Seasonal Affective DisorderPhase 4SAM-SADNCT00502320
Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder
A Phase 4 study testing Ramelteon in people with Seasonal Affective Disorder, run by Lehigh Valley Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether treating sleep difficulties in patients with seasonal affective disorder also improves their depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Affective Disorder
- What is being tested?
- Ramelteon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2008
- Phase
- Phase 4
- 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
- Male or female age 18-65 yrs.
- A diagnosis of seasonal affective disorder
- A Pittsburgh Sleep Quality Index >5
- English speaking
- Be able to sign informed consent
Who cannot join
- Active substance abuse
- Current psychotic symptoms
- Severe personality disorders
- Primary sleep disorders
- Severe chronic obstructive pulmonary disease (COPD)
- Prescription fluvoxamine(Luvox) use
Trial locations and contacts
1 site in 1 country.
United States1 site
Lehigh Valley Hospital, Department of Psychiatry
Allentown, Pennsylvania, 18103
About this study
Official title: Randomized Placebo-Controlled Trial of Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder
The purpose of this study is to determine whether treating sleep difficulties in patients with seasonal affective disorder also improves their depressive symptoms.
Read the detailed description
Seasonal affective disorder(SAD) is a type of depression in which a patient's depressive symptoms worsen in the winter. These patients' depressive symptoms often lessen in the spring and summer months. Much of the focus of the treatment of SAD (light therapy and melatonin) has involved the brain's suprachiasmatic nucleus(SCN), as it is hypothesized that one potential reason for SAD is a desynchronized SCN. Ramelteon offers a new and more pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon for this patient population may improve sleep, and in addition, do so in a manner that may also reduce their seasonal affective depressive symptoms. Patients eligible for enrollment will be administered either ramelteon or placebo and return to the study office for 4 monthly visits over the winter months, to evaluate the effects of ramelteon versus placebo on sleep and mood.
- Conditions
- Seasonal Affective Disorder
- Being tested
- Ramelteon, Placebo
- Keywords
- Seasonal Affective Disorder, Ramelteon, Psychiatry, Randomized Controlled Trial, Hamilton Depression Rating Scale- SAD Version, Circadian Rhythm
- Medical subject headings
- Seasonal Affective Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamelteonDrug
Also called Rozerem
one 8 mg tablet at bed for up to 4 months
PlaceboDrug
one tablet at bedtime for up to 4 months
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon | Experimental | 8 mg Receives: Drug: Ramelteon |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)
Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Score ranges from 0-21, higher scores represent more significant sleep disturbance.
Measured: Monthly for duration of treatment (up to 4 months)
Secondary outcomes (2)
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)
Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression.
Measured: Monthly for duration of treatment (up to 4 months)
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)
Clinician-rated measure of mood; evaluates classical 21 Hamilton Depression items, and 8-item subscale measuring atypical depression symptoms which commonly occur during SAD episodes. Score ranges from 0-89, higher scores indicate higher levels of depression.
Measured: Monthly for duration of treatment (up to 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startSep 2006
- Primary completionApr 2008
- Study completionJul 2008
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 (34)Papers the sponsor has linked to this study.
- Other trials for Seasonal Affective DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Investigators
- Edward R. Norris, MD, Principal investigator, Lehigh Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502320
- Sponsor's protocol ID
- 06-006R
- Acronym
- SAM-SAD
- Status last verified
- Oct 2009
- First submitted
- 13 Jul 2007
- Last updated
- 6 Oct 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Avery DH, Eder DN, Bolte MA, Hellekson CJ, Dunner DL, Vitiello MV, Prinz PN. Dawn simulation and bright light in the treatment of SAD: a controlled study. Biol Psychiatry. 2001 Aug 1;50(3):205-16. doi: 10.1016/s0006-3223(01)01200-8.
PubMed 11513820Biggs JT, Wylie LT, Ziegler VE. Validity of the Zung Self-rating Depression Scale. Br J Psychiatry. 1978 Apr;132:381-5. doi: 10.1192/bjp.132.4.381.
PubMed 638392Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8.
PubMed 1947597Desan PH, Weinstein AJ, Michalak EE, Tam EM, Meesters Y, Ruiter MJ, Horn E, Telner J, Iskandar H, Boivin DB, Lam RW. A controlled trial of the Litebook light-emitting diode (LED) light therapy device for treatment of Seasonal Affective Disorder (SAD). BMC Psychiatry. 2007 Aug 7;7:38. doi: 10.1186/1471-244X-7-38.
