Trial Outcomes & Findings for Treatment Study of Bipolar Depression (NCT NCT00947791)

NCT ID: NCT00947791

Last Updated: 2017-05-17

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

24 hrs post-infusion compared to baseline

Results posted on

2017-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine/Midazolam Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg	Midazolam/Ketamine Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment Study of Bipolar Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine/Midazolam Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg	Midazolam/Ketamine Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg	Total Total of all reporting groups
Sex: Female, Male Female	—	—	0 n=5 Participants
Sex: Female, Male Male	—	—	0 n=5 Participants

PRIMARY outcome

Timeframe: 24 hrs post-infusion compared to baseline

Population: Based on confidentiality concerns, 0 participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hrs post-infusion compared to baseline

Population: Based on confidentiality concerns, 0 participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hrs post-infusion compared to baseline

Population: Based on confidentiality concerns, 0 participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 hrs post-infusion compared to baseline

Population: Based on confidentiality concerns, 0 participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 hrs post-infusion compared to baseline

Population: Based on confidentiality concerns, 0 participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 hrs post-infusion compared to baseline

Population: Based on confidentiality concerns, 0 participants analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Ketamine/Midazolam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam/Ketamine

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

Dr. James W. Murrough

Icahn School of Medicine at Mount Sinai

Phone: 212-241-6539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place