Bipolar DisorderNCT00229151
Sleep Deprivation and Advancement of Sleep Period as Treatment for Bipolar Depression.
A study testing Sleep deprivation and sleep phase advancement and usual treatment in people with Bipolar Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to determine if sleep deprivation and sleep phase advancement is effective treatment of bipolar patients in a depressive phase. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Sleep deprivation and sleep phase advancement and usual treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2005to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bipolar disorder, depressive phase
Who cannot join
- substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology, Institute of Neuroscience
Trondheim, 7489
About this study
Official title: Sleep Deprivation and Three Days Sleep Phase Advancement as Treatment for Bipolar Depression.
The purpose of this study is to determine if sleep deprivation and sleep phase advancement is effective treatment of bipolar patients in a depressive phase.
Read the detailed description
Background: The onset of therapeutic action for most anti-depressive treatments is usually two weeks. During this period patients suffer from great symptomatic distress. Treatment options that are effective in this period is therefore of interest for psychiatric wards.
Aim: To explore if sleep deprivation and three days sleep phase advancement is effective treatment for inpatients with bipolar disorder in a depressive phase.
Method: A randomized controlled trial with 24 patients diagnosed with bipolar disorder. Patients will be randomized to treatment as usual in an psychiatric ward, or sleep deprivation and three days sleep phase advancement. Patients in the treatment as usual group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria.
- Conditions
- Bipolar Disorder
- Being tested
- Sleep deprivation and sleep phase advancement, usual treatment
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivation and sleep phase advancementBehavioural
Total sleep deprivation from 0800 to 1700 next day, and three day sleep phase advancement following sleep deprivation.
usual treatmentOther
Treatment as usual in the psychiatric ward. Patients in this group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria
| Study group | Role | What they receive |
|---|---|---|
| Sleep deprivation | Experimental | Sleep deprivation and sleep phase advancement Receives: Behavioral: Sleep deprivation and sleep phase advancement |
| usual treatment | Active comparator | Not described Receives: Other: usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on rating scales for depression and symptom severity.
Measured: one month
Secondary outcomes (1)
Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: recruiting problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar Morken, PhD MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229151
- Sponsor's protocol ID
- S2005.1.depr
- Status last verified
- Apr 2012
- First submitted
- 27 Sep 2005
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Deprivation and Three Days Sleep Phase Advancement as Treatment for Bipolar Depression.
- ClinicalTrials.gov ID
- NCT00229151
- Acronym / sponsor ID
- S2005.1.depr
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruiting problems
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Sep 2005 (estimated)
- Results
- Not posted in the source record
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 if sleep deprivation and sleep phase advancement is effective treatment of bipolar patients in a depressive phase.
Detailed description
Background: The onset of therapeutic action for most anti-depressive treatments is usually two weeks. During this period patients suffer from great symptomatic distress. Treatment options that are effective in this period is therefore of interest for psychiatric wards.
Aim: To explore if sleep deprivation and three days sleep phase advancement is effective treatment for inpatients with bipolar disorder in a depressive phase.
Method: A randomized controlled trial with 24 patients diagnosed with bipolar disorder. Patients will be randomized to treatment as usual in an psychiatric ward, or sleep deprivation and three days sleep phase advancement. Patients in the treatment as usual group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep deprivation | Experimental | Behavioral: Sleep deprivation and sleep phase advancementSleep deprivation and sleep phase advancement |
| usual treatment | Active comparator | Other: usual treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bipolar disorder, depressive phase
Key exclusion criteria (1 listed)
- substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.
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 |
|---|---|---|
| Sleep deprivation and sleep phase advancementTotal sleep deprivation from 0800 to 1700 next day, and three day sleep phase advancement following sleep deprivation. | Behavioural | Sleep deprivation |
| usual treatmentTreatment as usual in the psychiatric ward. Patients in this group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria | Other | usual treatment |
Primary outcome
Scores on rating scales for depression and symptom severity.
Time frame: one month
1 secondary outcome
Scores on rating scales for anxiety, mania, cognitive processing, and sleep quality.
Time frame: one month
Results and safety
The study was stopped early (reason given: recruiting problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
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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.
Gunnar Morken, PhD MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep deprivation and sleep phase advancement and usual treatment in people with Bipolar Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 1 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 9 Apr 2012. 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 Norway. 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.
Are results available for this study?
The study was stopped early (reason given: recruiting problems). Results are not available in the source record.
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?
Scores on rating scales for depression and symptom severity. (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2012.