Arbuthnott K, Frank J Trail making test, part B as a measure of executive control: validation using a set-switching paradigm. J Clin Exp Neuropsychol. 2000 Aug;22(4):518-28. doi: 10.1076/1380-3395(200008)22:4;1-0;FT518.
Burdick KE, Ketter TA, Goldberg JF, Calabrese JR Assessing cognitive function in bipolar disorder: challenges and recommendations for clinical trial design. J Clin Psychiatry. 2015 Mar;76(3):e342-50. doi: 10.4088/JCP.14cs09399.
Carver CS, Ganellen RJ Depression and components of self-punitiveness: high standards, self-criticism, and overgeneralization. J Abnorm Psychol. 1983 Aug;92(3):330-7. doi: 10.1037//0021-843x.92.3.330. No abstract available.
Carver CS, Johnson SL Tendencies Toward Mania and Tendencies Toward Depression Have Distinct Motivational, Affective, and Cognitive Correlates. Cognit Ther Res. 2009 Dec;33(6):552-569. doi: 10.1007/s10608-008-9213-y.
Carver CS, Scheier MF, Weintraub JK Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.
Carver, C S., White, T.L., 1994. Behavioral inhibition, behavioral activation, and affective responses to impending reward and punishment: the BIS/BAS scales. J. Pers. Soc. Psychol. 67, 319-333.
Bipolar Remediation of Affective Impulsivity and Negative Symptomatology (BRAINS)
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
