Trial Outcomes & Findings for 1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain (NCT NCT01844700)
NCT ID: NCT01844700
Last Updated: 2016-02-05
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
baseline to week 12
Results posted on
2016-02-05
Participant Flow
14 subjects were consented to the study and received screening, 7 subjects did not meet the eligibility criteria to the study and were therefore not randomized to the study
Participant milestones
| Measure |
Ziprasidone
(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 participants
|
Aripiprazole, Quetiapine, Risperidone
Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 participants
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Ziprasidone
(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 participants
|
Aripiprazole, Quetiapine, Risperidone
Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 participants
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
refused medication switch
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
stopped taking meds
|
0
|
1
|
Baseline Characteristics
1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain
Baseline characteristics by cohort
| Measure |
Ziprasidone
n=4 Participants
(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 patients were randomized to Ziprasidone
|
Aripiprazole, Quetiapine, Risperidone
n=3 Participants
Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 patients were randomized to usual care
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to week 12Outcome measures
| Measure |
Ziprasidone
n=4 Participants
(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes
|
Aripiprazole, Quetiapine, Risperidone
n=3 Participants
Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 participants, only two completed study, no sufficient data for weight changes
|
|---|---|---|
|
Weight Change
baseline
|
120.5 lbs
Standard Deviation 8.23
|
118.5 lbs
Standard Deviation 27.92
|
|
Weight Change
week 12 (n=1,2)
|
151 lbs
Standard Deviation 0
|
141 lbs
Standard Deviation 7.06
|
SECONDARY outcome
Timeframe: baseline to week 12Outcome measures
| Measure |
Ziprasidone
n=1 Participants
(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes
|
Aripiprazole, Quetiapine, Risperidone
n=2 Participants
Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 participants, only two completed study, no sufficient data for weight changes
|
|---|---|---|
|
Percent Weight Change Compared to Baseline Weight
|
11.58 percentage of weight change
Standard Deviation 0
|
5.66 percentage of weight change
Standard Deviation 4.66
|
SECONDARY outcome
Timeframe: baseline to week 12Outcome measures
| Measure |
Ziprasidone
n=4 Participants
(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes
|
Aripiprazole, Quetiapine, Risperidone
n=3 Participants
Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 participants, only two completed study, no sufficient data for weight changes
|
|---|---|---|
|
BMI Z-scores
baseline
|
-0.51 BMI z-score
Standard Deviation 0.55
|
-0.37 BMI z-score
Standard Deviation 1.05
|
|
BMI Z-scores
week 12 (n=1, n=2)
|
0.22 BMI z-score
Standard Deviation 0
|
0.38 BMI z-score
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: baseline to week 12Outcome measures
| Measure |
Ziprasidone
n=4 Participants
(20-160mg/d, bid) for 12 weeks
Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)
4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes
|
Aripiprazole, Quetiapine, Risperidone
n=3 Participants
Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
3 participants, only two completed study, no sufficient data for weight changes
|
|---|---|---|
|
BMI Percentile
baseline
|
32 BMI percentile
Standard Deviation 20.31
|
37.67 BMI percentile
Standard Deviation 36.66
|
|
BMI Percentile
week 12 (n=1, n=2)
|
59 BMI percentile
Standard Deviation 1
|
62.5 BMI percentile
Standard Deviation 30.41
|
Adverse Events
Ziprasidone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aripiprazole, Quetiapine, Risperidone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anil Malhotra, MD
Zucker Hillside Hospital, Division of Psychiatry Research
Phone: 718-470-8281
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place