Research and Clinical Trials on Quetiapine (Seroquel)

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By Dr Greg Mulhauser

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

Article Contents

Quetiapine (Seroquel) Clinical Research Trials

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

 

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Current Research Literature on Quetiapine (Seroquel)

Here are abstracts for some of the latest research articles to have appeared on Quetiapine (Seroquel):

Long-term response to successful acute pharmacological treatment of psychotic depression.

J Affect Disord. 2009 Oct 30;
Wijkstra J, Burger H, van den Broek WW, Birkenhäger TK, Janzing JG, Boks MP, Bruijn JA, van der Loos ML, Breteler LM, Verkes RJ, Nolen WA
BACKGROUND: Data about follow-up after acute pharmacological treatment of psychotic depression are scarce. METHODS: A 4month open follow-up was done, preferentially with same medication as during acute treatment, of patients (n=59) with DSM-IV-TR major depressive disorder with psychotic features, aged 18 to 65years, who had completed as responders an acute double-blind 7week trial with imipramine, venlafaxine or venlafaxine plus quetiapine. Main outcome measures were Hamilton Rating Scale for Depression and Clinical Global Impression Scale. RESULTS: Six patients dropped out during the 4month follow-up. Almost all patients (86.4%; 51/59) remained responder while remission rate increased from 59.3% (35/59) to 86.8% (46/53), independent of treatment. Relapse rate was low (3.8%; 2/53). Tolerability was good. Weight increased with all treatments. LIMITATIONS: Limitations were the limited sample size and consequent limited statistical power. The treatment during follow-up was not double-blind. CONCLUSIONS: Continuation treatment with the same medication that was effective in the acute treatment trial, remained effective during the 4month follow-up in many patients leading to further improvement, and was well tolerated.

Lack of effect of stimulant combination with second-generation antipsychotics on weight gain, metabolic changes, prolactin levels, and sedation in youth with clinically relevant aggression or oppositionality.

J Child Adolesc Psychopharmacol. 2009 Oct; 19(5): 563-73
Penzner JB, Dudas M, Saito E, Olshanskiy V, Parikh UH, Kapoor S, Chekuri R, Gadaleta D, Avedon J, Sheridan EM, Randell J, Malhotra AK, Kane JM, Correll CU
BACKGROUND: Second-generation antipsychotics (SGAs) are associated with weight gain, metabolic abnormalities, sedation/sleep disturbance, and prolactin abnormalities, especially in youths. Although stimulants have opposing dopamine receptor and adverse effects, it is unclear whether stimulant co-treatment counteracts the therapeutic or side effects of antipsychotics. METHODS: This was a naturalistic cohort study including 153 antipsychotic trials in youths aged 4-19 (mean, 11.3 +/- 3.0) years, started on an SGA for clinically significant aggression or oppositionality associated with oppositional defiant disorder, conduct disorder, disruptive behavior disorder not otherwise specified (NOS), impulse control disorder NOS, intermittent explosive disorder, Tourette's disorder, autistic disorder, and pervasive developmental disorder NOS. Patients underwent fasting assessments of body composition, lipids, glucose, insulin, prolactin, sedation, and general efficacy at baseline, weeks 4, 8, and 12, comparing patients co-prescribed stimulants (n = 71) with those not co-prescribed stimulants (n = 82). RESULTS: Patients received risperidone (33.3%), aripiprazole (29.4%), quetiapine (18.4%), olanzapine (11.8%), ziprasidone (5.9%), or clozapine (0.7%). With and without adjustment for differences in baseline variables (sex, prior stimulant use, primary Diagnostic and Statistical Manual of Mental Disorders, 4(th) edition [DSM-IV] disorders, co-morbid attention-deficit/hyperactivity disorder [ADHD], present in 46.3% of youths not receiving stimulants, and some body composition parameters), patients on versus off stimulants did not differ on any of the assessed outcomes (all p values > or = 0.1). CONCLUSIONS: In contrast to guidelines, stimulant use did not precede or accompany antipsychotic use during the current episode of aggression/oppositionality in almost half of those youths who had aggressive/oppositional behavior and a DSM-IV diagnosis of ADHD. At the clinically prescribed doses, stimulant co-treatment of SGAs did not seem to significantly reduce antipsychotic effects on body composition, metabolic parameters, prolactin, sedation, and broad efficacy.

