MXPA06008131A - Treatment of psychoses with quetiapine antipsychotic - Google Patents
Treatment of psychoses with quetiapine antipsychoticInfo
- Publication number
- MXPA06008131A MXPA06008131A MXPA/A/2006/008131A MXPA06008131A MXPA06008131A MX PA06008131 A MXPA06008131 A MX PA06008131A MX PA06008131 A MXPA06008131 A MX PA06008131A MX PA06008131 A MXPA06008131 A MX PA06008131A
- Authority
- MX
- Mexico
- Prior art keywords
- quetiapine
- depression
- bipolar
- patient
- disorder
- Prior art date
Links
- 238000011282 treatment Methods 0.000 title claims description 43
- 229960004431 quetiapine Drugs 0.000 title claims description 39
- URKOMYMAXPYINW-UHFFFAOYSA-N quetiapine Chemical compound C1CN(CCOCCO)CCN1C1=NC2=CC=CC=C2SC2=CC=CC=C12 URKOMYMAXPYINW-UHFFFAOYSA-N 0.000 title claims description 36
- 208000028017 Psychotic disease Diseases 0.000 title description 2
- 230000000561 anti-psychotic effect Effects 0.000 title description 2
- 208000020925 Bipolar disease Diseases 0.000 claims abstract description 37
- 238000000034 method Methods 0.000 claims abstract description 33
- 208000024891 symptom Diseases 0.000 claims abstract description 22
- 208000028683 bipolar I disease Diseases 0.000 claims description 21
- 206010026749 Mania Diseases 0.000 claims description 19
- 208000019022 Mood disease Diseases 0.000 claims description 13
- 150000003839 salts Chemical class 0.000 claims description 12
- ABFPKTQEQNICFT-UHFFFAOYSA-M 2-chloro-1-methylpyridin-1-ium;iodide Chemical group [I-].C[N+]1=CC=CC=C1Cl ABFPKTQEQNICFT-UHFFFAOYSA-M 0.000 claims description 11
- 229960005197 quetiapine fumarate Drugs 0.000 claims description 11
- 208000019901 Anxiety disease Diseases 0.000 claims description 6
- 230000036506 anxiety Effects 0.000 claims description 6
- 239000003814 drug Substances 0.000 claims description 6
- 150000001875 compounds Chemical class 0.000 claims description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 5
- 239000000935 antidepressant agent Substances 0.000 claims description 4
- 229940005513 antidepressants Drugs 0.000 claims description 4
- 208000022257 bipolar II disease Diseases 0.000 claims description 4
- -1 quetiapine compound Chemical class 0.000 claims description 4
- 238000011294 monotherapeutic Methods 0.000 claims description 3
- 230000003860 sleep quality Effects 0.000 claims description 3
- 230000001430 anti-depressive effect Effects 0.000 claims description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims 1
- 125000001301 ethoxy group Chemical group [H]C([H])([H])C([H])([H])O* 0.000 claims 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims 1
- 208000025307 bipolar depression Diseases 0.000 description 19
- 229940068196 placebo Drugs 0.000 description 14
- 239000000902 placebo Substances 0.000 description 14
- 208000020401 Depressive disease Diseases 0.000 description 9
- 230000000694 effects Effects 0.000 description 4
- 230000006872 improvement Effects 0.000 description 4
- 208000024714 major depressive disease Diseases 0.000 description 4
- 238000009097 single-agent therapy Methods 0.000 description 4
