Trial Outcomes & Findings for Neurobiological Bases of Placebo Response in Major Depressive Disorder (NCT NCT01787240)

Last Updated: 2017-05-16

Results Overview

We will measure the percentage of screened eligible patients who agree to be randomized. Participants were assessed for this Outcome Measure before randomization.This would occur at the first study visit (screening).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

This would occur at the first study visit (screening).

Results posted on

2017-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo. Placebo	Escitalopram 10mg After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo. Escitalopram 10mg
Overall Study STARTED	15	5
Overall Study COMPLETED	10	4
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neurobiological Bases of Placebo Response in Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=15 Participants After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo. Placebo	Escitalopram 10mg n=5 Participants After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo. Escitalopram 10mg	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32.6 Years STANDARD_DEVIATION 14.10 • n=5 Participants	33 Years STANDARD_DEVIATION 11.64 • n=7 Participants	32.7 Years STANDARD_DEVIATION 13.23 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	5 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: This would occur at the first study visit (screening).

Outcome measures

Outcome measures
Measure	Eligible Patients n=21 Participants Number of patients who were screened and were determined to be eligible for the study.	Phase 2 Active Participants assigned to take active drug who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
Feasibility	95.2 percent of eligible patients	—

SECONDARY outcome

Timeframe: Baseline, Visit 10 (after 9 weeks in study)

Population: Participants assigned to take either active drug or placebo who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.

We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests. The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression. A negative change value refers to a decrease in HAM D score.

Outcome measures

Outcome measures
Measure	Eligible Patients n=6 Participants Number of patients who were screened and were determined to be eligible for the study.	Phase 2 Active n=3 Participants Participants assigned to take active drug who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
Effects of Acute Tryptophan Depletion on Mood	-6.0 units on a scale Standard Deviation 6.4	-13.0 units on a scale Standard Deviation 12.1

SECONDARY outcome

Timeframe: Baseline, Visit 5 (4 weeks into study)

Population: Patients who were randomized to take placebo or active drug

Outcome measures

Outcome measures
Measure	Eligible Patients n=12 Participants Number of patients who were screened and were determined to be eligible for the study.	Phase 2 Active n=4 Participants Participants assigned to take active drug who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
Effects of Acute Tryptophan Depletion on Mood	-6.4 units on a scale Standard Deviation 8.5	-8.8 units on a scale Standard Deviation 6.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 5 (after 4 weeks in study) or Visit 10 (after 9 weeks in study)

Population: Data were not collected

We will examine percentage changes in serotonin binding potential before and after acute tryptophan depletion within each region of interest. We will examine differences in serotonin binding potential between placebo responders and drug responders using a paired two-tailed t-test. Data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Escitalopram 10mg

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=15 participants at risk After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo. Placebo	Escitalopram 10mg n=5 participants at risk After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo. Escitalopram 10mg
Gastrointestinal disorders Diarrhea	0.00% 0/15 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	20.0% 1/5 • Number of events 2 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Cardiac disorders Chest pain	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Ear and labyrinth disorders Tinnitus	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Gastrointestinal disorders Dry mouth	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Infections and infestations Upper respiratory infection	0.00% 0/15 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	20.0% 1/5 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Infections and infestations Pancreatitis/Influenza	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.

Other adverse events

Additional Information

Dr. Cristina Cusin

MGH

Phone: 617 726 6421

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=15 participants at risk After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo. Placebo	Escitalopram 10mg n=5 participants at risk After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo. Escitalopram 10mg
Nervous system disorders Headache	20.0% 3/15 • Number of events 5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	20.0% 1/5 • Number of events 2 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Gastrointestinal disorders Diarrhea	13.3% 2/15 • Number of events 2 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	20.0% 1/5 • Number of events 2 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Gastrointestinal disorders Gas/irregular Bowels	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Psychiatric disorders Anxiety attack	20.0% 3/15 • Number of events 3 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Nervous system disorders Sleep paralysis	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Nervous system disorders Insomnia	13.3% 2/15 • Number of events 2 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Vascular disorders Hypotension	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Nervous system disorders Dizziness	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Gastrointestinal disorders Nausea	26.7% 4/15 • Number of events 4 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Cardiac disorders Chest pain/pressure	6.7% 1/15 • Number of events 2 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Ear and labyrinth disorders Tinnitus	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Gastrointestinal disorders Constipation	13.3% 2/15 • Number of events 3 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Gastrointestinal disorders Acid reflux	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Musculoskeletal and connective tissue disorders Arthritis	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Psychiatric disorders Irritability	13.3% 2/15 • Number of events 2 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Psychiatric disorders Memory issues	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Nervous system disorders Fatigue	6.7% 1/15 • Number of events 2 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Psychiatric disorders Emotional lability	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
General disorders Dry mouth	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Cardiac disorders Heart palpitations	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Infections and infestations Cold/sinus infection	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Gastrointestinal disorders Bloated	6.7% 1/15 • Number of events 2 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Psychiatric disorders Sexual Interest/Libido	6.7% 1/15 • Number of events 5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.
Musculoskeletal and connective tissue disorders Shoulder pain/numbness	6.7% 1/15 • Number of events 1 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.	0.00% 0/5 • The adverse event data were collected over the duration of the study, which lasted 2 years and 6 months.