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Clinical data

Mauri et al. The review reviewed randomized clinical trials (RCTs) and open trials over the past 13 years that examined the efficacy of quetiapine in depression as monotherapy or in combination with other drugs.In a study by Sajatovic et al. (2002) compared the efficacy and safety of quetiapine and risperidone for the treatment of psychosis in patients on an outpatient basis. The study was a multicenter, open, randomized duration of 4 months. The patients were divided into two groups, in which 554 patients took quetiapine and 175 patients received risperidone. Both drugs had a flexible dosage regimen; the average doses at the 16th week of the study were 318? Mg of quetiapine and 4.4? Mg of risperidone.

Improvement on the Hamilton scale for assessing depression (HAM-D) was observed in both groups, however, patients treated with quetiapine had better results (p = 0.0015), which suggests that the drug is effective for treating the symptoms of depression in patients with psychosis. Calabrese et al. (2005) studied the efficacy of quetiapine for the treatment of depression in BAR. The study involved 542 patients with BAR I (n = 360) and II (n = 182) types who were randomized to quetiapine (300-600? Mg / day) and placebo groups.

Quetiapine at a higher dosage showed a statistically significant improvement in the total score on the Montgomery-Asberg scale (MADRAS), compared with placebo, starting from the first week of treatment. At the end of the study, the percentage of patients who responded to treatment in the quetiapine groups (300 and 600? Mg / day) was 58.2% and 57.6%, respectively, compared to 36.1% in the placebo group. 52.9% of patients from the quetiapine group received remission (MADRAS? 12), compared with 28.4% in the placebo group.

Thus, the efficacy and safety of quetiapine monotherapy in bipolar depression has been demonstrated.In 2006? Hirschfeld et al. conducted a study that examined the effects of quetiapine monotherapy on anxiety symptoms in bipolar depression. The study involved 539 individuals with BAR I (n = 358) and BAR II (n = 181) types. The patients were divided into the quetiapine group (300-600? Mg / day) and placebo.

Persons taking both dosages of the drug showed a significant improvement in the total number of points on the Hamilton Anxiety Anxiety Score (HAM-A) compared with placebo (p <0.001). In patients with type I BAR, the drug reduced anxiety and tension on the HAM-A scale, its mental and somatic subscales, as well as indicators of the internal tension of the MADRS scale, points of mental (but not somatic) anxiety on the HAM-D scale (p <0.001). In patients with type II BAR, the use of quetiapine provoked an increase in anxiety scores on the HAM-A scale, internal tension on the MADRS scale and mental anxiety on the HAM-D scale (p <0.01).

At the end of the study, the authors concluded that monotherapy with quetiapine for the treatment of symptoms of anxiety with type I BAR is quite effective, as well as the need to further study the effect of the drug on patients with type II BAR.The purpose of the study Milev et al. (2006) was to study the long-term efficacy and safety of quetiapine, which was used as an additional therapy in patients with bipolar depression at a dosage of at least 400? Mg / day. According to the data obtained at the end of the study, patients showed a decrease in indicators on the HAM-D scale from 27.2 to 12.1 and on the general clinical impression scale (CGI) from 4.7 to 2.

Thus, the authors concluded that the drug is well tolerated and gives an additional advantage when it is added to the treatment regimen for patients with bipolar depression. In a RCT conducted by Endicott et al. (2007) with the participation of 542 patients with type I and II BAR, the effect of Quetiapine monotherapy at a dosage of 300-600? Mg / day on the quality of life of patients was evaluated. It was found that taking both dosages significantly improved the quality of life of patients compared with placebo, starting from the 4th week until the end of the study (8th week). Also, the drug improved the quality of sleep compared with placebo.

According to the authors, since an improvement in the quality of life can increase patient adherence to treatment, this indicator should be taken into account when conducting further clinical studies in patients with bipolar depression. Baune et al. (2007) studied the effectiveness of combination therapy with antidepressants (venfalaxine, escitalopram) and quetiapine with a flexible dosing regimen for MDD, with an emphasis on such indicators as physical activity, daytime sleepiness and sleep quality.

