Trial Outcomes & Findings for Efficacy of Quetiapine in the Treatment of Patients With Schizophrenia and a Comorbid Substance Use Disorder (NCT NCT00156715)
NCT ID: NCT00156715
Last Updated: 2018-03-14
Results Overview
Timeline Follow-back (TLFB) procedure was used at screening and baseline to establish current substance use, and it was also used weekly during the course of the study to assess continued alcohol and other substance use. TLFB cosisted of using a calendar and sasking participants to report alcohol and other drug use since last visit. At the screening visit, the TLFB was done for the four weeks prior to the visit.
COMPLETED
PHASE4
23 participants
12 Weeks
2018-03-14
Participant Flow
Participants were recruited from two urban study sites, one in New England, the other in the Southeast, primarily through clinician referral, over two years. All participants gave informed consent.
Prior to starting quetiapine, all participants first completed a screening assessment to establish diagnosis, amount of alcohol (and other drugs) consumed, and current medications and medical status. This data was used to characterize the group and assess whether they met eligibility criteria for the study.
Participant milestones
| Measure |
QUET
After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Quetiapine in the Treatment of Patients With Schizophrenia and a Comorbid Substance Use Disorder
Baseline characteristics by cohort
| Measure |
QUET
n=23 Participants
After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Only those participants who received at least 4 weeks of treatment with quetiapine were included in this analysis. Site differences resulted in only the 11 participants from Site 1 to be included in the analysis. Participants from Site 2 were all admitted to the study directly from the hospital which could have affected their alcohol consumption.
Timeline Follow-back (TLFB) procedure was used at screening and baseline to establish current substance use, and it was also used weekly during the course of the study to assess continued alcohol and other substance use. TLFB cosisted of using a calendar and sasking participants to report alcohol and other drug use since last visit. At the screening visit, the TLFB was done for the four weeks prior to the visit.
Outcome measures
| Measure |
QUET
n=11 Participants
After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
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|---|---|
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Mean Number of Drinking Days Per Week
|
2.7 Drinking Days per Week
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Only those participants who received at least 4 weeks of treatment with quetiapine were included in this analysis. Site differences resulted in only the 11 participants from Site 1 to be included in this analysis. Participants from Site 2 were all admitted to the study directly from the hospital, which could have affected their behavior.
The main outcome measure of clinical symptoms was the Positive and Negative Symptoms Scale. This is a 30 item scale for assessing patients diagnosed with schizophrenia. Each item is rated on a 1 (absent) to 7 (extreme) scale. The minimum total score is 30 and the maximum is 210.
Outcome measures
| Measure |
QUET
n=11 Participants
After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
|
|---|---|
|
Clinical Symptoms
|
65.5 Units on a scale
Standard Deviation 16.5
|
Adverse Events
QUET
Serious adverse events
| Measure |
QUET
n=16 participants at risk
After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
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|---|---|
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Psychiatric disorders
Increased Psychosis
|
12.5%
2/16 • Number of events 3 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lump in Breast
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
|
Psychiatric disorders
Suicidal Ideation/Attempt
|
12.5%
2/16 • Number of events 2 • 12 weeks
|
Other adverse events
| Measure |
QUET
n=16 participants at risk
After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
|
|---|---|
|
General disorders
Dry Mouth
|
43.8%
7/16 • Number of events 7 • 12 weeks
|
|
General disorders
Sleeplessness
|
25.0%
4/16 • Number of events 4 • 12 weeks
|
|
General disorders
Pain
|
18.8%
3/16 • Number of events 3 • 12 weeks
|
|
Metabolism and nutrition disorders
Increased Appetite/Weight Gain
|
31.2%
5/16 • Number of events 5 • 12 weeks
|
|
Gastrointestinal disorders
Gi Distress/Poor Appetite
|
12.5%
2/16 • Number of events 2 • 12 weeks
|
|
General disorders
Cold or Flu Symptoms
|
25.0%
4/16 • Number of events 5 • 12 weeks
|
|
General disorders
Sedation
|
43.8%
7/16 • Number of events 9 • 12 weeks
|
|
Psychiatric disorders
Unusual Dream Activity
|
18.8%
3/16 • Number of events 3 • 12 weeks
|
|
General disorders
Heaviness/Pressure
|
12.5%
2/16 • Number of events 2 • 12 weeks
|
|
General disorders
Dizzy
|
18.8%
3/16 • Number of events 3 • 12 weeks
|
|
Cardiac disorders
Hypertension
|
12.5%
2/16 • Number of events 2 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Stiffness
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
|
General disorders
Fall
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Palpatations
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
|
General disorders
Other
|
25.0%
4/16 • Number of events 7 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place