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Claims for Patent: 9,387,182

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Claims for Patent: 9,387,182

Title:Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Abstract: The pharmaceutical composition of the present invention comprises (1) a carbostyril derivative and (2) a serotonin reuptake inhibitor in a pharmaceutically acceptable carrier. The carbostyril derivative may be aripiprazole or a metabolite thereof, which is a dopamine-serotonin system stabilizer. The serotonin reuptake inhibitor may be fluoxetine, duloxetine, venlafaxine, milnacipran, citalopram, fluvoxamine, paroxetine, sertraline or escitalopram. The pharmaceutical composition of the present invention is useful for treating patients with mood disorders, particularly depression or major depressive disorder.
Inventor(s): Kikuchi; Tetsuro (Tokushima, JP), Iwamoto; Taro (Princeton, NJ), Hirose; Tsuyoshi (Tokushima, JP)
Assignee: OTSUKA PHARMACEUTICAL CO., LTD. (Tokyo, JP)
Application Number:14/252,907
Patent Claims: 1. A pharmaceutical composition comprising: (a) a compound selected from aripiprazole or a metabolite of aripiprazole, wherein the metabolite of aripiprazole is selected from the group consisting of dehydroaripiprazole, DM-1451 and DM-1452 in combination with (b) at least one serotonin reuptake inhibitor selected from the group consisting of fluoxetine, duloxetine, venlafaxine, milnacipran, citalopram, fluvoxamine, paroxetine, sertraline, escitalopram, and salts thereof.

2. A pharmaceutical composition comprising aripiprazole in combination with at least one serotonin reuptake inhibitor selected from the group consisting of fluoxetine, duloxetine, venlaflaxine, milnacipran, citalopram, fluvoxamine, paroxetine, sertraline and salts thereof.

3. A pharmaceutical composition comprising aripiprazole in combination with at least one serotonin reuptake inhibitor selected from escitalopram or a salt thereof.

4. The composition of claim 2, wherein the at least one serotonin reuptake inhibitor is citalopram.

5. The composition of any one of claims 1, 2, 3 and 4, wherein aripiprazole is anhydrous aripiprazole crystals B.

6. The composition of any one of claims 1, 2, 3 and 4, further comprising at least one pharmaceutically acceptable carrier.

7. The composition of any one of claims 1, 2, 3 and 4, wherein the composition is useful for the treatment of depression or major depressive disorder.

8. The composition of any one of claims 1, 2, 3 and 4, wherein the composition is useful for the treatment of major depressive disorder or dementia with depressive symptoms.

9. The composition of any one of claims 1, 2, 3, and 4, wherein the composition is useful for the treatment of major depressive disorder, endogenous depression, melancholia, depression in combination with psychotic episodes, bipolar disorder with depressive phase, refractory depression, dementia of the Alzheimer's type with depressive symptoms, Parkinson's disease with depressive symptom, senile dementia, mood disorder associated with cerebral blood vessels and mood disorder following head injury.

10. A pharmaceutical composition comprising at least one metabolite of aripiprazole selected from the group consisting of dehydroaripiprazole, DM-1451 and DM-1452 in combination with at least one serotonin reuptake inhibitor selected from the group consisting of fluoxetine, duloxetine, venlafaxine, milnacipran, citalopram, fluvoxamine, paroxetine, sertraline, escitalopram and salts thereof.

11. The composition of claim 10, wherein the at least one serotonin reuptake inhibitor is citalopram.

12. The composition of claim 10, wherein the at least one serotonin reuptake inhibitor is escitalopram.

13. The composition of any one of claims 10 to 12 further comprising at least one pharmaceutically acceptable carrier.

14. The composition of any one of claims 10 to 12 wherein the composition is useful for the treatment of depression or major depressive disorder.

15. The composition of any one of claims 10 to 12, wherein the composition is useful for the treatment of major depressive disorder or dementia with depressive symptoms.

16. The composition of any one of claims 10 to 12, wherein the composition is useful for the treatment of major depressive disorder, endogenous depression, melancholia, depression in combination with psychotic episodes, bipolar disorder with depressive phase, refractory depression, dementia of the Alzheimer's type with depressive symptoms, Parkinson's disease with depressive symptom, senile dementia, mood disorder associated with cerebral blood vessels and mood disorder following head injury.

