Methods for treating suicidal ideation
Inventors
Charney, Dennis S. • Mathew, Sanjay J. • Manji, Husseini K. • Zarate, Carlos A. • Krystal, John H.
Assignees
Yale University • Icahn School of Medicine at Mount Sinai • US Department of Veterans Affairs • US Department of Health and Human Services
Publication Number
US-9539220-B2
Publication Date
2017-01-10
Expiration Date
2027-03-20
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Abstract
Methods and compositions for the treatment of treatment-resistant depression are described. More specifically, the invention demonstrates that intranasal administration of ketamine is effective to ameliorate the symptoms of depression in a patient who has not responded to an adequate trial of one antidepressant in the current episode and has recurrent or chronic depressive symptoms (>2 years).
Core Innovation
The invention provides methods and compositions for treating treatment-resistant depression using ketamine administered intranasally, intravenously, or transdermally. It demonstrates that intranasal administration of ketamine is effective to alleviate symptoms of depression in patients who have not responded to adequate trials of antidepressants and who have recurrent or chronic depressive symptoms for more than two years. The ketamine is administered at doses between about 0.1 mg/kg per day to about 3.0 mg/kg per day, with symptom alleviation occurring within about 2 hours of administration and effects lasting up to 7 days or longer.
The problem addressed is the limitations of existing antidepressant treatments, which have a delayed onset of several weeks, resulting in continued patient suffering and a high risk of suicidal behavior during this lag period. Treatment-resistant depression remains a serious clinical challenge with many patients not responding to traditional antidepressants. Existing therapies also require hospital visits for intravenous administration and are associated with side effects and poor tolerability. There is a need for rapid-acting, effective, and patient-friendly antidepressant treatments that can be administered on an outpatient basis to improve patient compliance and outcomes.
Claims Coverage
This patent includes two independent claims directed to methods of treating recurrent thoughts of death, suicidal ideation, or suicidal attempts using intranasal administration of ketamine compositions.
Method of intranasal administration of ketamine composition for treating suicidal symptoms
A method consisting of intranasally administering to a patient a composition consisting of ketamine at a dosage sufficient to alleviate recurrent thoughts of death, suicidal ideation, or suicidal attempts, along with at least one pharmaceutically acceptable excipient.
Method of intranasal administration of a ketamine composition with multiple components
A method of intranasally administering to a patient a composition containing a first component consisting of ketamine at a dosage sufficient to alleviate suicidal symptoms and a second component comprising at least one pharmaceutically acceptable excipient.
The claims focus on intranasal administration of ketamine, either as a single component or a multi-component composition, at dosages sufficient to rapidly alleviate suicidal ideation and related symptoms. The claimed methods include single or multiple dose regimens with effective doses between about 0.1 mg/kg per day to about 3.0 mg/kg per day, providing rapid and sustained antidepressant effects.
Stated Advantages
Rapid onset of antidepressant effects within about 2 hours of administration.
Sustained alleviation of depressive symptoms and suicidal ideation for up to 7 days or longer after a single dose.
Non-invasive, patient self-administration possible via intranasal formulations, improving patient acceptance and compliance.
Potential to reduce doses of additional antidepressant agents when used in combination with ketamine.
Intranasal administration eliminates the need for hospital visits or intravenous injections, enabling outpatient treatment.
Ketamine is an inexpensive, readily available drug with minor adverse side effects at therapeutic doses.
Documented Applications
Treatment of treatment-resistant major depression, including unipolar and bipolar depression, seasonal affective disorder, mood disorders related to medical conditions, and chronic depressive symptoms lasting longer than two years.
Rapid treatment of recurrent thoughts of death, suicidal ideation, and suicidal attempts.
Outpatient depression management including self-administration of ketamine via nasal inhalers or sprays.
Use of ketamine in combination with other antidepressant agents such as lithium, pharmaceutical antidepressants, herbal antidepressants, anticonvulsants, mood stabilizers, antipsychotics, and benzodiazepines.
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