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Trial Outcomes & Findings for Seroquel in the Treatment of Dysphoric Hypomania in Bipolar II (NCT NCT00186043)

NCT ID: NCT00186043

Last Updated: 2017-09-27

Results Overview

0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

55 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2017-09-27

Participant Flow

Participant milestones

Participant milestones
Measure
Quetiapine/Seroquel
Quetiapine/Seroquel up to 800 mg/day Quetiapine/Seroquel: Quetiapine/Seroquel
Placebo
Placebo
Overall Study
STARTED
30
25
Overall Study
COMPLETED
15
12
Overall Study
NOT COMPLETED
15
13

Reasons for withdrawal

Reasons for withdrawal
Measure
Quetiapine/Seroquel
Quetiapine/Seroquel up to 800 mg/day Quetiapine/Seroquel: Quetiapine/Seroquel
Placebo
Placebo
Overall Study
Lack of Efficacy
1
3
Overall Study
Lost to Follow-up
4
6
Overall Study
Withdrawal by Subject
1
0
Overall Study
Adverse Event
7
3
Overall Study
Protocol Violation
2
1

Baseline Characteristics

Seroquel in the Treatment of Dysphoric Hypomania in Bipolar II

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Quetiapine/Seroquel
n=30 Participants
Quetiapine/Seroquel up to 800 mg/day Quetiapine/Seroquel: Quetiapine/Seroquel
Placebo
n=25 Participants
Placebo
Total
n=55 Participants
Total of all reporting groups
Age, Continuous
38.5 years
STANDARD_DEVIATION 11.4 • n=5 Participants
38.1 years
STANDARD_DEVIATION 11.1 • n=7 Participants
38.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
20 Participants
n=7 Participants
42 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
5 Participants
n=7 Participants
13 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
27 Participants
n=5 Participants
20 Participants
n=7 Participants
47 Participants
n=5 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Other
3 Participants
n=5 Participants
5 Participants
n=7 Participants
8 Participants
n=5 Participants
Region of Enrollment
United States
30 participants
n=5 Participants
25 participants
n=7 Participants
55 participants
n=5 Participants
Clinical Global Impression for Bipolar Disorders Overall Severity
4.3 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
4.4 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
4.3 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
MADRS
27.3 units on a scale
STANDARD_DEVIATION 7.7 • n=5 Participants
29.1 units on a scale
STANDARD_DEVIATION 7.5 • n=7 Participants
28.1 units on a scale
STANDARD_DEVIATION 7.6 • n=5 Participants
YMRS
21.6 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
20.0 units on a scale
STANDARD_DEVIATION 3.9 • n=7 Participants
20.9 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
GAF
55.3 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
56.8 units on a scale
STANDARD_DEVIATION 4.7 • n=7 Participants
56.0 units on a scale
STANDARD_DEVIATION 4.6 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: One participant randomized to the Placebo group did not complete any post-baseline visits and is not included in the analysis.

0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days.

Outcome measures

Outcome measures
Measure
Quetiapine/Seroquel
n=30 Participants
Quetiapine/Seroquel up to 800 mg/day Quetiapine/Seroquel: Quetiapine/Seroquel
Placebo
n=24 Participants
Placebo comparator
Percentage of Participants With >=50% Improvement From Baseline in Clinical Global Impression for Bipolar Disorders Overall Severity
37 percentage of participants
21 percentage of participants

PRIMARY outcome

Timeframe: Week 8

Population: One participant randomized to the Placebo group did not complete any post-baseline visits and is not included in the analysis.

0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days.

Outcome measures

Outcome measures
Measure
Quetiapine/Seroquel
n=30 Participants
Quetiapine/Seroquel up to 800 mg/day Quetiapine/Seroquel: Quetiapine/Seroquel
Placebo
n=24 Participants
Placebo comparator
Percentage of Participants With Clinical Global Impression for Bipolar Disorders Overall Severity Remission (Score <=2 at Week 8)
47 percentage of participants
21 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: One participant randomized to the Placebo group did not complete any post-baseline visits and is not included in the analysis.

MADRS assesses change from baseline to endpoint. Higher score indicates more severe depression; each item yields a score of 0 to 6. Overall score ranges: 0 to 60. Questions following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Cutoff points:0 to 6- normal/symptom absent; 7 to 19- mild depression; 20 to 34- moderate depression; \>34- severe depression. YMRS:a 11-item clinician-admin instrument assesses severity of mania. Symptoms rated: Elevated mood, Increased motor activity/energy, Sexual interest, Sleep, irritability, Speech, language/thought disorder, Content, Disruptive/aggressive behavior, Appearance, Insight. Each composed of five explicitly defined levels of severity. Severity ratings based on patient's subjective report of clinical condition during past 48 hours and clinician's observations.

Outcome measures

Outcome measures
Measure
Quetiapine/Seroquel
n=30 Participants
Quetiapine/Seroquel up to 800 mg/day Quetiapine/Seroquel: Quetiapine/Seroquel
Placebo
n=24 Participants
Placebo comparator
Percentage of Participants With 50% Improvement From Baseline in Both Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) Scores
47 percentage of participants
29 percentage of participants

Adverse Events

Quetiapine/Seroquel

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Quetiapine/Seroquel
n=30 participants at risk
Quetiapine/Seroquel up to 800 mg/day Quetiapine/Seroquel: Quetiapine/Seroquel
Placebo
n=25 participants at risk
Placebo Quetiapine/Seroquel: Quetiapine/Seroquel
Nervous system disorders
Sedation/somnolence
3.3%
1/30 • 8 weeks.
0.00%
0/25 • 8 weeks.
Cardiac disorders
Heart Palpitation
3.3%
1/30 • 8 weeks.
0.00%
0/25 • 8 weeks.
General disorders
minor illness-unspecified
6.7%
2/30 • 8 weeks.
20.0%
5/25 • 8 weeks.
Psychiatric disorders
significant drug and alcohol use
3.3%
1/30 • 8 weeks.
0.00%
0/25 • 8 weeks.
General disorders
medication side effect-unspecified
0.00%
0/30 • 8 weeks.
4.0%
1/25 • 8 weeks.

Additional Information

Trisha Suppes MD, PhD

Bipolar and Depression Research Program, Stanford University, School of Medicine, VA Palo Alto Health Care System

Phone: 6504962567

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place