Depression
Conditions
Brief summary
This study aims to determine whether a combination a first-line antidepressant plus RT2CK17 in a capsule relative to a first-line antidepressant plus placebo in a capsule results in higher rates of medication adherence in individuals with moderate to severe depression. In this double-blind randomized placebo controlled trial, 100 individuals with a Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) scale score ≥ 14 will be enrolled to participate in an 8 week treatment study. Participants will be randomized with a 1-1 ratio to receive 5 milligrams (mg) RT2CK17 + 10 mg escitalopram or placebo + 10 mg escitalopram to be taken orally once per day. Participants will undergo a 3 hour baseline evaluation visit at week 0, two 30-minute office visits (week 2 and 4), one 60-minute office visit (week 8) and three 5-minute phone calls (weeks 1, 3, and 6) during which clinical assessments and measures will be obtained. The trial is designed with two stages: 20 participants in Stage 1 will be used to estimate the adherence effect size; Stage 2 is designed with an interim analysis to test our hypotheses.
Interventions
DRUGEscitalopram + RT2CK17
Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6.
Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6.
Sponsors
Laureate Institute for Brain Research, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Baseline QIDS-SR ≥ 14 (moderate depression) * Age 18 - 65 * Written Informed Consent * Major Depressive Disorder, single-episode/recurrent, not in remission
Exclusion criteria
* RT2CK17-related exclusions * Uncontrolled hyperthyroidism * Glaucoma * Motor tics * Monoamine oxidase inhibitor treatment * Serious coronary artery disease, cardiomyopathy, serious cardiac arrhythmias * Uncontrolled hypertension * Peripheral vasculopathy * Pregnancy * Bipolar Disorder * Psychotic Disorder * History of intolerability of study medications * Currently taking psychiatric medications * Current Substance Use Disorder (other than nicotine) * Current Alcohol Use Disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adherence | 8 weeks | To determine whether RT2CK17 + escitalopram results in higher rates of medication adherence relative to placebo + escitalopram as measured by percentage pill count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence Consistency | 8 weeks | To determine whether RT2CK17 + escitalopram results in greater consistency of adherence relative to placebo + escitalopram as measured by percentage of doses taken on schedule within 25% of the expected time interval, defined as +/- 6 hours from the participant's breakfast time |
Countries
United States
Participant flow
Pre-assignment details
Three individuals were excluded prior to group assignment: 2- did not meet inclusion criteria (alcohol use, low TSH) 1- declined to participate
Participants by arm
| Arm | Count |
|---|---|
| Escitalopram + RT2CK17 10mg escitalopram + 5mg RT2CK17 will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the placebo comparator by a local compounding pharmacy in Tulsa, Oklahoma.
Escitalopram + RT2CK17: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6. | 10 |
| Escitalopram + Placebo 10mg escitalopram + 5mg placebo will be given orally and encapsulated into one capsule, once per day for 8 weeks. The capsules will be produced in the same manner as the active comparator by a local compounding pharmacy in Tulsa, Oklahoma.
Escitalopram + Placebo: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Escitalopram + Placebo | Total | Escitalopram + RT2CK17 |
|---|---|---|---|
| Age, Continuous | 31.0 years STANDARD_DEVIATION 10.6 | 31.3 years STANDARD_DEVIATION 10.4 | 31.5 years STANDARD_DEVIATION 10.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Female | 8 Participants | 15 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Rate of Adherence
To determine whether RT2CK17 + escitalopram results in higher rates of medication adherence relative to placebo + escitalopram as measured by percentage pill count
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram + RT2CK17 | Rate of Adherence | 93.5 percentage of pills taken | Standard Deviation 7.6 |
| Escitalopram + Placebo | Rate of Adherence | 97.6 percentage of pills taken | Standard Deviation 6.5 |
Secondary
Adherence Consistency
To determine whether RT2CK17 + escitalopram results in greater consistency of adherence relative to placebo + escitalopram as measured by percentage of doses taken on schedule within 25% of the expected time interval, defined as +/- 6 hours from the participant's breakfast time
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Escitalopram + RT2CK17 | Adherence Consistency | 89.8 percentage of pills taken on time | Standard Deviation 8.2 |
| Escitalopram + Placebo | Adherence Consistency | 93.6 percentage of pills taken on time | Standard Deviation 8.4 |