The authors concluded that quetiapine has an independent positive effect on the symptoms of depression, motor activity, and sleep, and its combination with antidepressants can optimize the treatment of symptoms of depression. Vieta et al. (2007) investigated the efficacy and safety of quetiapine monotherapy in patients with BAR type I and II with rapid phase change.

Quetiapine at a dosage of 300-600? Mg / day significantly improved performance on the MADRS scales (p <0.001), HAM-D, HAM-A, as well as the Pittsburgh sleep quality questionnaire (PSQI) and the questionnaire on life quality satisfaction. Thus, Quetiapine monotherapy has proven to be effective and safe for short-term use in patients suffering from rapid phase change BAR.

The efficacy and safety of quetiapine monotherapy for symptoms of depression in patients with type II BAR have been studied by Suppes et al. (2010). They conducted a retrospective analysis of data obtained from two 8-week RCTs. The primary evaluation criterion was the change in the total score on the MADRS scale from baseline. Taking quetiapine at a dosage of 300? Mg / day (n = 107) and 600? Mg / day (n = 106) showed a significant improvement compared with placebo (n = 108) starting from the first week until the end of the study.

There was also a positive trend in performance on the HAM-D, HAM-A and CGI scales. In general, the results of this retrospective analysis suggest that quetiapine monotherapy is more effective than placebo for the treatment of acute depressive episodes in patients with type II BAR.

A similar study was conducted by Weisler et al. (2008), which assessed the effectiveness of quetiapine monotherapy for depressive episodes in patients with type I BAR. This publication was a retrospective analysis of the BipOLar DEpRession (BOLDER) study. In the combined cohort of patients with episodes of depression with type I BAR, treatment with quetiapine significantly improved the MADRS score compared with placebo from the first week to the end of the study (week 8).In 2010? in another 8-week RCT, Suppes et al. (2010) evaluated the effectiveness of the XR form of quetiapine in bipolar depression.

Patients were randomized to receive 300? Mg of quetiapine XR (n = 133) or placebo (n = 137). The average change in the total score on the MADRS scale at week 8 of the study was -17.4 in the quetiapine XR group; -11.9 in the placebo group (p <0.001). The percentage of responders to treatment (? 50?% Reduction in the total score on the MADRS scale) and reached remission (total score on the MADRS scale? 12) was significantly higher in the quetiapine group than in the placebo group. Since quetiapine XR reduced the level of manifestation of key symptoms of depression, the authors concluded that quetiapine is effective in this form of release for the treatment of acute depressive episodes with BAR.In a study by Young et al. (2013) compared the efficacy and safety of quetiapine and lithium monotherapy for a major depressive episode with BAR compared with placebo.

The average change in the total score on the MADRS scale at the 8th week of the study was -15.4 in the quetiapine group at a dose of 300? Mg / day and -6.1 at a dose of 600? Mg / day, -13.6 – lithium and -11.8 – placebo. Quetiapine at a dosage of 600? Mg / day was statistically significantly more effective than lithium and reduced the total score on the MADRS scale. Also in patients in the quetiapine group, an improvement was noted in comparison with placebo on the HAM-D, CGI and HAM-A scales.

The authors concluded that quetiapine at 300 and 600? Mg / day is more effective than placebo for the treatment of acute depressive episodes with BAR. Lithium showed no statistically significant differences in key indicators compared with placebo.Mc Elroy et al. (2010) studied the efficacy and safety of quetiapine and paroxetine monotherapy in a major depressive episode in patients with BAR.

The average change in the total score on the MADRS scale on the 8th week of the study was -16.19 points when taking quetiapine at a dose of 300? Mg / day and -16.31 at a dose of 600? Mg / day, -13.76 – paroxetine and -12,60 – for placebo. Quetiapine in both dosages showed a more pronounced improvement on the MADRS and HAM-D scales than paroxetine.

