Clinical trial NCT01416948 (phase 2, status: terminated)
Conditions: posttraumatic stress disorder, traumatic brain injury
ICD codes: F43.10, F43.11, F43.12, Z87.820, Z13.850, S06.2X0S, S06.2X0A, S06.2X0D, S06.300S, S06.300A
Drugs: methylphenidate hydrochloride 20 mg, placebo capsule, galantamine 12 mg
SMILES: COC(=O)C(C1CCCCN1)C1=CC=CC=C1, CC1=CC(O)=CC(C)=C1Cl, [H][C@]12C[C@@H](O)C=C[C@]11CCN(C)CC3=C1C(O2)=C(OC)C=C3
Reason stopped: 
    the funding agency, dod, determined that the study could not meet its enrollment numbers by the
    end of the grant.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Aged 18-55 years

          2. Has a DSM-IV diagnosis of chronic (≥ 3 months duration) PTSD and/or a history of TBI
             (≥ 3 months duration) as established by the INTRuST standard TBI Screening
             questionnaire.

          3. TBI must have occurred ≥ 90 days prior to the screening visit

          4. With either diagnosis (i.e., PTSD or TBI), the subject must have clinically
             significant cognitive complaints, as indicated by a T score ≥ 60 on the postmorbid
             Cognitive scale of the RNBI

          5. Interested in receiving treatment for cognitive symptoms

          6. Capable of giving informed consent

        Exclusion Criteria:

          1. Known sensitivity, or previous adverse reaction(s), to GAL or other
             acetylcholinesterase inhibitors such as donepezil or rivastigmine OR Known sensitivity
             or previous adverse reactions to MPH or other stimulant medications (e.g.,
             dextroamphetamine, long-acting methylphenidate preparations)

          2. Pregnant, likely to become pregnant, or lactating (female subjects only)

          3. Does not speak English

          4. WRAT scaled score < 70

          5. History of glaucoma

          6. History of cardiac conditions (e.g., bradycardia, AV block) or history of taking
             medications that are associated with conduction abnormalities

          7. History of seizure disorder (including post-traumatic epilepsy), neurosurgery, or
             neurodisability [Note that history of "impact seizure" is permitted]

          8. Lifetime history of psychotic disorder, Bipolar I, stimulant abuse or dependence, or
             tic disorder

          9. Alcohol dependence, alcohol abuse*, substance abuse, or substance dependence in the
             past 6 months [*Alcohol abuse will be defined as MINI diagnosis of "Alcohol Abuse" AND
             an AUDIT-C score of ≥ 5; Dawson, Grant, & Stinson, 2005].

         10. Current active suicidal ideation, or history of actual attempt within the past 10
             years

         11. Current severe depressive symptoms, as indicated by a score of 20 or higher on the
             PHQ-9

         12. Current (or past 2-week) use of monoamine oxidase inhibitors [Washout period of at
             least 2 weeks is required]

         13. Current (or past 2-week) use of medications that potentiate cholinergic function
             (i.e., other cholinesterase inhibitors or procholinergic agents), or use of
             over-the-counter procholinergics [Washout period of at least 2 weeks is required]

         14. Current (or past 2-week) use of amphetamine-type stimulants or modafinil

         15. Current use of any other psychotropic medication that fails to meet the stabilization
             criterion of a minimum of 4 weeks on the same medication(s) and dose(s)

         16. Prior use of any other psychotropic medication that fails to meet the washout
             criterion of 2 weeks

         17. Concurrent cognitive therapy, that will not be discontinued at least 7 days prior to
             the baseline visit

         18. Baseline ECG and/or bloodwork reveals serious illness that precludes participation or
             use of study medications

         19. Any procedure requiring general anesthesia

         20. History of peptic ulcer disease or GI bleed or endoscopic procedure for GERD within
             the last year. Subjects taking physician prescribed treatment for GERD will be allowed
             to participate at the discretion of the PI after discussion with the primary treating
             physician.

         21. Current (or past 2-week) use of alpha 2 adrenergic agonists such as guanfacine