At a glance
ClinicalIndex Comparison Record- ✓Age 18-55 years
- ✓Diagnosis of schizophrenia or schizoaffective disorder, depressed type
- ✓Stable on antipsychotic medication for at least 1 month
- ✓Drug-free (no recreational or street drugs)
- ✕Self-reported illicit drug use within last 30 days or positive urine toxicology
- ✕Any use of ecstasy, LSD, mushrooms, GHB, ketamine, PCP, heroin, or intravenous drugs within past year
- ✕History of substance abuse/addiction unless in remission ≥6 months
- ✕Current mania or lifetime mania episode (hypomania/Bipolar II eligible)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacologic Augmentation of Neurocognition and Cognitive Training in Psychosis
In Brief
A Phase 2 clinical trial evaluating Dextroamphetamine and Placebo for Schizophrenia. Completed, enrolled 82 participants across 1 site.
Detailed Summary
This application seeks renewed support for MH59803, "Dopaminergic substrates of startle gating across species," to extend a clear path of "bench-to-bedside" progress towards a critical paradigm shift in therapeutic models for schizophrenia (SZ) and schizoaffective disorder, depressed type (SZA): the use of Pharmacologic Augmentation of Cognitive Therapies (PACTs). This novel therapeutic strategy for SZ/SZA directly addresses the need for more effective treatments for this devastating disorder. MH59803 has investigated the neural regulation of laboratory-based measures of deficient information processing in SZ/SZA patients, using rodents and healthy human subjects (HS) to explicate the biology of these deficits, and to establish a rational basis for developing novel therapies for SZ/SZA. In its first 9 years, MH59803 studies of the neural regulation of prepulse inhibition (PPI) of startle in rats focused on basic neurobiological and molecular mechanisms. Over the past 2 years of support, MH59803 studies moved "from bench-to-bedside," focusing on dopamine (DA) agonist effects on PPI and neurocognition in HS, and their regulation by genes identified in cross-species studies. These studies detected biological markers that predict PPI-enhancing and pro-cognitive effects of the DA releaser, amphetamine (AMPH) in humans, leading to specific predictions of AMPH effects on PPI, neurocognition and Targeted Cognitive Training in SZ/SZA patients. If confirmed in the present application, these predictions could help transform therapeutic approaches to SZ/SZA. This renewal application of MH59803 thus reflects a logical progression of studies at systems and molecular levels, translated first to HS, and now to potentially transformative therapeutic models in SZ/SZA patients.
Study Details
Timeline
Interventions
Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.