Sleep Initiation and Maintenance DisordersPhase 2/3NCT00767624
TRIAD - Treatment of Insomnia and Depression
A Phase 2/3 study testing Antidepressant, Desensitization Therapy for Insomnia and Cognitive Behavioral Therapy for Insomnia in people with Sleep Initiation and Maintenance Disorders and Depression, run by Stanford University at 3 sites in United States.
Trial summary
The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Depression
- What is being tested?
- Antidepressant, Desensitization Therapy for Insomnia and Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2008to Jun 2015
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets criteria for Major Depressive Disorder
- Between 18 and 75 years of age and adequately fluent in English
- Meets criteria for an insomnia disorder
Who cannot join
- Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.
- People for whom the antidepressant medication(s) provided in the study is not indicated
- People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.
- People with uncontrolled medical conditions.
- People with moderate or severe sleep disorders other than insomnia
- Individuals on a fixed night shift or rotating work schedule that requires a night shift.
- Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University
Durham, North Carolina
University of Pittsburgh
Pittsburgh, Pennsylvania
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants
The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia.
Read the detailed description
Participants with major depressive disorder and insomnia who meet all study criteria will receive state-of-the-art antidepressant medications and one of two insomnia therapies. The specific therapy for insomnia will be determined by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or desensitization psychotherapy for insomnia. The study physician will select an initial antidepressant medication from a list of three possible medications . If that medication is not helpful, another medication may be tried after 8 weeks or in the event of severe side effects.
- Being tested
- Antidepressant, Desensitization Therapy for Insomnia, Cognitive Behavioral Therapy for Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntidepressantDrug
Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Desensitization Therapy for InsomniaBehavioural
Cognitive Behavioral Therapy for InsomniaBehavioural
| Study group | Role | What they receive |
|---|---|---|
| antidepressant + desensitization | Other | Combined antidepressant medication (determined by an algorithm) plus desensitization therapy Receives: Drug: Antidepressant; Behavioral: Desensitization Therapy for Insomnia |
| antidepressant + cognitive behavioral | Other | Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy Receives: Drug: Antidepressant; Behavioral: Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With Depression Remission
Depression remission was defined if both a and b below are satisfied
- absence of both depressed mood and anhedonia for at least three consecutive weeks
- no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks
Measured: 16 weeks
Secondary outcomes (1)
Percentage of Participants in Insomnia Remission
Remission was defined as endpoint ISI<8. The ISI scale score ranges from 0 to 28 with lower scores representing less severe insomnia. A score of 0-7 is interpreted as absence of insomnia.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2015
- Study completionJun 2015
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 (5)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, University of Pittsburgh, University of Pennsylvania
- Responsible party
- Principal investigator, Rachel Manber, Stanford University
- Investigators
- Rachel Manber, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767624
- Sponsor's protocol ID
- SU-08132008-1277
- Other IDs
- MH78924
- Status last verified
- Oct 2016
- First submitted
- 3 Oct 2008
- Last updated
- 5 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Spina MA, Bei B, Rajaratnam SW, Krystal A, Edinger JD, Buysse DJ, Thase M, Manber R. Cognitive behavioural therapy for insomnia reduces actigraphy and diary measured sleep discrepancy for individuals with comorbid insomnia and major depressive disorder: A report from the TRIAD study. Sleep Med. 2024 Feb;114:137-144. doi: 10.1016/j.sleep.2023.12.014. Epub 2023 Dec 24.
PubMed 38183804Edinger JD, Smith ED, Buysse DJ, Thase M, Krystal AD, Wiskniewski S, Manber R. Objective sleep duration and response to combined pharmacotherapy and cognitive behavioral insomnia therapy among patients with comorbid depression and insomnia: a report from the TRIAD study. J Clin Sleep Med. 2023 Jun 1;19(6):1111-1120. doi: 10.5664/jcsm.10514.
PubMed 36798983Asarnow LD, Bei B, Krystal A, Buysse DJ, Thase ME, Edinger JD, Manber R. Circadian Preference as a Moderator of Depression Outcome Following Cognitive Behavioral Therapy for Insomnia Plus Antidepressant Medications: A Report From the TRIAD Study. J Clin Sleep Med. 2019 Apr 15;15(4):573-580. doi: 10.5664/jcsm.7716.
PubMed 30952216Bei B, Asarnow LD, Krystal A, Edinger JD, Buysse DJ, Manber R. Treating insomnia in depression: Insomnia related factors predict long-term depression trajectories. J Consult Clin Psychol. 2018 Mar;86(3):282-293. doi: 10.1037/ccp0000282.
PubMed 29504795Manber R, Buysse DJ, Edinger J, Krystal A, Luther JF, Wisniewski SR, Trockel M, Kraemer HC, Thase ME. Efficacy of Cognitive-Behavioral Therapy for Insomnia Combined With Antidepressant Pharmacotherapy in Patients With Comorbid Depression and Insomnia: A Randomized Controlled Trial. J Clin Psychiatry. 2016 Oct;77(10):e1316-e1323. doi: 10.4088/JCP.15m10244.
