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SAM-SAD: Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder

Sponsor
Lehigh Valley Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00502320
Collaborator
Takeda Pharmaceuticals North America, Inc. (Industry)
50
Enrollment
1
Location
2
Arms
22
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether treating sleep difficulties in patients with seasonal affective disorder also improves their depressive symptoms.

Condition or Disease Intervention/Treatment Phase
Phase 4

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

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Randomized Placebo-Controlled Trial of Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder
Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ramelteon

8 mg

Drug: Ramelteon
one 8 mg tablet at bed for up to 4 months
Other Names:
  • Rozerem

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    one tablet at bedtime for up to 4 months

    Outcome Measures

    Primary Outcome Measures

    1. Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) [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.

    Secondary Outcome Measures

    1. Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS) [Monthly for duration of treatment (up to 4 months)]

      Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression.

    2. Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD) [Monthly for duration of treatment (up to 4 months)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • Active substance abuse

    • Current psychotic symptoms

    • Severe personality disorders

    • Primary sleep disorders

    • Severe chronic obstructive pulmonary disease (COPD)

    • Prescription fluvoxamine(Luvox) use

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lehigh Valley Hospital, Department of Psychiatry Allentown Pennsylvania United States 18103

    Sponsors and Collaborators

    • Lehigh Valley Hospital
    • Takeda Pharmaceuticals North America, Inc.

    Investigators

    • Principal Investigator: Edward R. Norris, MD, Lehigh Valley Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00502320
    Other Study ID Numbers:
    • 06-006R
    First Posted:
    Jul 17, 2007
    Last Update Posted:
    Oct 6, 2009
    Last Verified:
    Oct 1, 2009
    Keywords provided by , ,
    Seasonal Affective Disorder
    Ramelteon
    Psychiatry
    Randomized Controlled Trial
    Hamilton Depression Rating Scale- SAD Version
    Circadian Rhythm
    Additional relevant MeSH terms:
    Disease
    Mood Disorders
    Seasonal Affective Disorder

    Study Results

    Participant Flow

    Recruitment Details Recruitment began in August 2006 and was completed by October 2007. Participants, who at the time were receiving outpatient psychiatric services through Lehigh Valley Hospital, were recruited via referral through the department of psychiatry, and also through print advertisement. Participants received no compensation for participating in the study.
    Pre-assignment Detail 50 individuals signed the informed consent document, one was a screen failure, so 49 participants started study medication. During the study, both treatment groups were maintained on their usual medications for depression and allowed treatment as usual, including medication adjustments.
    Arm/Group Title Ramelteon Placebo
    Arm/Group Description 8 mg pill taken by mouth nightly inactive sugar pill taken by mouth nightly
    Period Title: Overall Study
    STARTED 25 25
    Screening Visit 25 24
    COMPLETED 19 18
    NOT COMPLETED 6 7

    Baseline Characteristics

    Arm/Group Title Ramelteon Placebo Total
    Arm/Group Description 8 mg pill taken by mouth nightly inactive sugar pill taken by mouth nightly Total of all reporting groups
    Overall Participants 25 25 50
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    25
    100%
    25
    100%
    50
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    45.49
    (11.81)
    47.76
    (10.23)
    46.08
    (11.04)
    Sex: Female, Male (Count of Participants)
    Female
    19
    76%
    18
    72%
    37
    74%
    Male
    6
    24%
    7
    28%
    13
    26%
    Region of Enrollment (participants) [Number]
    United States
    25
    100%
    25
    100%
    50
    100%

    Outcome Measures

    1. Primary Outcome
    Title Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)
    Description 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.
    Time Frame Monthly for duration of treatment (up to 4 months)

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat analysis; excludes one screen failure.
    Arm/Group Title Ramelteon Placebo
    Arm/Group Description 8 mg pill taken by mouth nightly inactive sugar pill taken by mouth nightly
    Measure Participants 25 24
    Baseline
    11.56
    (0.75)
    11.45
    (0.77)
    Month 1
    9.52
    (0.84)
    8.67
    (0.90)
    Month 2
    7.57
    (0.84)
    8.62
    (0.89)
    Month 3
    8.07
    (0.83)
    9.88
    (0.85)
    Month 4
    7.05
    (0.85)
    9.61
    (0.87)
    2. Secondary Outcome
    Title Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)
    Description Self-rated scale to measure severity of depressive symptoms. Score ranges from 25-100, higher scores reflect more depression.
    Time Frame Monthly for duration of treatment (up to 4 months)

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat analysis; excludes one screen failure.
    Arm/Group Title Ramelteon Placebo
    Arm/Group Description 8 mg pill taken by mouth nightly inactive sugar pill taken by mouth nightly
    Measure Participants 25 24
    Baseline
    63.06
    (1.92)
    58.63
    (1.96)
    Month 1
    54.35
    (2.70)
    56.40
    (2.86)
    Month 2
    53.51
    (2.71)
    58.59
    (2.80)
    Month 3
    49.26
    (2.81)
    58.62
    (2.89)
    Month 4
    46.14
    (2.65)
    61.65
    (2.74)
    3. Secondary Outcome
    Title Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)
    Description 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.
    Time Frame Monthly for duration of treatment (up to 4 months)

    Outcome Measure Data

    Analysis Population Description
    Intention to Treat analysis; excludes one screen failure.
    Arm/Group Title Ramelteon Placebo
    Arm/Group Description 8 mg pill taken by mouth nightly inactive sugar pill taken by mouth nightly
    Measure Participants 25 24
    Baseline
    22.68
    (1.60)
    19.99
    (1.63)
    Month 1
    16.16
    (1.88)
    15.97
    (2.04)
    Month 2
    14.81
    (1.90)
    19.47
    (1.96)
    Month 3
    11.69
    (1.66)
    20.65
    (1.67)
    Month 4
    9.15
    (1.67)
    23.68
    (1.71)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Ramelteon Placebo
    Arm/Group Description 8 mg pill taken by mouth nightly inactive sugar pill taken by mouth nightly
    All Cause Mortality
    Ramelteon Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Ramelteon Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/ (NaN) 0/ (NaN)
    Psychiatric disorders
    Worsening depression leading to hospitalization 1/25 (4%) 1 0/24 (0%) 0
    Other (Not Including Serious) Adverse Events
    Ramelteon Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/ (NaN) 5/ (NaN)
    General disorders
    Fatigue 1/25 (4%) 1 1/24 (4.2%) 1
    Insomnia Exacerbation 1/25 (4%) 1 3/24 (12.5%) 3
    Nightmares 1/25 (4%) 1 0/24 (0%) 0
    Psychiatric disorders
    Anxiety 1/25 (4%) 1 0/24 (0%) 0
    Depression 1/25 (4%) 1 1/24 (4.2%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Edward R. Norris, MD
    Organization Lehigh Valley Hospital
    Phone 610-402-5766
    Email Edward.Norris@lvh.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00502320
    Other Study ID Numbers:
    • 06-006R
    First Posted:
    Jul 17, 2007
    Last Update Posted:
    Oct 6, 2009
    Last Verified:
    Oct 1, 2009