- 206010002869 Anxiety symptoms Diseases 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- XGZVUEUWXADBQD-UHFFFAOYSA-L lithium carbonate Chemical compound [Li+].[Li+].[O-]C([O-])=O XGZVUEUWXADBQD-UHFFFAOYSA-L 0.000 description 3
- 229910052808 lithium carbonate Inorganic materials 0.000 description 3
- 208000027776 Extrapyramidal disease Diseases 0.000 description 2
- 206010021030 Hypomania Diseases 0.000 description 2
- 230000001133 acceleration Effects 0.000 description 2
- 230000004913 activation Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 230000036651 mood Effects 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 235000017647 Brassica oleracea var italica Nutrition 0.000 description 1
- 244000308180 Brassica oleracea var. italica Species 0.000 description 1
- 206010012374 Depressed mood Diseases 0.000 description 1
- 206010054089 Depressive symptom Diseases 0.000 description 1
- 102000003946 Prolactin Human genes 0.000 description 1
- 108010057464 Prolactin Proteins 0.000 description 1
- 201000001880 Sexual dysfunction Diseases 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 230000003556 anti-epileptic effect Effects 0.000 description 1
- 239000001961 anticonvulsive agent Substances 0.000 description 1
- YAZBBWJDISBOAL-UHFFFAOYSA-N benzo[d][1,2]benzothiazepine Chemical compound S1N=CC2=CC=CC=C2C2=CC=CC=C12 YAZBBWJDISBOAL-UHFFFAOYSA-N 0.000 description 1
- 238000012217 deletion Methods 0.000 description 1
- 230000037430 deletion Effects 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 150000008509 dibenzothiazepines Chemical class 0.000 description 1
- 239000003937 drug carrier Substances 0.000 description 1
- 201000003104 endogenous depression Diseases 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- PYZRQGJRPPTADH-UHFFFAOYSA-N lamotrigine Chemical compound NC1=NC(N)=NN=C1C1=CC=CC(Cl)=C1Cl PYZRQGJRPPTADH-UHFFFAOYSA-N 0.000 description 1
- 229960001848 lamotrigine Drugs 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 238000001050 pharmacotherapy Methods 0.000 description 1
- 238000002203 pretreatment Methods 0.000 description 1
- 229940097325 prolactin Drugs 0.000 description 1
- 238000012797 qualification Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 231100000872 sexual dysfunction Toxicity 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- MSRILKIQRXUYCT-UHFFFAOYSA-M valproate semisodium Chemical compound [Na+].CCCC(C(O)=O)CCC.CCCC(C([O-])=O)CCC MSRILKIQRXUYCT-UHFFFAOYSA-M 0.000 description 1
- 229960000604 valproic acid Drugs 0.000 description 1
- 230000004584 weight gain Effects 0.000 description 1
- 235000019786 weight gain Nutrition 0.000 description 1
Abstract
The present invention provides methods for treating depression symptoms associated with bipolar disorder.
Description
TREATMENT OF PSYCHOSIS WITH THE ANTIPSICOTIQUE QUETIAPINA
FIELD OF THE INVENTION The present invention relates to methods using an antipsychotic dibenzothiazepine. BACKGROUND OF THE INVENTION Bipolar disorders are disorders in mood in which a predominant feature is an alteration in mood. 'Bipolar disorder I is characterized by one or more manic or mixed episodes, usually accompanied by major depressive episodes.