Impact of antipsychotic medication on family burden in schizophrenia: Longitudinal results of CATIE trial.

Schizophr Res. 2009 Oct 27;
Perlick DA, Rosenheck RA, Kaczynski R, Swartz MS, Canive JM, Lieberman JA
BACKGROUND: This study evaluated the effectiveness of first- and second-generation antipsychotics in reducing family burden associated with schizophrenia. METHODS: The family caregivers of 623 SCID-diagnosed patients enrolled in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) randomly assigned to a first-generation antipsychotic (perphenazine) or one of four second-generation drugs (olanzapine, quetiapine, risperidone or ziprasidone) were interviewed about resources provided and stresses experienced at baseline and followed for 18months. Patient symptoms, side effects and service use were assessed as well. Hierarchical regression analyses evaluated the effect of treatment assignment on four burden factors: problem behavior, resource demands and disruption, impairment in activities of daily living and patient helpfulness. Intention-to-treat analyses with all available observations classified based on initial treatment assignment, including observations after medications changed were followed by secondary analyses excluding observations after the first medication change, i.e. only considering initial medication. RESULTS: Despite significant reductions on the problem behavior and resource demands/disruption factors, there were no significant differences between perphenazine and any of the second-generation medications. When only initial treatment period observations were included, patients were perceived as more helpful when medicated with perphenazine as compared to risperidone. In comparisons between second-generation drugs, patients on quetiapine were perceived as more helpful than those on risperidone (p=0.004). CONCLUSION: In this 18-month randomized trial, there was no evidence of superiority of second-generation antipsychotics in relieving family burden.

Cardiometabolic risk of second-generation antipsychotic medications during first-time use in children and adolescents.

JAMA. 2009 Oct 28; 302(16): 1765-73
Correll CU, Manu P, Olshanskiy V, Napolitano B, Kane JM, Malhotra AK
CONTEXT: Cardiometabolic effects of second-generation antipsychotic medications are concerning but have not been sufficiently studied in pediatric and adolescent patients naive to antipsychotic medication. OBJECTIVE: To study the association of second-generation antipsychotic medications with body composition and metabolic parameters in patients without prior antipsychotic medication exposure. DESIGN, SETTING, AND PATIENTS: Nonrandomized Second-Generation Antipsychotic Treatment Indications, Effectiveness and Tolerability in Youth (SATIETY) cohort study, conducted between December 2001 and September 2007 at semi-urban, tertiary care, academic inpatient and outpatient clinics in Queens, New York, with a catchment area of 4.5-million individuals. Of 505 youth aged 4 to 19 years with 1 week or less of antipsychotic medication exposure, 338 were enrolled (66.9%). Of these patients, 272 had at least 1 postbaseline assessment (80.5%), and 205 patients who completed the study (60.7%). Patients had mood spectrum (n = 130; 47.8%), schizophrenia spectrum (n = 82; 30.1%), and disruptive or aggressive behavior spectrum (n = 60; 22.1%) disorders. Fifteen patients who refused participation or were nonadherent served as a comparison group. INTERVENTION: Treatment with aripiprazole, olanzapine, quetiapine, or risperidone for 12 weeks. MAIN OUTCOME MEASURES: Weight gain and changes in lipid and metabolic parameters. RESULTS: After a median of 10.8 weeks (interquartile range, 10.5-11.2 weeks) of treatment, weight increased by 8.5 kg (95% confidence interval [CI], 7.4 to 9.7 kg) with olanzapine (n = 45), by 6.1 kg (95% CI, 4.9 to 7.2 kg) with quetiapine (n = 36), by 5.3 kg (95% CI, 4.8 to 5.9 kg) with risperidone (n = 135), and by 4.4 kg (95% CI, 3.7 to 5.2 kg) with aripiprazole (n = 41) compared with the minimal weight change of 0.2 kg (95% CI, -1.0 to 1.4 kg) in the untreated comparison group (n = 15). With olanzapine and quetiapine, respectively, mean levels increased significantly for total cholesterol (15.6 mg/dL [95% CI, 6.9 to 24.3 mg/dL] P < .001 and 9.1 mg/dL [95% CI, 0.4 to 17.7 mg/dL] P = .046), triglycerides (24.3 mg/dL [95% CI, 9.8 to 38.9 mg/dL] P = .002 and 37.0 mg/dL [95% CI, 10.1 to 63.8 mg/dL] P = .01), non-high-density lipoprotein (HDL) cholesterol (16.8 mg/dL [95% CI, 9.3 to 24.3 mg/dL] P < .001 and 9.9 mg/dL [95% CI, 1.4 to 18.4 mg/dL] P = .03), and ratio of triglycerides to HDL cholesterol (0.6 [95% CI, 0.2 to 0.9] P = .002 and (1.2 [95% CI, 0.4 to 2.0] P = .004). With risperidone, triglycerides increased significantly (mean level, 9.7 mg/dL [95% CI, 0.5 to 19.0 mg/dL]; P = .04). Metabolic baseline-to-end-point changes were not significant with aripiprazole or in the untreated comparison group. CONCLUSIONS: First-time second-generation antipsychotic medication use was associated with significant weight gain with each medication. Metabolic changes varied among the 4 antipsychotic medications.

