Trial Outcomes & Findings for Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety (NCT NCT00746239)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

10 weeks

Results posted on

2018-05-30

Participant Flow

11 subjects total were enrolled in the study. It was a double blind study, however, the blind was never opened as the study was terminated prematurely due to lack of continued funding. Thus, subjects in each arm are not known. Out of the 11 subjects enrolled, 6 withdrew from the study and 5 completed the study.

Participant milestones

Participant milestones
Measure	PD Subjects With Either Escitalopram and Placebo OR Ramelteon Subjects were randomly assigned to receive either Ramelteon 8 mg and Escitalopram (5-40 mg) OR Placebo and Escitalopram (5-40 mg). However, as the blind was never opened, we are combining all subjects in one group for presenting in this record.
Overall Study STARTED	11
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PD Subjects With Either Escitalopram and Placebo OR Ramelteon n=11 Participants Panic disorder subjects who were on Escitalopram (5-40 mg) received either Ramelteon 8 mg OR Placebo. As the study was terminated prematurely, the blind was never opened. Thus, it is not known as to how many were in each arm. As a result we are combining all subjects in one group for presenting in this record.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome data not reported

Adverse Events

PD Subjects With Either Escitalopram and Placebo OR Ramelteon

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PD Subjects With Either Escitalopram and Placebo OR Ramelteon n=11 participants at risk Panic disorder subjects who were on Escitalopram received either Escitalopram OR Placebo - as the study terminated prematurely, the blind was never opened; thus it is not known as to how many were in each arm- as a result we are not combining all in one group for presenting in this record. Ramelteon and Escitalopram: Ramelteon 8 mg and Escitalopram (5-40 mg)
Nervous system disorders extreme drowsiness and difficult focussing	9.1% 1/11 • 2 years 2 months

Additional Information

Ravi Singareddy

Penn State Hershey Medical Center

Phone: 717-531-0040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place