Bipolar II disorder is characterized by one or more major depressive episodes accompanied by at least one hypo-anic episode. Bipolar depression refers to major depressive episodes that occur with bipolar I and II. It is estimated that the prevalence of bipolar disorder is from 1 to 3.5%, divided evenly between men and women. The duration of time between onset and symptoms and an adequate diagnosis in the treatment is approximately 10 years. It is estimated that only 60% of people with bipolar disorder receive appropriate pharmacotherapy. Although there is extensive and growing literature that via the treatment of the manic phase of the disorder - And Ref. 174310 Bipolar I as well as many compounds approved for the treatment of unipolar depression, the treatment of bipolar depression has not been studied extensively and the lines of guidance for the treatment are in their infancy. The use of antidepressants currently available for monotherapy for bipolar depression are often problematic since they can increase "activation" in hypomania or mania from depression or increase the acceleration of the cycle. In addition, patients may experience hobbies that arise with treatment with antidepressant monotherapy. The "joint use of mood-stabilizing drugs such as lithium carbonate (LiC03) is common and may decrease the likelihood of these complications." The evidence indicates that drugs with mood-stabilizing properties, which produce low levels of mania, hypomania or Cycle acceleration may be useful as monotherapy in the treatment of bipolar depression The antiepileptic lamotrigine produces improvements in the HAM-D and MADRS ratings in a 7-week, double-blind, placebo-controlled trial for patients who completed this study (Calabrese 1999). More recently, the antimalar agent divalproex demonstrated numerical improvement over placebo in a percentage of patients with bipolar depression who had a 50% reduction in HAM-D ratings without mania in 8-week trials (Sachs, 2001) but This difference is not statistically significant, it has been shown that lithium carbonate, also n approved for the treatment of mania, it is effective as a monotherapeutic agent in approximately 50% of patients with bipolar depression (Bauer). However, there are limitations regarding the use of previous treatments. DETAILED DESCRIPTION OF THE INVENTION Quetiapine fumarate was described in the patent of E.U.A. No. 4,879,288, which is incorporated herein by reference. Quetiapine fumarate (quetiapine) is a derivative of dibenzothiazepine and is chemically referred to as 2- [2- (4-dibenzo [b, f] [1,4] thiazepin-11-yl-l-piperazinyl) ethoxy fumarate ] ethanol However, the applicants have achieved surprising results that indicate the success of quetiapine in treating depression states. Recent clinical studies have shown pharmacological properties, previously unrecognized, that suggest that quetiapine is useful in the treatment of depression associated with bipolar disorder. In addition, quetiapine has been found to be well tolerated in the treatment of bipolar depression with a low incidence of extrapyramidal symptoms (EPS), prolactin, sexual dysfunction and weight gain. Additionally, quetiapine is not related to the mania that arises from treatment, in the treatment of bipolar depression and the treatment that results in a low rate of mania that arises with treatment.
It has now been discovered that quetiapine or a pharmaceutically acceptable salt thereof is an effective treatment of depression symptoms related to one or more mood disorders. . • - - Some embodiments of the invention include a method of treating symptoms of depression related to one or more mood disorders comprising administering to a patient a therapeutically effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound of formula ( I):
Some embodiments of the method include the use of a quetiapine compound or a pharmaceutically acceptable salt thereof, for the preparation of a medicament for treating symptoms of. depression related to one more mood disorders in a patient. Other modalities of the method include the use of a quetiapine compound or a pharmaceutically acceptable salt thereof, for the preparation of a medicament for treating symptoms of depression related to bipolar disorder in a patient.
The present invention relates to a method for treating one or more mood disorders by administering quetiapine. In formula I the structure of quetiapine is shown:
One embodiment of the invention provides a method which comprises administering quetiapine or a pharmaceutically acceptable salt to a patient, for the treatment of symptoms of depression related to one or more mood disorders. Another embodiment of the invention provides a method which comprises administering quetiapine fumarate to a patient for the treatment of depression symptoms related to bipolar disorder. Another embodiment of the invention provides a method which comprises administering quetiapine fumarate to a patient for the treatment of depression symptoms related to bipolar disorder I. Another embodiment of the invention provides a method which comprises administering quetiapine fumarate to a patient for the treatment of depression symptoms related to bipolar II disorder.
