Treatment of psychiatric disorder

A method of treating a person suffering from a psychiatric disorder, the method comprising orally administering to the person a unit dose comprising nefazodone hydrochloride, risperidone, and one or more pharmaceutical excipients, the administration comprises a dosing regimen comprising:

• an initial dosing comprising administering a first unit dose comprising nefazodone hydrochloride and risperidone,
• a dosing escalation comprising administering a second unit dose comprising nefazodone hydrochloride and risperidone, and
• a maintenance dosing comprising administering a third unit dose comprising nefazodone hydrochloride and risperidone;
• wherein,
• the initial dosing comprises administering a daily dose of 50 mg nefazodone hydrochloride and 0.375±0.125 mg risperidone;
• the initial dosing is carried out for 2 weeks;
• the dosing escalation comprises increasing the nefazodone hydrochloride in increments of 100 mg per day, until the maintenance dose is achieved;
• the dosing escalation comprises increasing the risperidone in increments of 0.5 mg per day, until the maintenance dose is achieved;
• the dosing escalation occurs at intervals of once per at least 1 week;
• the dosing escalation occurs over a period of time of 3-5 weeks;
• the maintenance dosing comprises administering a daily dose of 400 mg nefazodone hydrochloride and 1.5 mg risperidone;
• each dosing is carried out twice daily (BID) in a solid unit dose;
• and
• the person is monitored at least once per week by a medical professional for observation of emerging suicidal thoughts or behaviors.

A method of treating a person suffering from a psychiatric disorder, the method comprising orally administering to the person a unit dose comprising nefazodone hydrochloride, risperidone, and one or more pharmaceutical excipients, the administration comprises a dosing regimen comprising:

• a) an initial daily dose of (i) 0.25 mg risperidone and 50 mg nefazodone hydrochloride, or (ii) 0.50 mg risperidone and 50 mg nefazodone hydrochloride, administered in divided doses twice daily, in a solid oral dosage form, for a period of time of up to 2 weeks;
• i. wherein the daily dose of 0.25 mg risperidone and 50 mg nefazodone hydrochloride is administered BID as a solid oral dosage form comprising 0.125 mg risperidone and 25 mg nefazodone hydrochloride;
• ii. wherein the daily dose of 0.50 mg risperidone and 50 mg nefazodone hydrochloride is administered BID as a solid oral dosage form comprising 0.25 mg risperidone and 25 mg nefazodone hydrochloride;
• b) titrated daily doses of (i) 0.75 mg risperidone and 150 mg nefazodone hydrochloride, 1.25 mg risperidone and 250 mg nefazodone hydrochloride, 1.5 mg risperidone and 350 mg nefazodone hydrochloride, and 1.5 mg risperidone and 400 mg nefazodone hydrochloride, or (ii) 1.0 mg risperidone and 150 mg nefazodone hydrochloride, 1.5 mg risperidone and 250 mg nefazodone hydrochloride, 1.5 mg risperidone and 350 mg nefazodone hydrochloride, and 1.5 mg risperidone and 400 mg nefazodone hydrochloride, administered in divided doses twice daily, in a solid oral dosage form, for a period of time of 2-5 weeks;
• i. wherein the daily dose of 0.75 mg risperidone and 150 mg nefazodone hydrochloride is administered BID as a solid oral dosage form comprising 0.375 mg risperidone and 75 mg nefazodone hydrochloride;
• ii. wherein the daily dose of 1.25 mg risperidone and 250 mg nefazodone hydrochloride is administered BID as a solid oral dosage form comprising 0.625 mg risperidone and 125 mg nefazodone hydrochloride;
• iii. wherein the daily dose of 1.5 mg risperidone and 350 mg nefazodone hydrochloride is administered BID as a solid oral dosage form comprising 0.75 mg risperidone and 175 mg nefazodone hydrochloride;
• iv. wherein the daily dose of 1.5 mg risperidone and 400 mg nefazodone hydrochloride is administered BID as a solid oral dosage form comprising 0.75 mg risperidone and 200 mg nefazodone hydrochloride;
• v. wherein the daily dose of 1.0 mg risperidone and 150 mg nefazodone hydrochloride is administered BID as a solid oral dosage form comprising 0.5 mg risperidone and 75 mg nefazodone hydrochloride;
• vi. wherein the daily dose of 1.5 mg risperidone and 250 mg nefazodone hydrochloride is administered BID as a solid oral dosage form comprising 0.75 mg risperidone and 125 mg nefazodone hydrochloride;
• vii. wherein the daily dose of 1.5 mg risperidone and 350 mg nefazodone hydrochloride is administered BID as a solid oral dosage form comprising 0.75 mg risperidone and 175 mg nefazodone hydrochloride;
• viii. wherein the daily dose of 1.5 mg risperidone and 400 mg nefazodone hydrochloride is administered BID as a solid oral dosage form comprising 0.75 mg risperidone and 200 mg nefazodone hydrochloride;
• c) maintenance daily dose of (i) 1.5-2 mg risperidone and 400-600 mg nefazodone hydrochloride;
• and
• d) monitoring the person at least once per week by a medical professional for observation of emerging suicidal thoughts or behaviors.

An oral unit dosage form comprising one or more pharmaceutically acceptable excipients and:

• (a) 0.1875±0.065 mg risperidone and 25±5 mg nefazodone hydrochloride;
• (b) 0.55±0.3 mg risperidone and 125±75 mg nefazodone hydrochloride;
• or
• (c) 0.875±0.125 mg risperidone and 250±mg nefazodone hydrochloride.

A therapeutic package comprising:

• (a) finished pharmaceutical container with printed indicial located thereon;
• and
• (b) multiple oral unit dosages contained within the finished pharmaceutical container;
• wherein,
• the oral unit dosages comprise:
• (i) multiple oral unit dosages, each independently comprising 0.1875±0.065 mg risperidone and 25±5 mg nefazodone hydrochloride;
• (ii) multiple oral unit dosages, each independently comprising 0.55±0.3 mg risperidone and 125±75 mg nefazodone hydrochloride;
• and/or
• (iii) multiple oral unit dosages, each independently comprising 0.875±0.125 mg risperidone and 250±mg nefazodone hydrochloride.