CompletedPhase 2

Pharmacologically-augmented Cognitive Therapies (PACTs) for Schizophrenia.

United States82 participantsStarted 2014-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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, phencyclid…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prepulse Inhibition (PPI)

Timeframe: two visits, 1 week apart, each visit lasting approximately 6 hours

Trial details

NCT IDNCT02634684

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08

Results submitted2021-06-08

View on ClinicalTrials.gov More Schizophrenia trials