper limit of quantitation) was

What moderator characteristics are associated with better prognosis for depression?

Neuropsychiatr Dis Treat. 2005 Mar; 1(1): 51-7
Trivedi MH, Morris DW, Pan JY, Grannemann BD, John Rush A
A retrospective data analysis was conducted to evaluate the usefulness of baseline characteristics in predicting treatment response to antidepressant medication in 97 outpatients with nonpsychotic major depression treated for up to sixteen weeks with nefazodone. Baseline demographics (gender), illness features (symptom severity, length of illness, length of current episode, number of episodes, age of onset, longitudinal subtype, endogenicity, melancholia, family history of mood disorders), and social features (living status) were evaluated. Response to treatment was defined as a >/= 50% reduction in the 17-item Hamilton Rating Scale for Depression (HRSD(17)) score. The results of a survival analysis indicated that patients with shorter histories of illness (< 4 years), a negative family history of depression, and those who were either married or were living with someone were more likely to have a positive outcome during the acute phase treatment of depression. The main findings are consistent with extensive previous literature indicating a better short-term outcome of depression where illness is shorter, where there is no family history, and where there is better social support.

Faster remission of chronic depression with combined psychotherapy and medication than with each therapy alone.

J Consult Clin Psychol. 2008 Jun; 76(3): 459-67
Manber R, Kraemer HC, Arnow BA, Trivedi MH, Rush AJ, Thase ME, Rothbaum BO, Klein DN, Kocsis JH, Gelenberg AJ, Keller ME
The main aim of the present novel reanalysis of archival data was to compare the time to remission during 12 weeks of treatment of chronic depression following antidepressant medication (n = 218), psychotherapy (n = 216), and their combination (n = 222). Cox regression survival analyses revealed that the combination of medication and psychotherapy produced full remission from chronic depression more rapidly than either of the single modality treatments, which did not differ from each other. Receiver operating characteristic curve analysis was used to explore predictors (treatment group, demographic, clinical, and psychosocial) of remission. For those receiving the combination treatment, the most likely to succeed were those with low baseline depression (24-item Hamilton Rating Scale for Depression [HRSD; M. Hamilton, 1967] score < 26) and those with high depression scores but low anxiety (HRSD = 26 and Hamilton Anxiety Rating Scale [M. Hamilton, 1959] < 14). Both profiles were associated with at least 40% chance of attaining full remission. The model did not identify predictors for those receiving medication or psychotherapy alone, and it did not distinguish between the 2 monotherapies. The authors conclude that combined antidepressant medications and psychotherapy result in faster full remission of chronic forms of major depressive disorder.

Cellular imaging predictions of clinical drug-induced liver injury.

Toxicol Sci. 2008 Sep; 105(1): 97-105
Xu JJ, Henstock PV, Dunn MC, Smith AR, Chabot JR, de Graaf D
Drug-induced liver injury (DILI) is the most common adverse event causing drug nonapprovals and drug withdrawals. Using drugs as test agents and measuring a panel of cellular phenotypes that are directly linked to key mechanisms of hepatotoxicity, we have developed an in vitro testing strategy that is predictive of many clinical outcomes of DILI. Mitochondrial damage, oxidative stress, and intracellular glutathione, all measured by high content cellular imaging in primary human hepatocyte cultures, are the three most important features contributing to the hepatotoxicity prediction. When applied to over 300 drugs and chemicals including many that caused rare and idiosyncratic liver toxicity in humans, our testing strategy has a true-positive rate of 50-60% and an exceptionally low false-positive rate of 0-5%. These in vitro predictions can augment the performance of the combined traditional preclinical animal tests by identifying idiosyncratic human hepatotoxicants such as nimesulide, telithromycin, nefazodone, troglitazone, tetracycline, sulindac, zileuton, labetalol, diclofenac, chlorzoxazone, dantrolene, and many others. Our findings provide insight to key DILI mechanisms, and suggest a new approach in hepatotoxicity testing of pharmaceuticals.