PREPARATION AND USE OF (+)-1-(3,4-DICHLOROPHENYL)-3-AZABICYCLO[3.1.0]HEXANE IN THE TREATMENT OF CONDITIONS AFFECTED BY MONOAMINE NEUROTRANSMITTERS
The present invention relates to (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane and pharmaceutically acceptable active salts, polymorphs, glycosylated derivatives, metabolites, solvates, hydrates, and/or prodrugs of (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane and their use alone or in combination with additional psychotherapeutic compositions in the treatment of conditions affected by monoamine neurotransmitters, including treatment of refractory individuals.
1 - 92 . (canceled)
93 . A method for treating depression in a human in need thereof, wherein the method comprises administering to the human an effective amount of (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or a pharmaceutically acceptable salt thereof, wherein the human has previously been refractory to a prior course of treatment for depression due to an intolerable side effect from the prior course of treatment and wherein the side effect is sexual dysfunction.
94 . The method of claim 93 , wherein the method comprises administering (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane hydrochloride.
95 . The method of claim 94 , wherein the method comprises administering Polymorph A of (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane hydrochloride.
96 . The method of claim 93 , wherein the human was refractory to treatment with an antidepressant, wherein the antidepressant is a tri-cyclic antidepressant, specific monoamine reuptake inhibitor, selective serotonin reuptake inhibitor, selective norepinephrine or noradrenaline reuptake inhibitor, selective dopamine reuptake inhibitor, norepinephrine-dopamine reuptake inhibitor, monoamine oxidase inhibitor, atypical antidepressant, atypical antipsychotic, anticonvulsant, or opiate agonist.
97 . The method of claim 96 , wherein the antidepressant is a selective serotonin reuptake inhibitor.
98 . The method of claim 93 , wherein the human failed to respond to the prior course of treatment.
99 . The method of claim 93 , wherein the human did not achieve remission with the prior course of treatment.
100 . The method of claim 93 , wherein the method comprises administering the (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof in an amount of 50 mg to 75 mg once or twice daily.
101 . The method of claim 93 , wherein the method comprises administering the (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or pharmaceutically acceptable salt thereof in an amount of 100 mg to 200 mg once or twice daily.
102 . A method of treating depression in a human in need thereof, wherein the method comprises administering to the human a pharmaceutical composition comprising an effective amount of (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane or a pharmaceutically acceptable salt thereof, wherein administration of the pharmaceutical composition causes fewer side effects than administration of a pharmaceutical composition comprising a balanced triple reuptake inhibitor.