Trial Outcomes & Findings for Clinical Trial of Dipyridamole in Schizophrenia (NCT NCT00349973)
NCT ID: NCT00349973
Last Updated: 2019-11-04
Results Overview
The Brief Psychiatric Rating Scale (BPRS) consists of 20 items, with 6 of these items used to assess positive symptom change. The BPRS positive symptom items are: somatic concern, conceptual disorganization, hostility, suspiciousness, hallucinatory behavior, and unusual thought content. Each scale ranges from "1=Not Present" to "7=Very Severe". A higher score indicates a more severe positive symptom rating.
COMPLETED
NA
29 participants
Baseline and follow-up
2019-11-04
Participant Flow
Four participants were excluded prior to randomization (1:positive urine tox screen; 1:participant uncooperative with clinical interview; 1:withdrew consent; 1:history of cardiovascular disease).
Participant milestones
| Measure |
Dipyridamole
Dipyridamole
Dipyridamole : Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm
|
Olanzapine
Olanzapine
Olanzapine : Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Dipyridamole
Dipyridamole
Dipyridamole : Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm
|
Olanzapine
Olanzapine
Olanzapine : Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Clinical Trial of Dipyridamole in Schizophrenia
Baseline characteristics by cohort
| Measure |
Dipyridamole
n=12 Participants
Dipyridamole
Dipyridamole : Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm
|
Olanzapine
n=8 Participants
Olanzapine
Olanzapine : Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and follow-upPopulation: Participants completing the BPRS assessment.
The Brief Psychiatric Rating Scale (BPRS) consists of 20 items, with 6 of these items used to assess positive symptom change. The BPRS positive symptom items are: somatic concern, conceptual disorganization, hostility, suspiciousness, hallucinatory behavior, and unusual thought content. Each scale ranges from "1=Not Present" to "7=Very Severe". A higher score indicates a more severe positive symptom rating.
Outcome measures
| Measure |
Dipyridamole
n=9 Participants
Dipyridamole
Dipyridamole : Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm
|
Olanzapine
n=5 Participants
Olanzapine
Olanzapine : Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm
|
|---|---|---|
|
Change in Positive Symptoms by Treatment Assignment
Baseline - Hallucination
|
2.67 units on a scale
Standard Deviation 2.12
|
3.80 units on a scale
Standard Deviation 1.30
|
|
Change in Positive Symptoms by Treatment Assignment
Follow-Up - Hallucination
|
2.600 units on a scale
Standard Deviation 2.191
|
2.500 units on a scale
Standard Deviation 0.707
|
|
Change in Positive Symptoms by Treatment Assignment
Baseline - Unusual Thought Content
|
3.111 units on a scale
Standard Deviation 1.167
|
3.400 units on a scale
Standard Deviation 0.894
|
|
Change in Positive Symptoms by Treatment Assignment
Baseline - Somatic Concern
|
2.222 units on a scale
Standard Deviation 1.716
|
1.400 units on a scale
Standard Deviation 0.548
|
|
Change in Positive Symptoms by Treatment Assignment
Follow-Up - Somatic Concern
|
1.60 units on a scale
Standard Deviation 1.34
|
1.00 units on a scale
Standard Deviation 0.00
|
|
Change in Positive Symptoms by Treatment Assignment
Baseline - Conceptual Disorganization
|
2.667 units on a scale
Standard Deviation 1.225
|
2.600 units on a scale
Standard Deviation 0.894
|
|
Change in Positive Symptoms by Treatment Assignment
Follow-Up - Conceptual Disorganization
|
2.00 units on a scale
Standard Deviation 1.41
|
2.00 units on a scale
Standard Deviation 1.41
|
|
Change in Positive Symptoms by Treatment Assignment
Baseline - Hostility
|
1.222 units on a scale
Standard Deviation 0.667
|
1.200 units on a scale
Standard Deviation 0.447
|
|
Change in Positive Symptoms by Treatment Assignment
Follow-Up - Hostility
|
1.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 1.41
|
|
Change in Positive Symptoms by Treatment Assignment
Baseline - Suspiciousness
|
4.11 units on a scale
Standard Deviation 1.54
|
3.40 units on a scale
Standard Deviation 1.82
|
|
Change in Positive Symptoms by Treatment Assignment
Follow-Up - Suspiciousness
|
3.000 units on a scale
Standard Deviation 1.581
|
1.500 units on a scale
Standard Deviation 0.707
|
|
Change in Positive Symptoms by Treatment Assignment
Follow-Up - Unusual Thought Content
|
2.800 units on a scale
Standard Deviation 2.168
|
1.500 units on a scale
Standard Deviation 0.707
|
PRIMARY outcome
Timeframe: Baseline and Follow-UpPopulation: Participants completing SANS assessment.
The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. Mean SANS total score by treatment and week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.
Outcome measures
| Measure |
Dipyridamole
n=9 Participants
Dipyridamole
Dipyridamole : Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm
|
Olanzapine
n=5 Participants
Olanzapine
Olanzapine : Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm
|
|---|---|---|
|
Change in Negative Symptoms by Treatment Assignment
Baseline (Phase 1/Week 1)
|
23.3 units on a scale
Standard Deviation 14.7
|
25.6 units on a scale
Standard Deviation 20.5
|
|
Change in Negative Symptoms by Treatment Assignment
Follow-Up (Phase 4/Week 1)
|
25.8 units on a scale
Standard Deviation 10.7
|
27.0 units on a scale
Standard Deviation 29.7
|
PRIMARY outcome
Timeframe: Baseline and Follow-UpPopulation: Participants completing cognitive testing.
The RBANS is a brief, individually administered test designed to evaluate neuropsychological status of adults, ages 20-89. The 12 subtests measure attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The raw scores from the subtests are scaled together to create index scores, and these are summed for conversion to a total scale score. Higher score equals a better outcome. The total index score range for the RBANS is 40-160.
Outcome measures
| Measure |
Dipyridamole
n=5 Participants
Dipyridamole
Dipyridamole : Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm
|
Olanzapine
n=2 Participants
Olanzapine
Olanzapine : Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm
|
|---|---|---|
|
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Baseline (Phase 1/Week 1)
|
73.00 units on a scale
Standard Deviation 15.41
|
59.00 units on a scale
Standard Deviation 1.41
|
|
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Follow-Up (Phase 3/Week 6)
|
77.40 units on a scale
Standard Deviation 14.83
|
65.00 units on a scale
Standard Deviation 2.83
|
Adverse Events
Dipyridamole
Olanzapine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elliot Hong, Prinicipal Investigator
University of Maryland, Baltimore
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place