17. A method of treating a mood disorder selected from the group consisting of depression of major depressive disorder, dementia with depressive symptoms, major depressive disorder, endogenous depression, melancholia, depression incombination with psychotic episodes, bipolar disorder with depressive phase, refractory depression, dementia of the Alzheimer's type with depressive symptoms, Parkinson's disease with depressive symptoms, senile dementia, mood disorders associated with cerebral blood vessels and mood disorders following head injury in a patient comprising: administering to the patient an effective amount of a pharmaceutical composition which comprise(s) (a) a compound selected from aripiprazole or metabolite of aripiprazole wherein the metabolite of aripiprazole is selected from the group consisting of dehydroaripiprazole, DM-1451 and in combination with (b) at least one serotonin reuptake inhibitor selected from the group consisting of fluoxetine, duloxetine, venlafaxine, milnacipran, citalopram, fluvoxamine, paroxetine, sertraline, escitalopram, and salts thereof.

18. A method of treating a mood disorder selected from the group consisting of depression of major depressive disorder, dementia with depressive symptoms, major depressive disorder, endogenous depression, melancholia, depression in combination with psychotic episodes, bipolar disorder with depressive phase, refractory depression, dementia of the Alzheimer's type with depressive symptoms, Parkinson's disease with depressive symptoms, senile dementia, mood disorders associated with cerebral blood vessels and mood disorders following head injury in a patient comprising: administering to the patient an effective amount of a pharmaceutical composition comprising aripiprazole in combination with at least one serotonin reuptake inhibitor selected from the group consisting of fluoxetine, duloxetine, venlafaxine, milnacipran, citalopram, fluvoxamine, paroxetine, sertraline and salts thereof.

19. A method of treating mood disorder selected from the group consisting of depression of major depressive disorder, dementia with depressive symptoms, major depressive disorder, endogenous depression, melancholia, depression in combination with psychotic episodes, bipolar disorder with depressive phase, refractory depression, dementia of the Alzheimer's type with depressive symptoms, Parkinson's disease with depressive symptoms, senile dementia, mood disorders associated with cerebral blood vessels and mood disorders following head injury in a patient comprising: administering to the patient of an effective amount of a pharmaceutical composition comprising aripiprazole in combination with at least one serotonin reuptake inhibitor selected from escitalopram and salt thereof.

20. The method of claim 18, wherein at least one serotonin reuptake inhibitor is citalopram.

21. The method of any one of claims 17 to 20, wherein aripiprazole is anhydrous aripiprazole crystals B.

22. The method of any one claims 17 to 20, wherein the pharmaceutical composition further comprises at least one pharmaceutically acceptable carrier.

23. The method of any one claims 17 to 20, wherein the mood disorder is useful for the treatment of depression of major depressive disorder.

24. The method of any one of claims 17 to 20, wherein the mood disorder is useful for the treatment of major depressive disorder or dementia with depressive symptoms.

25. The method of any one of claims 17 to 20, wherein the mood disorder is useful for the treatment of major depressive disorder, endogenous depression, melancholia, depression in combination with psychotic episodes, bipolar disorder with depressive phase, refractory depression, dementia of the Alzheimer's type with depressive symptoms, Parkinson's disease with depressive symptom, senile dementia, mood disorder associated with cerebral blood vessels or mood disorder following head injury.

26. A method of treating a mood disorder selected from the group consisting of depression of major depressive disorder, dementia with depressive symptoms, major depressive disorder, endogenous depression, melancholia, depression in combination with psychotic episodes, bipolar disorder with depressive phase, refractory depression, dementia of the Alzheimer's type with depressive symptoms, Parkinson's disease with depressive symptoms, senile dementia, mood disorders associated with cerebral blood vessels and mood disorders following head injury in a patient comprising: administering to the patient of an effective amount of pharmaceutical composition comprising at least one metabolite of aripiprazole selected from the group consisting of dehydroaripiprazole, DM-1451 and DM-1452 DM in combination with at least one serotonin reuptake inhibitor selected from the group consisting of fluoxetine, duloxetine, venlafaxine, milnacipran, citalopram, fluvoxamine, paroxetine, sertraline, escitalopram and salts thereof.

27. The method of claim 26, wherein the at least one serotonin reuptake inhibitor is citalopram.

28. The method of claim 26, wherein the at least one serotonin reuptake inhibitor is escitalopram.

29. The method of any one of claims 26 to 28, wherein the pharmaceutical composition further comprises at least one pharmaceutically acceptable carrier.

30. The method of any one of claims 26 to 28, wherein the mood disorder is useful for the treatment of depression of major depressive disorder.

31. The method of any one of claims 26 to 28, wherein the mood disorder is useful for the treatment of major depressive disorder or dementia with depressive symptoms.

32. The method of any one of claims 26 to 28, wherein the mood disorder is useful for the treatment of major depressive disorder, endogenous depression, melancholia, depression in combination with psychotic episodes, bipolar disorder with depressive phase, refractory depression, dementia of the Alzheimer's type with depressive symptoms, Parkinson's disease with depressive symptom, senile dementia, mood disorder associated with cerebral blood vessels or mood disorder following head injury.
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