Cognitive REmediation After Trauma Exposure Trial = CREATE Trial

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy of methylphenidate and galantamine in the treatment of persistent cognitive symptoms associated with posttraumatic stress disorder (PTSD) and/or traumatic brain injury (TBI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• Collaborators: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Galantamine; Methylphenidate

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