Another embodiment of the invention provides a method which comprises administering quetiapine fumarate to a patient for the treatment of depression symptoms related to bipolar depression. The term "therapeutically effective amount" as used herein means an amount of the compound which is effective to treat the disorder or condition mentioned. In one embodiment, bipolar depression can be treated by administering quetiapine to a patient in a dosage ranging from about 300 mg / day to about 600 mg / day. Applicants have found that quetiapine is more effective than placebo and is well tolerated for the treatment of depressive episodes in patients with one or more mood disorders. Applicants have also found that quetiapine is more effective than placebo and is well tolerated for the treatment of depressive episodes in patients with bipolar depression. In addition, quetiapine is more effective than placebo and is well tolerated for the treatment of anxiety symptoms, reduced quality of sleep and reduced quality of life in patients with bipolar disorder. The following examples that are provided in no way limit the invention in any way and are intended to be for illustrative purposes only. EXAMPLES The results of a monotherapy study demonstrate the therapeutic value of the use of quetiapine fumarate in the treatment of patients with bipolar depression. Study The study is a randomized, placebo-controlled, double-blind, double-blind, multi-center trial using quetiapine fumarate in the treatment of patients with bipolar depression performed in 539 subjects with 511" Patients in an ITT population Treatment is quetiapine or placebo, 43% of the patients are male and 57% of the female gender, Demographic data also include 67% of patients with bipolar disorder and 33% with bipolar II Some of the key inclusion criteria are: Fulfill the DSM-IV criteria for bipolar I disorder or bipolar II disorder, the most recent episode of depression (296.5x and 296.89x), confirmed by a structured clinical interview, modified for DMS -IV (SCID); (2) a current episode of depression > 4 weeks; some of the key exclusion criteria are: in the screening and initial values: a total HAMD-D rating (17 items) > twenty; a HAM-D qualification subsection 1 (depressed mood) > 2; pre-treatment with an adequate course of more than 2 antidepressants for your current-episode or treatment for more than 12 months; > 12 in the YMRS (that is, non-mixed episodes); current (or in the last 6 months) of axis I disorder different from bipolar disorder. Dosage Quetiapine is titrated in a manner that the investigators do not know if it is quetiapine or placebo, at a total daily dose of approximately 300 mg / day on day 4 in the treatment group of 300 mg / day or a daily dose total of approximately 600 mg / day on day 8, in a treatment group of 600 mg / day. Subsequently, oral doses of quetiapine fumarate were administered in a manner to avoid biases, once a day in a total daily dose of approximately 300 or approximately 600 mg / day.
TITULATION PROTOCOL Dosing group DAY
The primary endpoints were determined by MADRS (Montgomery / Asberg Depression Rating Scale (MADRS) with change from initial value to final determination.) Secondary endpoints evaluated by HAM-D (Hamilton Rating Scale for anxiety), CGI-S (clinical global impression severity), CGI-C (global clinical impression change) and the change from the initial values, the incidence of mania that arises with the treatment, compared with placebo, effect of quetiapine on the anxiety and safety and tolerability of quetiapine in the treatment of patients with bipolar depression The exploratory endpoints include quetiapine efficacy on sleep quality (determined through the Pittsburgh Sleep Quality Index) PSQI)), efficacy of quetiapine in the general quality of life (through the questionnaire of enjoyment and satisfaction of quality of life (Q-Les-Q , short form.) Results Changes in MADRS, bipolar I and II (ITT population (attempt to treat)
Results MADRS / HAM-D-: ITT and populations that completed (PLA = Placebo)
Q-LES-Q-Week 4 and 8
* P < 0.001; aP < 0.05
PSQ1- Week 4 and 8
* P < 0.001; LOCF: Sent by bearer of the last observation
Efficacy Summary Effectiveness against depressive symptoms in both doses from day 8 onwards (p <0.001) (MADRS and HAM-D). 20% advantage over placebo for the analysis of respondents to MADRS; effect size of MADRS 0.6 (bipolar I and II); 20% advantage over placebo in the remission analysis; MADRS effect size: 0.6 (bipolar I and II). Efficacy in anxiety symptoms (HAM-A) in both doses from day 8 onwards (p <0.01). Clinical improvement (CGI) in both doses from day 8 onwards (p <0.001). Significant results in the final analyzes reported of the patients (PSQI and Q-LES-Q).
