Trial Duration Drug Dosage and Route of Administration

Protocol development requires specifying the duration of the trial a priori. The optimal duration varies across disorders. For example, for acute treatment of major depression, commonly 6-8 weeks of active treatment are employed; for mania, 3 weeks' duration is common. The shorter trial length for acute mania is used for convenience to allow sufficient time to assess a novel therapy without an unduly long duration of placebo treatment that would discourage enrollment.

Route of administration and specific dosage regimens are determined for each agent and vary according to the agent's physical properties (e.g., half-life, absorption) as well as the indication. (These are frequently determined in Phase II trials.) Drugs that can be prescribed once per day are obviously more convenient to administer than are agents that require multiple daily dosing, so manufacturers strive for once-daily dosing.

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