Trial Outcomes & Findings for Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines (NCT NCT01244711)

Results Overview

For MDD: The primary efficacy measures will be change from baseline to endpoint in the MADRS and the change in mean daily benzodiazepine dose in diazepam equivalents during the past week. Range is 0 (least severe) to 50 (most severe).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

12 weeks

Results posted on

2015-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Quetiapine Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects. quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quetiapine n=1 Participants Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects. quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Change in total score on the MADRS from baseline to final visit

For MDD: The primary efficacy measures will be change from baseline to endpoint in the MADRS and the change in mean daily benzodiazepine dose in diazepam equivalents during the past week. Range is 0 (least severe) to 50 (most severe).

Outcome measures

Outcome measures
Measure	Quetiapine n=1 Participants Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects. quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.
Montgomery Asberg Depression Rating Scale (MADRS)	-12 units on a scale

Adverse Events

Quetiapine

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

james kocsis

Weill Cornell Medical College

Phone: 212-746-5913

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place