Major Depressive DisorderPhase 2NCT00149825
Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
A Phase 2 study testing Escitalopram, CBTI and CTRL in people with Major Depressive Disorder and Insomnia, run by Stanford University at 1 site in United States.
Trial summary
This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder, Insomnia
- What is being tested?
- Escitalopram, CBTI and CTRL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Aug 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of major depressive disorder
- HRSD(17) score of at least 14
- Presence and complaint of insomnia for at least 1 month
- Fluent in English
- Use of an effective form of contraception throughout the study
Who cannot join
- Other psychiatric disorders (e.g., bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, eating disorder)
- Psychotic symptoms
- Serious, unstable, or terminal medical condition
- Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder
- Substance abuse
- Not willing to end other psychiatric treatment
Show all 14Show fewer
- Previous electroconvulsive therapy or vagus nerve stimulation treatment during the last year
- Sleep apnea, restless leg, or periodic limb movement disorder (to be ruled out after first sleep study)
- Other sleep disorders
- Currently pregnant or breastfeeding
- History of seizure disorder
- Disease or condition that produces altered metabolism or hemodynamic responses
- Liver or kidney dysfunction
- Current use of any over the counter medications or herbs for mood or sleep benefits (e.g., melatonin, valerian, kava, hop extract, St. John's Wort, SAMe)
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
Read the detailed description
Difficulties falling and/or staying asleep are common in people who suffer from depression. Persistent insomnia can hinder response to treatment. In addition, individuals whose insomnia does not resolve with standard antidepressant therapy are at increased risk for recurrence of their depression. Between 60% and 84% of people who have major depressive disorder report symptoms of insomnia. This study will assess the efficacy of combining antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
Participants in this double-blind study will be randomly assigned to receive either desensitization therapy or cognitive behavioral therapy to target insomnia. All participants will also receive escitalopram oxalate, an antidepressant medication. The study will last 12 weeks. The severity of participants' depression and insomnia will be assessed. Study visits will occur weekly for the first 6 weeks, bi-weekly for the last 6 weeks, and once 6 months post-intervention.
- Conditions
- Major Depressive Disorder, Insomnia
- Being tested
- Escitalopram, CBTI, CTRL
- Keywords
- Major Depressive Disorder, Insomnia, Sleep, Mental Health
- Medical subject headings
- Depressive Disorder, Major, Sleep Initiation and Maintenance Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Escitalopram plus Cognitive behavioral Therapy, Escitalopram plus Pseudo-desensitization Therapy
5 to 20 mg for 12 weeks
CBTIBehavioural
Also called Cognitive Behavioral Treatment for Insomnia
Cognitive Behavioral Treatment for Insomnia
CTRLBehavioural
Also called Pseudo-desensitization Therapy for Insomnia
Control Therapy consists of Pseudo-desensitization Therapy for Insomnia
| Study group | Role | What they receive |
|---|---|---|
| MED+CBTI | Experimental | Escitalopram plus Cognitive Behavioral Therapy for Insomnia Receives: Drug: Escitalopram; Behavioral: CBTI |
| MED+CTRL | Active comparator | Escitalopram plus Pseudo-desensitization Therapy for Insomnia Receives: Drug: Escitalopram; Behavioral: CTRL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of Depression (%)
Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.
The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.
The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains).
Measured: After 12 weeks or at the last available time point
Secondary outcomes (1)
Remission of Insomnia
Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score < 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score < 8 indicates absence of insomnia.
Measured: After 12 weeks or at the last available time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionAug 2007
- Study completionAug 2007
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 (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rachel Manber, Stanford University
- Investigators
- Rachel Manber, PhD, Principal investigator, Stanford University Medical School, Department of Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149825
- Sponsor's protocol ID
- R21MH066131
- Other IDs
- R21MH066131, DSIR 83-ATAS
- Status last verified
- May 2014
- First submitted
- 6 Sep 2005
- Last updated
- 20 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ong JC, Gress JL, San Pedro-Salcedo MG, Manber R. Frequency and predictors of obstructive sleep apnea among individuals with major depressive disorder and insomnia. J Psychosom Res. 2009 Aug;67(2):135-41. doi: 10.1016/j.jpsychores.2009.03.011. Epub 2009 Apr 25.