PubMed 17683643Dubocovich ML, Rivera-Bermudez MA, Gerdin MJ, Masana MI. Molecular pharmacology, regulation and function of mammalian melatonin receptors. Front Biosci. 2003 Sep 1;8:d1093-108. doi: 10.2741/1089.
PubMed 12957828Gentili A, Weiner DK, Kuchibhatla M, Edinger JD. Test-retest reliability of the Pittsburgh sleep quality index in nursing home residents. J Am Geriatr Soc. 1995 Nov;43(11):1317-8. doi: 10.1111/j.1532-5415.1995.tb07415.x. No abstract available.
PubMed 7594173Golden RN, Gaynes BN, Ekstrom RD, Hamer RM, Jacobsen FM, Suppes T, Wisner KL, Nemeroff CB. The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence. Am J Psychiatry. 2005 Apr;162(4):656-62. doi: 10.1176/appi.ajp.162.4.656.
PubMed 15800134Hellpach, W.H. (1911). Die geopsychischen erschelnungen; Wetter und klima und landschaft in ihrem einfluss auf das seelenleben. Leipzig: W. Engelmann.
Jenner FA. Chronobiology and the clinical psychiatrist: the current position. Chronobiologia. 1974 Apr-Jun;1(2):151-60. No abstract available.
PubMed 4617659Lam RW, Gorman CP, Michalon M, Steiner M, Levitt AJ, Corral MR, Watson GD, Morehouse RL, Tam W, Joffe RT. Multicenter, placebo-controlled study of fluoxetine in seasonal affective disorder. Am J Psychiatry. 1995 Dec;152(12):1765-70. doi: 10.1176/ajp.152.12.1765.
PubMed 8526243Levitt AJ, Lam RW, Levitan R. A comparison of open treatment of seasonal major and minor depression with light therapy. J Affect Disord. 2002 Sep;71(1-3):243-8. doi: 10.1016/s0165-0327(01)00397-4.
PubMed 12167524Lewy AJ, Sack RL. The phase-shift hypothesis of seasonal affective disorder. Am J Psychiatry. 1988 Aug;145(8):1041-3. doi: 10.1176/ajp.145.8.1041c. No abstract available.
PubMed 3394867Lewy AJ, Lefler BJ, Emens JS, Bauer VK. The circadian basis of winter depression. Proc Natl Acad Sci U S A. 2006 May 9;103(19):7414-9. doi: 10.1073/pnas.0602425103. Epub 2006 Apr 28.
PubMed 16648247Liu C, Weaver DR, Jin X, Shearman LP, Pieschl RL, Gribkoff VK, Reppert SM. Molecular dissection of two distinct actions of melatonin on the suprachiasmatic circadian clock. Neuron. 1997 Jul;19(1):91-102. doi: 10.1016/s0896-6273(00)80350-5.
PubMed 9247266
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled Trial of Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder
- ClinicalTrials.gov ID
- NCT00502320
- Acronym / sponsor ID
- SAM-SAD / 06-006R
- Conditions
- Seasonal Affective Disorder
- Keywords
- Seasonal Affective Disorder, Ramelteon, Psychiatry, Randomized Controlled Trial, Hamilton Depression Rating Scale- SAD Version, Circadian Rhythm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Sep 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 17 Jul 2007 (estimated)
- Results
- Posted 5 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether treating sleep difficulties in patients with seasonal affective disorder also improves their depressive symptoms.
Detailed description
Seasonal affective disorder(SAD) is a type of depression in which a patient's depressive symptoms worsen in the winter. These patients' depressive symptoms often lessen in the spring and summer months. Much of the focus of the treatment of SAD (light therapy and melatonin) has involved the brain's suprachiasmatic nucleus(SCN), as it is hypothesized that one potential reason for SAD is a desynchronized SCN. Ramelteon offers a new and more pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon for this patient population may improve sleep, and in addition, do so in a manner that may also reduce their seasonal affective depressive symptoms. Patients eligible for enrollment will be administered either ramelteon or placebo and return to the study office for 4 monthly visits over the winter months, to evaluate the effects of ramelteon versus placebo on sleep and mood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ramelteon | Experimental | Drug: Ramelteon8 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female age 18-65 yrs.
