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Trial Outcomes & Findings for Pilot Study of Open-label Placebo to Treat Major Depressive Disorder (NCT NCT01103271)

NCT ID: NCT01103271

Last Updated: 2013-01-14

Results Overview

The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

One year

Results posted on

2013-01-14

Participant Flow

A total of 33 participants were screened for this study.

Participant milestones

Participant milestones
Measure
Immediate Treatment
Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
Waitlist Treatment
Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
Overall Study
STARTED
11
9
Overall Study
COMPLETED
10
5
Overall Study
NOT COMPLETED
1
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Open-label Placebo to Treat Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Immediate Treatment
n=11 Participants
Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
Waitlist Treatment
n=9 Participants
Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
Total
n=20 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=99 Participants
9 Participants
n=107 Participants
20 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age Continuous
37.2 years
STANDARD_DEVIATION 12.0 • n=99 Participants
40.8 years
STANDARD_DEVIATION 13.7 • n=107 Participants
38.8 years
STANDARD_DEVIATION 12.6 • n=206 Participants
Sex: Female, Male
Female
8 Participants
n=99 Participants
6 Participants
n=107 Participants
14 Participants
n=206 Participants
Sex: Female, Male
Male
3 Participants
n=99 Participants
3 Participants
n=107 Participants
6 Participants
n=206 Participants
Region of Enrollment
United States
11 participants
n=99 Participants
9 participants
n=107 Participants
20 participants
n=206 Participants

PRIMARY outcome

Timeframe: One year

Population: The number of participants analyzed is the number of participants screened.

The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.

Outcome measures

Outcome measures
Measure
Placebo Effect Study
n=33 Participants
These were all participants who were screened for the study but not yet enrolled.
Placebo Comparator: Waitlist Treatment
Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
Feasibility
33 screens
0
—

SECONDARY outcome

Timeframe: Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment)

The magnitude of the pre-post effect across 4 weeks of treatment, as measured by the Hamilton Rating Scale for Depression-17 (HAMD-17). The HAMD-17 measures depression severity, and has a minimum value of 0 and a maximum value of 52 units on a scale, where higher scores indicate more severe depression.

Outcome measures

Outcome measures
Measure
Placebo Effect Study
n=11 Participants
These were all participants who were screened for the study but not yet enrolled.
Placebo Comparator: Waitlist Treatment
n=9 Participants
Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
Pre-Post Efficacy
14.75 units on a scale
Standard Deviation 6.61
3.25 units on a scale
Standard Deviation 6.01

Adverse Events

Immediate Treatment

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

Waitlist Treatment

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. Maurizio Fava

Massachusetts General Hospital

Phone: 617-724-0838

Results disclosure agreements

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