PubMed 19616140Manber R, Edinger JD, Gress JL, San Pedro-Salcedo MG, Kuo TF, Kalista T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. Sleep. 2008 Apr;31(4):489-95. doi: 10.1093/sleep/31.4.489.
PubMed 18457236
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
- ClinicalTrials.gov ID
- NCT00149825
- Acronym / sponsor ID
- R21MH066131
- Conditions
- Major Depressive Disorder, Insomnia
- Keywords
- Major Depressive Disorder, Insomnia, Sleep, Mental Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 14 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
Detailed description
Difficulties falling and/or staying asleep are common in people who suffer from depression. Persistent insomnia can hinder response to treatment. In addition, individuals whose insomnia does not resolve with standard antidepressant therapy are at increased risk for recurrence of their depression. Between 60% and 84% of people who have major depressive disorder report symptoms of insomnia. This study will assess the efficacy of combining antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
Participants in this double-blind study will be randomly assigned to receive either desensitization therapy or cognitive behavioral therapy to target insomnia. All participants will also receive escitalopram oxalate, an antidepressant medication. The study will last 12 weeks. The severity of participants' depression and insomnia will be assessed. Study visits will occur weekly for the first 6 weeks, bi-weekly for the last 6 weeks, and once 6 months post-intervention.
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 |
|---|---|---|
| MED+CBTI | Experimental | Drug: Escitalopram, Behavioral: CBTIEscitalopram plus Cognitive Behavioral Therapy for Insomnia |
| MED+CTRL | Active comparator | Drug: Escitalopram, Behavioral: CTRLEscitalopram plus Pseudo-desensitization Therapy for Insomnia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of major depressive disorder
- HRSD(17) score of at least 14
- Presence and complaint of insomnia for at least 1 month
- Fluent in English
- Use of an effective form of contraception throughout the study
Key exclusion criteria (14 listed)
- Other psychiatric disorders (e.g., bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, eating disorder)
- Psychotic symptoms
- Serious, unstable, or terminal medical condition
- Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder
- Substance abuse
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 |
|---|---|---|
| EscitalopramAlso: Escitalopram plus Cognitive behavioral Therapy, Escitalopram plus Pseudo-desensitization Therapy5 to 20 mg for 12 weeks | Drug | MED+CBTI, MED+CTRL |
| CBTIAlso: Cognitive Behavioral Treatment for InsomniaCognitive Behavioral Treatment for Insomnia | Behavioural | MED+CBTI |
| CTRLAlso: Pseudo-desensitization Therapy for InsomniaControl Therapy consists of Pseudo-desensitization Therapy for Insomnia | Behavioural | MED+CTRL |
Primary outcome
Remission of Depression (%)
Time frame: After 12 weeks or at the last available time point
Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID. The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms. The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains).
1 secondary outcome
Remission of Insomnia
Time frame: After 12 weeks or at the last available time point
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19616140Ong JC, Gress JL, San Pedro-Salcedo MG, Manber R. Frequency and predictors of obstructive sleep apnea among individuals with major depressive disorder and insomnia. J Psychosom Res. 2009 Aug;67(2):135-41. doi: 10.1016/j.jpsychores.2009.03.011. Epub 2009 Apr 25.
- Results publication: PubMed 18457236Manber R, Edinger JD, Gress JL, San Pedro-Salcedo MG, Kuo TF, Kalista T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. Sleep. 2008 Apr;31(4):489-95. doi: 10.1093/sleep/31.4.489.
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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, PhD principal investigator
Stanford University Medical School, Department of Psychiatry and Behavioral Sciences
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, CBTI and CTRL in people with Major Depressive Disorder and Insomnia, run by Stanford University 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 5 inclusion and 14 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 20 May 2014. 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. 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 14 Oct 2009). 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?
Remission of Depression (%) (time frame: After 12 weeks or at the last available time point). 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 NCT00149825, which also lists 2 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 20 May 2014.