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):

A randomized controlled trial of quetiapine for psychosis in Parkinson's disease.

Neuropsychiatr Dis Treat. 2009; 5: 327-32
Shotbolt P, Samuel M, Fox C, David AS
INTRODUCTION: Psychosis (delusions and/or hallucinations) is a well-recognized complication of treatment of Parkinson's disease (PD). Quetiapine is a currently favored treatment, but data on its efficacy are equivocal. This trial aimed to provide further evidence on the efficacy of quetiapine in PD psychosis. METHODS: We conducted a 12 week double blind randomized placebo-controlled trial. Time to dropout due to lack of improvement of psychosis was the primary outcome measure. Other important secondary outcomes were evaluated using standard rating scales for PD and psychiatric symptoms. RESULTS: Twenty-four eligible subjects gave consent. The primary outcome, time to dropout, was examined using survival analysis. It was shown that patients in the quetiapine group dropped out earlier than those in the placebo group, but this difference was not significant (p = 0.68). No significant changes were found for any of the secondary outcome measures in either group. CONCLUSIONS: In this study, quetiapine at doses of up to 150 mg/day failed to significantly improve psychosis compared to placebo, however the small sample size does not allow any conclusive interpretation of the results. Quetiapine did not appear to worsen PD motor functioning, but its use was limited by a faster drop out compared with placebo. Significant impediments were difficulty with recruitment and natural fluctuation in symptoms during the trial.

Effectiveness of second-generation antipsychotics with acute-phase schizophrenia.

Schizophr Res. 2009 Jun 22;
Hatta K, Sato K, Hamakawa H, Takebayashi H, Kimura N, Ochi S, Sudo Y, Asukai N, Nakamura H, Usui C, Kawabata T, Hirata T, Sawa Y
PURPOSE: Although olanzapine may have advantages over other second-generation antipsychotics (SGAs) regarding longer time to treatment discontinuation among chronically ill patients, little evidence has been provided for the comparative effectiveness of SGAs in the acute phase. We aimed to determine if any of four SGAs were more effective in treating newly admitted acute schizophrenic patients. We performed a rater-blinded, randomized controlled trial of four SGAs in 15 psychiatric emergency sites. Eligible patients were 18-64 years old and met diagnostic criteria for schizophrenia, acute schizophrenia-like psychotic disorder, or schizoaffective disorder. A final total of 78 patients were randomly assigned by means of sealed envelopes to receive risperidone (3-12 mg/day; n=20), olanzapine (10-20 mg/day; n=17), quetiapine (300-750 mg/day; n=20), or aripiprazole (12-30 mg/day; n=21), with follow-up at 8 weeks. The primary outcome measure was all-cause treatment discontinuation. RESULTS: Overall, 37% (29/78) of patients discontinued the study medication before 8 weeks: 25% for risperidone; 12% for olanzapine; 55% for quetiapine; and 52% for aripiprazole. Time to treatment discontinuation for any cause was significantly longer in the olanzapine group than in the quetiapine (p=0.006) or aripiprazole (p=0.008) groups, but not compared to the risperidone group (p=0.32). Time to treatment discontinuation was significantly longer in the risperidone group than in the quetiapine group (p=0.048), but not compared to the aripiprazole group (p=0.062). However, the rate of p.r.n. intramuscular haloperidol use was significantly higher in the aripiprazole group than in other groups (p=0.029). CONCLUSION: Olanzapine and risperidone are superior to quetiapine and aripiprazole for the acute treatment of psychosis in hospitalized patients.

Can a nonequivalent choice of dosing regimen bias the results of flexible dose double blind trials? The CATIE schizophrenia trial.

Schizophr Res. 2009 Jun 20;
Rosenheck RA, Davis VG, Davis SM, Stroup S, McEvoy J, Swartz M, Lieberman J
BACKGROUND: One of the major challenges in the design of double-blind flexible-dosing clinical trials comparing active drugs is the selection of dosing regimens that are equivalent across drugs. This study uses data from the CATIE schizophrenia trial to evaluate the hypothesis that drugs that were dosed somewhat higher in the trial than in typical practice would show greater efficacy and more side effects, especially at high capsule levels, than drugs that were dosed at lower relative strengths. METHODS: CATIE was a large (N=1460) randomized trial comparing 5 antipsychotics in patients with chronic schizophrenia. The blind was maintained in CATIE by prescribing identical-looking capsules of each medication. Dosing was flexible, such that PIs could prescribe from one to four capsules per day, and could modify the dose based on a patient's symptoms and side effects. Capsule strengths for olanzapine (7.5 mg) and quetiapine (200 mg) were relatively higher than for risperidone (1.5 mg), perphenazine (8 mg) or ziprasidone (40 mg). Proportional hazards models of time to all cause discontinuation and mixed regression models for continuous measures of symptoms, quality of life and side effects were used to test for interactions between randomly assigned drug and number of capsules prescribed per visit. We hypothesized that if a dosing bias was present, the flex-dosing design would result in a significant interaction such that drugs with higher relative dosing per capsule would be more effective and have more side effects than drugs with lower relative dosing and that this effect would be greatest at the largest prescribed dosing regimen (4 capsules). RESULTS: There were no significant interactions between drug assignment and number of capsules in the proportional hazards analyses of time to all cause discontinuation (p=.77, excluding ziprasidone and .74 in the ziprasidone cohort) or in the mixed model analysis of PANSS symptoms (p=.49), quality of life (p=.45); or measures of tardive dyskinesia (AIMS, p=.47). However a significant interaction was observed on the Barnes akathisia scale (p=.0005), on the Simpson Angus EPS scale (p=.10) and on the analysis of weight (p=0.014). Paired comparisons did not show the hypothesized pattern of relationships for akathisia or EPS, but such a pattern was suggested for olanzapine in the analysis of weight although it emerged at 2, 3 and 4 capsules indicating a general drug effect rather than a relative dosing difference. CONCLUSION: Dosing biases do not seem to have affected the results of the CATIE trial.