PubMed 27788313
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants
- ClinicalTrials.gov ID
- NCT00767624
- Acronym / sponsor ID
- SU-08132008-1277
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Duke University, University of Pittsburgh, University of Pennsylvania
- Study start
- Dec 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Posted 5 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia.
Detailed description
Participants with major depressive disorder and insomnia who meet all study criteria will receive state-of-the-art antidepressant medications and one of two insomnia therapies. The specific therapy for insomnia will be determined by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or desensitization psychotherapy for insomnia. The study physician will select an initial antidepressant medication from a list of three possible medications . If that medication is not helpful, another medication may be tried after 8 weeks or in the event of severe side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antidepressant + desensitization | Other | Drug: Antidepressant, Behavioral: Desensitization Therapy for InsomniaCombined antidepressant medication (determined by an algorithm) plus desensitization therapy |
| antidepressant + cognitive behavioral | Other | Drug: Antidepressant, Behavioral: Cognitive Behavioral Therapy for InsomniaCombined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets criteria for Major Depressive Disorder
- Between 18 and 75 years of age and adequately fluent in English
- Meets criteria for an insomnia disorder
Key exclusion criteria (7 listed)
- Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.
- People for whom the antidepressant medication(s) provided in the study is not indicated
- People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.
- People with uncontrolled medical conditions.
- People with moderate or severe sleep disorders other than insomnia
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 |
|---|---|---|
| AntidepressantPossible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance | Drug | antidepressant + cognitive behavioral, antidepressant + desensitization |
| Desensitization Therapy for Insomnia | Behavioural | antidepressant + desensitization |
| Cognitive Behavioral Therapy for Insomnia | Behavioural | antidepressant + cognitive behavioral |
Primary outcome
Percent of Participants With Depression Remission
Time frame: 16 weeks
Depression remission was defined if both a and b below are satisfied 1. absence of both depressed mood and anhedonia for at least three consecutive weeks 2. no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks
1 secondary outcome
Percentage of Participants in Insomnia Remission
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38183804Spina MA, Bei B, Rajaratnam SW, Krystal A, Edinger JD, Buysse DJ, Thase M, Manber R. Cognitive behavioural therapy for insomnia reduces actigraphy and diary measured sleep discrepancy for individuals with comorbid insomnia and major depressive disorder: A report from the TRIAD study. Sleep Med. 2024 Feb;114:137-144. doi: 10.1016/j.sleep.2023.12.014. Epub 2023 Dec 24.
- Derived from this study: PubMed 36798983Edinger JD, Smith ED, Buysse DJ, Thase M, Krystal AD, Wiskniewski S, Manber R. Objective sleep duration and response to combined pharmacotherapy and cognitive behavioral insomnia therapy among patients with comorbid depression and insomnia: a report from the TRIAD study. J Clin Sleep Med. 2023 Jun 1;19(6):1111-1120. doi: 10.5664/jcsm.10514.
- Derived from this study: PubMed 30952216Asarnow LD, Bei B, Krystal A, Buysse DJ, Thase ME, Edinger JD, Manber R. Circadian Preference as a Moderator of Depression Outcome Following Cognitive Behavioral Therapy for Insomnia Plus Antidepressant Medications: A Report From the TRIAD Study. J Clin Sleep Med. 2019 Apr 15;15(4):573-580. doi: 10.5664/jcsm.7716.
- Derived from this study: PubMed 29504795Bei B, Asarnow LD, Krystal A, Edinger JD, Buysse DJ, Manber R. Treating insomnia in depression: Insomnia related factors predict long-term depression trajectories. J Consult Clin Psychol. 2018 Mar;86(3):282-293. doi: 10.1037/ccp0000282.
- Derived from this study: PubMed 27788313Manber R, Buysse DJ, Edinger J, Krystal A, Luther JF, Wisniewski SR, Trockel M, Kraemer HC, Thase ME. Efficacy of Cognitive-Behavioral Therapy for Insomnia Combined With Antidepressant Pharmacotherapy in Patients With Comorbid Depression and Insomnia: A Randomized Controlled Trial. J Clin Psychiatry. 2016 Oct;77(10):e1316-e1323. doi: 10.4088/JCP.15m10244.
- 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.
Rachel Manber principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Antidepressant, Desensitization Therapy for Insomnia and Cognitive Behavioral Therapy for Insomnia in people with Sleep Initiation and Maintenance Disorders and Depression, run by Stanford University at 3 sites 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 5 Dec 2016). 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?
Percent of Participants With Depression Remission (time frame: 16 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 NCT00767624, which also lists 5 linked publications.
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 5 Dec 2016.