Mania arising from treatment The criterion for emergent mania (any of the following): AE (adverse event) or SAE (serious adverse event) of mania. Withdrawal by AE of mania. YMRS (Young mania classification scale) > 16 in 2 consecutive or final detentions. These results suggest that quetiapine is not associated with mania arising from treatment ("activation") in the treatment of bipolar depression. 600 mg 300 mg - Placebo 4 (2.4%) 6 (3.5%) 7 (4.1%) Quetiapine was also found to be effective in a wide range of symptom domains in bipolar depression, including anxiety and reduced quality of dream . Dream Week 8 LOCF
Anxiety Mean values of anxiety measured by the HAM-A score with similar groups through the treatments: 18-6-18.9. Patients who took quetiapine approximately 300 and approximately 600 rrtgVal day showed a significant improvement (P <0.05) higher in the mean HAM-A score versus placebo in each determination beginning with the first evaluation (day 8) and sustained through the point final (week 8) (-8.6 and -8.7 versus -5.5). Safety Summary There are no unexpected AE trends: low emerging mania rate; comparable across all groups; there is no statistical difference in completion rates, dose-related trends, increased suppressions for AE, reduction in deletions for lack of effect; small changes related to doses in weight. Consequently, quetiapine was found to be safe and effective for the treatment of bipolar depression, effective in the treatment of anxiety symptoms related to bipolar depression, efficacy in improving the quality of life and quality of sleep in patients with bipolar depression. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.
Claims (23)
1. A method for treating the symptoms of depression of one or more mood disorders in a patient, characterized in that it comprises administering to a patient a therapeutically effective amount of quetiapine or a pharmaceutically acceptable salt thereof.
2. The method according to claim 1, characterized in that the pharmaceutically acceptable salt of quetiapine is quetiapine fumarate.
3. The method according to claim 1, characterized in that the symptom of depression is anxiety.
4. The method according to claim 1, characterized in that the symptom of depression is reduced sleep quality.
5. The method according to claim 1, characterized in that the symptom of depression is reduced quality of life.
6. The method according to claim 1, characterized in that quetiapine is administered at a dose from about 300 mg / day to about 600 mg / day for a patient.
The method according to claim 1, characterized in that quetiapine is administered at a dose of approximately 300 mg / day.
8. The method according to claim 1, characterized in that quetiapine is administered at a dose of approximately 600 mg / day.
9. The method according to claim 1, characterized in that quetiapine is administered once a day.
10. The method according to claim 1, characterized in that the amount of quetiapine results in a low rate of mania arising from the treatment.
11. The method according to claim 1, characterized in that the mood disorder is bipolar disorder.
12. The method according to claim 11, characterized in that the mood disorder is bipolar I disorder.
13. The method according to claim 11, characterized in that the mood disorder is bipolar II disorder.
A method for treating depression symptoms of bipolar disorder, characterized in that it comprises: administering to a patient a therapeutically effective amount of a compound of formula (I): or a pharmaceutically acceptable salt thereof.
15. The method according to claim 14, characterized in that the pharmaceutically acceptable salt of quetiapine is quetiapine fumarate.
16. A monotherapeutic method for treating a patient by the symptoms of depression of one or more mood disorders, characterized in that it comprises administering to the patient a therapeutically effective amount of quetiapine or a pharmaceutically acceptable salt thereof.
17. The method according to claim 16, characterized in that the mood disorder is bipolar disorder.
18. The method according to claim 16, characterized in that the bipolar disorder is bipolar I.
19. The method according to claim 16, characterized in that the bipolar disorder is bipolar II.
20. A monotherapeutic method of treating a patient for the symptoms of depression of bipolax disorder, characterized in that it comprises administering to the patient a therapeutically effective amount of 2 - [2- (4-dibenzo [b, f] [1, 4] fumarate ] thiazepin-11-yl-1-piperazinyl) ethoxy] ethanol.
21. A method of treating symptoms of depression characterized in that a patient is administered an antidepressant amount of a compound that is selected from quetiapine and a pharmaceutically acceptable salt thereof.
22. The use of a quetiapine compound or a pharmaceutically acceptable salt thereof, for the preparation of a medicament for the treatment of symptoms of depression associated with one or more mood disorders in a patient.
23. The use of a quetiapine compound or a pharmaceutically acceptable salt thereof for the preparation of a medicament for the treatment of symptoms of depression associated with bipolar disorder in a patient.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US60/540,618 | 2004-01-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MXPA06008131A true MXPA06008131A (en) | 2006-12-13 |
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