Medicating mood with maintenance in mind: bipolar depression pharmacotherapy.

Bipolar Disord. 2009 Jun; 11 Suppl 2: 55-76
Malhi GS, Adams D, Berk M
OBJECTIVES: Bipolar depression is a core feature of bipolar disorder, a phase in which many patients spend the majority of time and one that confers a significant degree of burden and risk. The purpose of this paper is to briefly review the evidence base for the pharmacotherapy of bipolar depression and to discuss the recommendations for its optimal management. METHODS: A detailed literature review was undertaken with a particular emphasis on pharmacological treatment strategies for bipolar depression across the acute and maintenance phases of the illness. Electronic library and Web-based searches were performed using recognised tools (MEDLINE, PubMED, EMBASE and PsychINFO) to identify the pertinent literature. A summary of the evidence base is outlined and then distilled into broad clinical recommendations to guide the pharmacological management of bipolar depression. RESULTS: Partitioning treatment into acute and maintenance therapy is difficult based on the paucity of current evidence. The evidence from treatment trials favours the use of lithium and lamotrigine as first-line treatment in preference to valproate, and indicates that, for acute episodes, quetiapine and olanzapine have perhaps achieved equivalence at least in terms of efficacy. However, the effectiveness of the atypical antipsychotics in maintenance therapy is constrained by the potential for significant side effects of individual agents and the lack of both long-term research data and clinical experience in treating bipolar disorder as compared to other agents. Conversely, lithium and the anticonvulsants are generally slower to effect symptomatic change, and this limits their usefulness. CONCLUSIONS: There has been a tendency for research trials of bipolar depression to differentiate the illness cross-sectionally into the acute and maintenance phases of bipolar depression; however, in clinical terms, bipolar depression invariably follows a longitudinal course in which the phases of illness are inextricably linked, and useful acute treatments are typically continued in maintenance. Therefore, when medicating mood in acute bipolar depression it is imperative to keep maintenance in mind as it is this aspect of treatment that determines long-term success.

Antipsychotic agents in the treatment of bipolar mania.

Bipolar Disord. 2009 Jun; 11 Suppl 2: 45-54
Tohen M, Vieta E
OBJECTIVES: Antipsychotics have been widely used in the treatment of bipolar mania. The purpose of this manuscript was to briefly review the evidence of typical and atypical antipsychotics for the treatment of bipolar mania. METHODS: A detailed literature review was conducted on the use of typical and atypical antipsychotics in the treatment of bipolar mania using standard search engines. A summary of the published literature on each agent is described followed by a discussion on the overall comparison of the different agents. RESULTS: For typical antipsychotics, up until recently, there was a paucity of published evidence on their strengths and limitations in the treatment of bipolar mania. Recent studies have demonstrated clear evidence on the efficacy of haloperidol on the treatment of acute mania. The literature suggests a faster onset of action of haloperidol as compared to either lithium or atypical antipsychotics. A limitation of typical antipsychotics however, is the risk of tardive dyskinesia, extrapyramidal side effects and a possible increased risk of non-adherence. Evidence on the efficacy for atypical antipsychotics has been demonstrated for aripiprazole, clozapine, olanzapine, quetiapine, risperidone and ziprasidone. Limitations as regards the use of atypical antipsychotics include the risk of weight gain and dyslipidemia. Comparison among different atypical antipsychotics agents are difficult to determine as there are no conclusive head to head studies. There is also a paucity of studies comparing atypical antipsychotics with lithium. CONCLUSIONS: Evidence exists on the efficacy of both typical and atypical antipsychotics on the treatment of acute mania such that they are now clearly first-line along with lithium. An important limitation of the published literature is that most of the studies were designed to obtain regulatory approval for the different agents therefore the generalizability of the findings to clinical practice remains unclear.

 

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

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