Trial Outcomes & Findings for Risperidone and Desipramine in Alcohol Use and Schizophrenia (NCT NCT01411085)
NCT ID: NCT01411085
Last Updated: 2018-03-23
Results Overview
Alcohol/other substance use (including tobacco) will be assessed primarily by weekly self-report using the Timeline Followback (TLFB) method enhanced by procedures to strengthen the reliability and validity of this measure. It involves asking participants to retrospectively estimate their alcohol and other substance use.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Weekly for 14 weeks, using data from last 8 weeks
Results posted on
2018-03-23
Participant Flow
Two participants were enrolled in a risperidone + placebo arm, but in 6/2013 the design of the study was changed to include only the risperidone + desipramine arm.
Participant milestones
| Measure |
Risperidone + Desipramine
All participants were treated with risperidone (or risperidone-like agent, including risperidone long-acting, paliperidone and paliperidone palmitate) at the time that treatment with desipramine was initiated. The target of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
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|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Risperidone + Desipramine
All participants were treated with risperidone (or risperidone-like agent, including risperidone long-acting, paliperidone and paliperidone palmitate) at the time that treatment with desipramine was initiated. The target of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
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|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
10 study subjects were enrolled.
Baseline characteristics by cohort
| Measure |
Risperidone + Desipramine
n=10 Participants
All participants were treated with risperidone (or risperidone-like agent, including risperidone long-acting, paliperidone or paliperidone palmitate) at the time treatment with desipramine was initiated. The target dose of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants • 10 study subjects were enrolled.
|
|
Age, Categorical
Between 18 and 65 years
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10 Participants
n=93 Participants • 10 study subjects were enrolled.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants • 10 study subjects were enrolled.
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 9.82 • n=93 Participants • 10 study subjects were enrolled.
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants • 10 study subjects were enrolled.
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants • 10 study subjects were enrolled.
|
|
Region of Enrollment
United States
|
10 Participants
n=93 Participants • 10 study subjects were enrolled.
|
PRIMARY outcome
Timeframe: Weekly for 14 weeks, using data from last 8 weeksPopulation: The analysis was performed on all completers (N=7).
Alcohol/other substance use (including tobacco) will be assessed primarily by weekly self-report using the Timeline Followback (TLFB) method enhanced by procedures to strengthen the reliability and validity of this measure. It involves asking participants to retrospectively estimate their alcohol and other substance use.
Outcome measures
| Measure |
Risperidone + Desipramine
n=7 Participants
All participants were treated with risperidone (or a risperidone-like agent, including risperidone long-acting, paliperidone or paliperidone palmitate). The target dose of oral risperidone was 4 mg/day, though variations were allowed. The target dose of desipramine was 100 mg/day.
|
|---|---|
|
Timeline Followback Assessing Number of Drinks Per Week
|
35.9 Drinks per week
Standard Deviation 20.4
|
Adverse Events
Risperidone + Desipramine
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Risperidone + Desipramine
n=10 participants at risk
All participants were treated with risperidone (or a risperidone-like agent including: risperidone long-acting, paliperdione, and paliperidone palmitate) at the time treatment with desipramine is initiated. The target dose of oral risperidone is 4mg/day though variations were allowed. The target dose of desipramine was 100mg/day.
Risperidone + Desipramine
|
|---|---|
|
Psychiatric disorders
Suicidal ideation
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Suicide atttempt
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Alcohol intoxication
|
10.0%
1/10 • Number of events 2
|
Other adverse events
| Measure |
Risperidone + Desipramine
n=10 participants at risk
All participants were treated with risperidone (or a risperidone-like agent including: risperidone long-acting, paliperdione, and paliperidone palmitate) at the time treatment with desipramine is initiated. The target dose of oral risperidone is 4mg/day though variations were allowed. The target dose of desipramine was 100mg/day.
Risperidone + Desipramine
|
|---|---|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 2
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Diarrehea
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Dizziness
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Dry Mouth
|
20.0%
2/10 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
2/10 • Number of events 2
|
|
Infections and infestations
Gum Infection
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Increased appetite
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Irritability
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Libido decrease
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Involuntary movements
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Abnormal ECG
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Orthostatic Hypotension
|
40.0%
4/10 • Number of events 6
|
|
Cardiac disorders
Right bundle branch
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Alcohol intoxication
|
10.0%
1/10 • Number of events 7
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain
|
20.0%
2/10 • Number of events 3
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Infection
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
GERD
|
10.0%
1/10 • Number of events 1
|
Additional Information
Alan I Green, MD
Geisel School of Medicine at Dartmouth
Phone: 603-650-7549
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place