DepressionPhase 2NCT03388164
Adherence to Antidepressant Treatment in Subjects With Depression
A Phase 2 study testing Escitalopram + RT2CK17 in people with Depression, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Escitalopram + RT2CK17
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 15 May 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Baseline QIDS-SR ≥ 14 (moderate depression)
- Age 18 - 65
- Written Informed Consent
- Major Depressive Disorder, single-episode/recurrent, not in remission
Who cannot join
- RT2CK17-related exclusions
- Uncontrolled hyperthyroidism
- Glaucoma
- Motor tics
- Monoamine oxidase inhibitor treatment
- Serious coronary artery disease, cardiomyopathy, serious cardiac arrhythmias
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
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.
- Conditions
- Depression
- Being tested
- Escitalopram + RT2CK17, Escitalopram + Placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram + RT2CK17Drug
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.
Escitalopram + PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram + RT2CK17 | Active comparator | 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. Receives: Drug: Escitalopram + RT2CK17 |
| Escitalopram + Placebo | Placebo comparator | 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. Receives: Drug: Escitalopram + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (1)
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start1 Jan 2018
- Primary completion15 May 2019
- Study completion15 May 2019
Why it stopped: The study was terminated early based on the planned interim analysis that did not meet criteria for continuation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin P Paulus, M.D., Study director, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388164
- Sponsor's protocol ID
- 2017-007
- Status last verified
- Nov 2020
- First submitted
- 22 Dec 2017
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paulus MP, Kuplicki R, Victor TA, Yeh HW, Khalsa SS. Methylphenidate augmentation of escitalopram to enhance adherence to antidepressant treatment: a pilot randomized controlled trial. BMC Psychiatry. 2021 Nov 19;21(1):582. doi: 10.1186/s12888-021-03583-7.
PubMed 34798853
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Antidepressant Treatment in Subjects With Depression
- ClinicalTrials.gov ID
- NCT03388164
- Acronym / sponsor ID
- 2017-007
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early based on the planned interim analysis that did not meet criteria for continuation.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram + RT2CK17 | Active comparator | Drug: Escitalopram + RT2CK1710mg 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 + Placebo | Placebo comparator | Drug: Escitalopram + Placebo10mg 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Baseline QIDS-SR ≥ 14 (moderate depression)
- Age 18 - 65
- Written Informed Consent
- Major Depressive Disorder, single-episode/recurrent, not in remission
Key exclusion criteria (15 listed)
- RT2CK17-related exclusions
- Uncontrolled hyperthyroidism
- Glaucoma
- Motor tics
- Monoamine oxidase inhibitor treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram + RT2CK17Participants 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. | Drug | Escitalopram + RT2CK17 |
| Escitalopram + PlaceboParticipants 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. | Drug | Escitalopram + Placebo |
Primary outcome
Rate of Adherence
Time frame: 8 weeks
To determine whether RT2CK17 + escitalopram results in higher rates of medication adherence relative to placebo + escitalopram as measured by percentage pill count
1 secondary outcome
Adherence Consistency
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34798853Paulus MP, Kuplicki R, Victor TA, Yeh HW, Khalsa SS. Methylphenidate augmentation of escitalopram to enhance adherence to antidepressant treatment: a pilot randomized controlled trial. BMC Psychiatry. 2021 Nov 19;21(1):582. doi: 10.1186/s12888-021-03583-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin P Paulus, M.D. study director
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Escitalopram + RT2CK17 in people with Depression, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Adherence (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.