- A diagnosis of seasonal affective disorder
- A Pittsburgh Sleep Quality Index >5
- English speaking
- Be able to sign informed consent
Key exclusion criteria (6 listed)
- Active substance abuse
- Current psychotic symptoms
- Severe personality disorders
- Primary sleep disorders
- Severe chronic obstructive pulmonary disease (COPD)
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 |
|---|---|---|
| RamelteonAlso: Rozeremone 8 mg tablet at bed for up to 4 months | Drug | Ramelteon |
| Placeboone tablet at bedtime for up to 4 months | Drug | Placebo |
Primary outcome
Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Monthly for duration of treatment (up to 4 months)
Self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Score ranges from 0-21, higher scores represent more significant sleep disturbance.
2 secondary outcomes
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)
Time frame: Monthly for duration of treatment (up to 4 months)
Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)
Time frame: Monthly for duration of treatment (up to 4 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11513820Avery DH, Eder DN, Bolte MA, Hellekson CJ, Dunner DL, Vitiello MV, Prinz PN. Dawn simulation and bright light in the treatment of SAD: a controlled study. Biol Psychiatry. 2001 Aug 1;50(3):205-16. doi: 10.1016/s0006-3223(01)01200-8.
- Background: PubMed 638392Biggs JT, Wylie LT, Ziegler VE. Validity of the Zung Self-rating Depression Scale. Br J Psychiatry. 1978 Apr;132:381-5. doi: 10.1192/bjp.132.4.381.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 1947597Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8.
- Background: PubMed 17683643Desan PH, Weinstein AJ, Michalak EE, Tam EM, Meesters Y, Ruiter MJ, Horn E, Telner J, Iskandar H, Boivin DB, Lam RW. A controlled trial of the Litebook light-emitting diode (LED) light therapy device for treatment of Seasonal Affective Disorder (SAD). BMC Psychiatry. 2007 Aug 7;7:38. doi: 10.1186/1471-244X-7-38.
- Background: PubMed 12957828Dubocovich ML, Rivera-Bermudez MA, Gerdin MJ, Masana MI. Molecular pharmacology, regulation and function of mammalian melatonin receptors. Front Biosci. 2003 Sep 1;8:d1093-108. doi: 10.2741/1089.
- Background: PubMed 7594173Gentili A, Weiner DK, Kuchibhatla M, Edinger JD. Test-retest reliability of the Pittsburgh sleep quality index in nursing home residents. J Am Geriatr Soc. 1995 Nov;43(11):1317-8. doi: 10.1111/j.1532-5415.1995.tb07415.x. No abstract available.
- Background: PubMed 15800134Golden RN, Gaynes BN, Ekstrom RD, Hamer RM, Jacobsen FM, Suppes T, Wisner KL, Nemeroff CB. The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence. Am J Psychiatry. 2005 Apr;162(4):656-62. doi: 10.1176/appi.ajp.162.4.656.
- BackgroundHellpach, W.H. (1911). Die geopsychischen erschelnungen; Wetter und klima und landschaft in ihrem einfluss auf das seelenleben. Leipzig: W. Engelmann.
- Background: PubMed 4617659Jenner FA. Chronobiology and the clinical psychiatrist: the current position. Chronobiologia. 1974 Apr-Jun;1(2):151-60. No abstract available.
- Background: PubMed 8526243Lam RW, Gorman CP, Michalon M, Steiner M, Levitt AJ, Corral MR, Watson GD, Morehouse RL, Tam W, Joffe RT. Multicenter, placebo-controlled study of fluoxetine in seasonal affective disorder. Am J Psychiatry. 1995 Dec;152(12):1765-70. doi: 10.1176/ajp.152.12.1765.
- Background: PubMed 12167524Levitt AJ, Lam RW, Levitan R. A comparison of open treatment of seasonal major and minor depression with light therapy. J Affect Disord. 2002 Sep;71(1-3):243-8. doi: 10.1016/s0165-0327(01)00397-4.
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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.
Edward R. Norris, MD principal investigator
Lehigh Valley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramelteon in people with Seasonal Affective Disorder, run by Lehigh Valley Hospital 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 6 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 6 Oct 2009. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) (time frame: Monthly for duration of treatment (up to 4 months)). 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 NCT00502320, which also lists 34 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 6 Oct 2009.