Pharmacologically-augmented Cognitive Therapies (PACTs) for Schizophrenia.
NCT ID: NCT02634684
Last Updated: 2021-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2014-07-01
2020-08-31
Brief Summary
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Detailed Description
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Aim: To assess acute effects of AMPH (0 vs 10 mg po) on PPI, neurocognition and computerized TCT in AP-medicated SZ/SZA patients. Hypothesis: PPI- and MCCB-enhancing effects of AMPH seen previously in HS will also be detected in SZ/SZA patients, as will TCT-enhancing effects of AMPH. Prediction: In a within-subject, placebo-controlled, randomized design, AMPH (10 mg po) will increase PPI and enhance MCCB and TCT performance in medicated SZ/SZA patients, particularly among those characterized by low basal performance levels and/or the val/val rs4680 COMT polymorphism. Concurrent HS testing will confirm and extend findings of AMPH effects on PPI and neurocognition, and help interpret findings in SZ/SZA patients.
In all participants, the aim to assess acute effects of 0 vs. 10 mg po dextroamphetamine (AMPH) on Prepulse Inhibition (PPI), neurocognition MATRICS: Consensus Cognitive Battery; MCCB, and computerized Targeted Cognitive Training (TCT).
Hypothesis: AMPH will enhance:
1. PPI
2. neurocognition (MCCB performance)
3. computerized TCT performance in biomarker-identified SZ/SZA patients.
4. The PPI and MCCB-enhancing effects of AMPH seen previously in HS will also be detected in SZ/SZA patients, as will TCT-enhancing effects of AMPH.
Prediction: In a within-subject, placebo-controlled, randomized design, AMPH (10 mg po) will increase PPI and enhance MCCB and TCT performance in medicated SZ/SZA patients, particularly among those characterized by low basal performance levels and/or the val/val rs4680 COMT polymorphism. Concurrent HS testing will confirm and extend findings of AMPH effects on PPI and neurocognition, and help interpret findings in SZ/SZA patients.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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dextroamphetamine
Drug: Dexedrine, dextroamphetamine, d-amphetamine.
Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill 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.
Dextroamphetamine
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.
Placebo
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.
Placebo
Drug: Dexedrine, dextroamphetamine, d-amphetamine
Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill 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.
Dextroamphetamine
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.
Placebo
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.
Interventions
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Dextroamphetamine
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.
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
55 Years
ALL
Yes
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Neal R. Swerdlow, M.D., Ph.D.
Professor of Psychiatry and Director of the Research Residency Track at the University of California, San Diego, School of Medicine.
Principal Investigators
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Neal R. Swerdlow, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
UC San Diego
Locations
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Clinical Teaching Facility (CTF-B102) at UCSD Medical Center
San Diego, California, United States
Countries
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References
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Wilkinson GS, Robertson GJ (2006) WRAT4: Wide Range Achievement Test professional manual, 4th edn Psychological Assessment Resources: Lutz, FL
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Eyeblink Study
Identifier Type: OTHER
Identifier Source: secondary_id
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