Methods of treating bipolar disorder
The disclosure provides the use of particular substituted heterocycle fused gamma-carboline compounds as pharmaceuticals for the treatment of residual symptoms of psychosis or schizophrenia. The disclosure also provides novel long acting injectable formulations of particular substituted heterocycle fused gamma-carboline compounds and use of such long acting injectable formulations for the treatment of residual symptoms of psychosis or schizophrenia.
1. A method for the treatment of bipolar disorder I and/or bipolar II disorder comprising administering to a patient in need thereof an effective amount of a Compound of Formula I:
wherein:
X is —N(CH 3 )— and Y is —C(O)—;
in free or pharmaceutically acceptable salt form, wherein said Compound is not used in combination with another antipsychotic agent.
2. The method according to claim 1 , wherein the compound of Formula I is in pharmaceutically acceptable salt form.
3. The method according to claim 1 , wherein the compound of Formula I is in toluenesulfonic acid addition salt form.
4. The method according to claim 1 , wherein the bipolar disorder is bipolar I disorder.
5. The method according to claim 1 , wherein the bipolar disorder is bipolar II disorder.
6. The method according to claim 1 , wherein the effective amount of the Compound of Formula I is 20 mg to 60 mg per day, measured as the weight of the corresponding free base form of the Compound.
7. The method according to claim 1 , wherein the effective amount of the Compound of Formula I is 40 mg to 60 mg per day, measured as the weight of the corresponding free base form of the Compound.
8. The method according to claim 1 , wherein the effective amount of the Compound of Formula I is about 40 mg per day, measured as the weight of the corresponding free base form of the Compound.
9. The method according to claim 1 , wherein the compound is in toluenesulfonic acid addition salt form and the effective amount of the Compound of Formula I is 60 mg of the salt form administered once per day (equivalent to about 41.7 mg of the free base).
10. The method according to claim 1 , wherein the patient has bipolar disorder with psychotic symptoms.
11. The method according to claim 1 , wherein the patient has bipolar depression.
12. The method according to claim 1 , wherein the method is effective in treating the symptoms of depression of bipolar disorder.
13. The method according to claim 4 , wherein the method is effective in treating the symptoms of depression of bipolar disorder.
14. The method according to claim 5 , wherein the method is effective in treating the symptoms of depression of bipolar disorder.
15. The method according to claim 9 , wherein the bipolar disorder is bipolar I disorder.
16. The method according to claim 15 , wherein the method is effective in treating the symptoms of depression of bipolar disorder.
17. The method according to claim 9 , wherein the bipolar disorder is bipolar II disorder.
18. The method according to claim 17 , wherein the method is effective in treating the symptoms of depression of bipolar disorder.
19. The method according to claim 1 , wherein the Compound is administered as the sole therapeutic agent for the treatment of said bipolar disorder.
20. The method according to claim 1 , wherein the method does not result in hyperprolactinemia, EPS/akathisia, weight gain or cardiovascular side effects.
21. The method according to claim 9 , wherein the Compound is administered as the sole therapeutic agent for the treatment of said bipolar disorder.
22. The method according to claim 9 , wherein the method does not result in hyperprolactinemia, EPS/akathisia, weight gain or cardiovascular side effects.
23. The method according to claim 1 , wherein the method does not result in EPS/akathisia or weight gain.
24. The method according to claim 9 , wherein the method does not result in EPS/akathisia or weight gain.