Clinically significant adverse events from a drug interaction between quetiapine and atazanavir-ritonavir in two patients.

Pharmacotherapy. 2009 Nov; 29(11): 1386-91
Pollack TM, McCoy C, Stead W
Clinicians caring for patients infected with the human immunodeficiency virus (HIV) and diagnosed with psychiatric comorbidities must be aware of potential drug-drug interactions, particularly with protease inhibitor-based antiretroviral therapy. Although possible interactions can be predicted based on a drug's pharmacokinetic parameters, the clinical significance is often unknown. We describe two patients who experienced serious quetiapine adverse effects potentially mediated through an interaction with ritonavir-boosted atazanavir. The first patient was a 57-year-old man with HIV and bipolar disease who developed rapid and severe weight gain when quetiapine was added to a stable atazanavir-ritonavir-based antiretroviral regimen. After the patient discontinued both quetiapine and ritonavir, his weight returned to its baseline value. The second patient was a 32-year-old woman with HIV, anxiety disorder, and a history of intravenous drug abuse who developed increased sedation and mental confusion when an atazanavir-ritonavir-based antiretroviral regimen was added to her stable antianxiety drug regimen, which included quetiapine. Her symptoms resolved promptly after discontinuation of the quetiapine. Use of the Naranjo adverse drug reaction probability scale indicated that the adverse effects experienced by the two patients were possibly related and probably related, respectively, to an interaction between quetiapine and atazanavir-ritonavir. Quetiapine is primarily metabolized by cytochrome P450 (CYP) 3A4, and ritonavir is a potent inhibitor of CYP3A4. Thus, it is reasonable to theorize that quetiapine concentrations will increase when these drugs are used concurrently, which would be the likely cause of the toxicities in these two patients. To our knowledge, these are the first published reports of a clinically significant interaction between atazanavir-ritonavir and quetiapine. Clinicians should be aware of the potential for this interaction, and extreme caution should be used when prescribing quetiapine and other atypical antipsychotic agents in HIV-positive patients who are receiving antiretroviral therapy.

 

This page was last reviewed by Dr Greg Mulhauser, Monday, 1 June 2009.

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