The incidence of mania / hypomania during treatment was lower in the quetiapine group than in the paroxetine and placebo groups.The purpose of the study is Ketter et al. (2010) evaluated the effectiveness of quetiapine administered to patients in medical institutions for the treatment of symptoms of BAR. The average duration of Quetiapine treatment was 385 days, and the average daily dose was 196? Mg / day (half of the patients took 75? Mg / day). In 38.5% of patients, the duration of quetiapine intake was on average 328 days without additional psychotropic therapy. In 22.9% therapy lasted an average of 613 days, and at the same time, after 113 days, there was a need for an additional drug, often to relieve the symptoms of depression.

Apart from sedation, quetiapine was well tolerated by patients. The authors concluded that the data obtained – a moderate (38.5?% After 385 days) percentage of quetiapine withdrawal at the outpatient stage and the absence of the need for an additional drug – may indicate its effectiveness in patients in medical institutions.Weisle et al. (2008) analyzed the efficacy and safety of maintenance treatment with quetiapine compared with switching to lithium or placebo in patients with type I BAR. Patients with an established diagnosis of Type I BAR and a recent episode of mania, depressive or mixed episodes received 300-800? Mg / day of quetiapine for 4-24 weeks. After stabilization, patients were randomly assigned to quetiapine, placebo or lithium groups (0.6-1.2 meq / l).

Of the 2438 patients who completed the open phase, 1226 (50.3%) were included in the second double-blind phase of the study. The time before the onset of relapse of any of the affective episodes was significantly longer in the quetiapine and lithium groups than in the placebo group (p <0.0001). In patients whose condition stabilized when taking quetiapine, supportive therapy was statistically significantly more effective in preventing episodes of mania, depression, and other affective episodes compared with placebo.

Supportive lithium therapy has also been effective in preventing episodes of mania and depression.Kim et al. (2014) in an 8-week study compared the efficacy of quetiapine XR monotherapy and lithium in patients with symptoms of depression and sleep disorders in 42 patients with bipolar depression. In both groups, there was an improvement on the HAM-D scale, however, the percentage of remissions in the Quetiapine XR group was significantly higher than in the lithium group. There was also a significant improvement in PSQI at the 1st, 2nd, 4th, 6th, and 8th weeks of the study, as well as the effectiveness of sleep at the 6th and 8th weeks.

In addition, the number of awakening episodes after falling asleep at week 8 has decreased. Based on the findings, the authors concluded that quetiapine XR monotherapy for depression symptoms with BAR is more effective than lithium monotherapy, and that quetiapine XR treatment improves the subjective and objective sleep quality indicators in patients with bipolar depression.

Safety and Portability

As noted by Mauri et al., Quetiapine was generally well tolerated by patients.

In the majority of studies, participants did not experience significant weight gain, however, they were sometimes encountered in clinical practice. No extrapyramidal or anticholinergic side effects have been reported.Mc Elroy et al. (2010) in a double-blind, placebo-controlled study compared the efficacy and safety of quetiapine and paroxetine monotherapy in a major depressive episode in patients with BAR.

The most frequent side effects in the quetiapine groups (300 and 600? Mg) were dry mouth, drowsiness, sedation and dizziness, and in the paroxetine group: dryness ort, sedation, headache, insomnia and vomiting.In the quetiapine groups, the incidence of mania / hypomania during treatment was lower than in paroxetine and placebo groups. More significant weight gain occurred in both groups of quetiapine (9 and 11?%, Respectively) than in the paroxetine (3?%) Or placebo (4?%) Groups.

With regard to laboratory parameters, quetiapine did not cause any significant changes during the 8 weeks of the study, however, compared with baseline, there was a more pronounced fluctuation in triglyceride and insulin levels in the quetiapine and placebo groups than in the paroxetine group.

Findings

Quetiapine is a multifunctional drug due to its ability to modify noradrenergic, serotonergic, and dopaminergic neurotransmission. These effects are mediated by both the main active ingredient and the active metabolite, norkvetiapin.

According to the authors, monotherapy with quetiapine acute bipolar depression has advantages over antidepressants in terms of preventing phase transitions. Evidence of the efficacy of quetiapine monotherapy provides grounds for treating it as a first-line drug for the treatment of the acute phase and maintenance therapy for bipolar depression.