Pharmacologically-augmented Cognitive Therapies (PACTs) for Schizophrenia.

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02634684

Run by

University of California, San Diego

People needed

82

Starts

2014-07-01

Expected to finish

2020-08-01

Last updated by the study team

2021-08-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18-55 years old:
• Drug Free (No recreational/street drugs)
• Diagnosis of Schizophrenia or Schizoaffective Disorder, Depressed Type
• Must be stable on antipsychotic medication for at least 1 month
• Any medications other than antipsychotic medications need to be stable for at least 1 week

You may not qualify if…

• Dominant hand injury
• Hearing impairment at 40 dB
• Irregular menstrual cycle or cycle is no within in 25-35 days (menopausal is eligible)
• EKG, conduction abnormalities confirmed by cardiologist
• Reading component of Wide Range Achievement Test 4 (WRAT4) Score less than 70
• Any serious illness, including: Insulin-dependent diabetes, HIV, AIDS, cancer, stroke, heart attack, uncontrolled hypothyroidism
• Sleep apnea
• A diagnosis of epilepsy or history of seizures with loss of consciousness
• Open/closed head injury with loss of consciousness greater than 1 minute at any time in the lifetime
• Blood pressure: Systolic Blood Pressure < 90 or > 160, Diastolic Blood Pressure < 45 or > 95
• Heart Rate < 55 or > 110
• Current use of Dexatrim or drugs containing phenylephrine (eligible if not used for at least 72 hours prior to participation)
• Current use of St. John's Wort, Milk Thistle (eligible if for at least 1 month)
• Self report of any illicit drug use within the last 30 days
• Positive urine toxicology
• Self-report of any use of ecstasy, lysergic acid diethylamide (LSD), mushrooms, gamma hydroxybutyrate (GHB), ketamine, phencyclidine (PCP), heroin or any intravenous-drugs within past year
• If there is a history of substance abuse/addiction, participant must be in remission for at least 6 months
• Within 1 month of recent psychiatric hospitalization
• Current mania
• Dementia/Alzheimer's diagnosis
• Mania episode meeting criteria outlined in the MINI-International Neuropsychiatric Interview Plus 6.0 (M.I.N.I. plus 6.0) anytime in the lifetime (hypomania/Bipolar II eligible)

Where it is running

• Clinical Teaching Facility (CTF-B102) at UCSD Medical Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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