N/A
Completed N=11
Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder
Source: ClinicalTrials.gov NCT01658150 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: MATRICS Consensus Cognitive Battery (MCCB) Change in Neurocognitive/Functional Measures — 39.8; 38.2 z-score
Summary
The purpose of this study is to evaluate the use of the drug isradipine for cognitive enhancement in patients diagnosed with schizophrenia and schizoaffective disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MATRICS Consensus Cognitive Battery (MCCB) Change in Neurocognitive/Functional Measures |
39.8; 38.2 | — |
| PRIMARY UPSA Communication Score |
15.3; 16.5 | — |
| PRIMARY Quality of Life (QoL) Scale |
96.5; 93.0 | — |
| SECONDARY Mean Change in PRISE Adverse Event Checklist Score |
-0.7 | — |
| SECONDARY Number of Participants With Normal ECG |
10; 10 | — |
| SECONDARY Number of Participants With Normal Chemistry Panel |
10; 10 | — |
| SECONDARY Number of Participants With Normal Complete Blood Count (CBC) |
10; 10 | — |
| SECONDARY Abnormal Involuntary Movement Scale (AIMS) |
0.7 | — |
| SECONDARY Modified Simpson Angus Scale (MSAS) |
-0.3 | — |
| SECONDARY Beck Scale for Suicidal Ideation (SSI) |
— | — |
| SECONDARY Number of Participants With Suicidal Acknowledgments |
— | — |
| SECONDARY Number of Participants With a Confirmed SCID-IV |
10 | — |
| SECONDARY Brief Psychiatric Rating Scale (BPRS) |
-1.0 | — |
| SECONDARY Scale for the Assessment of Negative Symptoms (SANS) |
-1.6 | — |
| SECONDARY Hamilton Rating Scale for Depression (HRSD) |
-0.6 | — |
| SECONDARY Clinical Global Impression Scale (CGI) |
-0.2 | — |
| SECONDARY Clinician Administered Rating Scale for Mania (CARS-M) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-60
- DSM-IV schizophrenia or schizoaffective disorder diagnosis
- Residual phase of illness criteria met at screen and baseline as defined by item scores of equal to or less than 4 on each of the Brief Psychiatric Rating Scale (BPRS) hallucinatory behavior, unusual thought content, conceptual disorganization items
- Hamilton Rating Scale for Depression (HRSD) equal to or less than 12
- Baseline Clinician Administered Scale for Mania (CARS-M) score of less than 5
- Simpson Angus Scale (SAS) total score equal to or less than 6
- Treatment with at least one but no more than two stably-dosed second-generation antipsychotic medication (other than clozapine) for equal to or greater than 2 months and no changes planned over the 4-week study period
Exclusion Criteria
- History of CNS trauma, neurological disorder, ADHD, mental retardation, learning disability, or other non-schizophrenic cause of cognitive impairment
- DSM-IV diagnosis of substance abuse/dependence within 3 months
- Pregnant women or women of childbearing age who are not using a medically accepted means of contraception
- Women who are breastfeeding
- Active, unstable medical problem that may interfere with cognition
- Current treatment for hypertension
- Uncontrolled hypertension
- Any drug known to interact with isradipine
- History of GI strictures
- History of heart disease
- Abnormal lab or ECG at screen
- Significant suicidal ideation at baseline (HRSD item 3>2)
- ECT treatment within 12 months
Data sourced from ClinicalTrials.gov (NCT01658150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.