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Table 2 Exclusion Criteria

From: The Collaborative Lithium Trials (CoLT): specific aims, methods, and implementation

Exclusion Criteria
1. Patient who is clinically stable on current medication regimen for bipolar disorder.
2. A current or lifetime diagnosis of Schizophrenia or Schizoaffective Disorder, a Pervasive Developmental Disorder, Anorexia Nervosa, Bulimia Nervosa, or Obsessive-Compulsive Disorder
3. Current DSM-IV diagnosis of Substance Dependence
4. Positive drug screen at screening and on retest 1–3 weeks later
5. Patients with symptoms of mania that may be attributable to a general medical condition, or secondary to use of medications (e.g., corticosteroids)
6. Evidence of any serious and/or unstable neurological illness for which treatment under the auspices of this study would be contra-indicated
7. Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol
8. Current general medical condition including neurological disease, diabetes mellitus, thyroid dysfunction, or renal dysfunction that might be affected adversely by lithium, could influence the efficacy or safety of lithium, or would complicate interpretation of study results
9. Evidence of current serious homicidal/suicidal ideation such that in the treating physician's opinion it would not be appropriately safe for the subject to participate in this study
10. Evidence of current active hallucinations and delusions such that in the treating physician's opinion it would not be appropriately safe for the subject to participate in this study
11. Concomitant prescription of over-the-counter medication or nutritional supplements that would interact with lithium or the subject's physical or mental status
12. Concurrent psychotherapy treatments provided outside the study initiated within 4 weeks prior to screening
13. Previous adequate trial with lithium (at least 4 weeks with lithium serum levels between 0.8–1.2 mEq/L)
14. History of allergy to lithium
15. Psychiatric hospitalization within 1 month of screening
16. Clinician's judgment that subject is not likely to be able to complete the study as an outpatient due to psychiatric reasons
17. History of lithium intolerance
18. Females who are currently pregnant or lactating
19. Sexually active females who, in the investigators' opinion, are not using an adequate form of birth control.
20. Subjects who are unable to swallow the study medication
21. Subjects for whom a baseline YMRS score of < 20 is anticipated
22. Subjects with an IQ less than 70 (determined using the Wechsler Abbreviated Scales of Intelligence {WASI}Vocabulary and Matrix Reasoning Subscales) [33]