Major Depressive DisorderGZPHBLTNCT04447430
Light Therapy to Improve Symptoms in Pregnant Women With Major Depressive Disorder
A study testing bright light and dim red light in people with Major Depressive Disorder, run by Guangzhou Psychiatric Hospital at 1 site in China.
Trial summary
This study will investigate the effectivenss of bright light therapy(10000 lux white)on pregnant women with major depression disorder. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- bright light and dim red light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2020to 30 Dec 2021
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women; 18~45 years of age; medically healthy, with normal ocular function; 13~28 weeks pregnancy; DSM-V diagnosis of major depressive disorder HAMD score ≥18
Who cannot join
- DSM-V defined bipolar disorder、schizophrenia、schizoaffective disorder,anxiety disorders; substance Use Disorders; substance use within the last 6 months; suicidal ideation, suicidal attempt, suicide behavior, and attempted suicide; being treated by the light therapy; with antidepressant in recent 2 months; Multiple pregnancy; Any obstetrical care or medications for physical disorders that might confound treatment results; current use of β-adrenergic blockers, melatonin, or St. John's wort; thyroid function test results inconsistent with normal pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
Guanzhou, Guangdong, 510370
Kangguang Lin, MD，PhD, 13560360144, klin@connect.hku.hk
About this study
Official title: Bright Light Therapy in Pregnant Women With Major Depressive Disorder: a Randomized, Double-blind, Placebo-Controlled Study
This study will investigate the effectivenss of bright light therapy(10000 lux white)on pregnant women with major depression disorder.
Read the detailed description
Depression during pregnancy is a common and high impact disease.Children who are exposed to maternal depression during pregnancy have a higher risk of adverse birth outcomes, such as low birth weight, and more often show cognitive, emotional and behavioral problems.Therefore, early detection and prompt treatment of depression during pregnancy can benefit both mother and child.However, the window of opportunity in pregnancy is small and from the perspective of the child postponement is in fact non-treatment. Psychotherapy might take a long time to be effective and do not work for all people. Further, the safety of pharmacological treatment for pregnant women with depression is still a big concern .Psychiatric medication use for depression in pregnancy may also pose a risk of fetal growth retardation and preterm delivery, as well as withdrawal symptoms in the new born. Therefore, investigating non-pharmacological approaches to treating depression during pregnancy is urgent and relevant, for both mother and child. Preliminary evidence shows that bright light therapy (BLT) is an effective treatment for pregnant women with depression based on several theoretical and clinical considerations, with effect size around 0.45 and without adverse effects to the new born. In this study we aim to investigate the effectiveness of BLT on pregnant women with major depression.
- Conditions
- Major Depressive Disorder
- Being tested
- bright light, dim red light
- Keywords
- Light therapy; Major Depressive Disorder; Pregnancy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bright lightDevice
treat patients with bright light, 30 min per day, 7 times per week, over 6 weeks
dim red lightDevice
treat patients with dim red light, 30 min per day, 7 times per week, over 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| bright light group | Experimental | treat patients with bright light (10000 lux) Receives: Device: bright light |
| dim red light group | Placebo comparator | treat patients with dim red light (100 lux) Receives: Device: dim red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depressive symptoms from baseline
Depressive symptoms will be measured by Hamilton Depression Rating Scale (HAMD)
Measured: Week2;Week6
Secondary outcomes (1)
Changes in anxious symptoms from baseline
anxious symptoms will be measured by the Hamilton Anxiety Scale(HAMA)
Measured: week 2; week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start12 Jun 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Psychiatric Hospital
- Sponsor type
- Other government
- Collaborators
- The Third Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Kangguang Lin, Guangzhou Psychiatric Hospital
- Investigators
- Kangguang Lin, MD,PhD, Principal investigator, Guangzhou Brain Hospital(Guangzhou Psychiatric Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447430
- Sponsor's protocol ID
- GuangzhouPHBLT
- Acronym
- GZPHBLT
- Status last verified
- Jun 2020
- First submitted
- 23 Jun 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Therapy in Pregnant Women With Major Depressive Disorder: a Randomized, Double-blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT04447430
- Acronym / sponsor ID
- GZPHBLT / GuangzhouPHBLT
- Conditions
- Major Depressive Disorder
- Keywords
- Light therapy; Major Depressive Disorder; Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Guangzhou Psychiatric HospitalOther government
- Collaborators
- The Third Affiliated Hospital of Guangzhou Medical University
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 25 Jun 2020 (actual)
- 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.
This study will investigate the effectivenss of bright light therapy(10000 lux white)on pregnant women with major depression disorder.
Detailed description
Depression during pregnancy is a common and high impact disease.Children who are exposed to maternal depression during pregnancy have a higher risk of adverse birth outcomes, such as low birth weight, and more often show cognitive, emotional and behavioral problems.Therefore, early detection and prompt treatment of depression during pregnancy can benefit both mother and child.However, the window of opportunity in pregnancy is small and from the perspective of the child postponement is in fact non-treatment. Psychotherapy might take a long time to be effective and do not work for all people. Further, the safety of pharmacological treatment for pregnant women with depression is still a big concern .Psychiatric medication use for depression in pregnancy may also pose a risk of fetal growth retardation and preterm delivery, as well as withdrawal symptoms in the new born. Therefore, investigating non-pharmacological approaches to treating depression during pregnancy is urgent and relevant, for both mother and child. Preliminary evidence shows that bright light therapy (BLT) is an effective treatment for pregnant women with depression based on several theoretical and clinical considerations, with effect size around 0.45 and without adverse effects to the new born. In this study we aim to investigate the effectiveness of BLT on pregnant women with major depression.
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 |
|---|---|---|
| bright light group | Experimental | Device: bright lighttreat patients with bright light (10000 lux) |
| dim red light group | Placebo comparator | Device: dim red lighttreat patients with dim red light (100 lux) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women; 18~45 years of age; medically healthy, with normal ocular function; 13~28 weeks pregnancy; DSM-V diagnosis of major depressive disorder HAMD score ≥18
Key exclusion criteria (1 listed)
- DSM-V defined bipolar disorder、schizophrenia、schizoaffective disorder,anxiety disorders; substance Use Disorders; substance use within the last 6 months; suicidal ideation, suicidal attempt, suicide behavior, and attempted suicide; being treated by the light therapy; with antidepressant in recent 2 months; Multiple pregnancy; Any obstetrical care or medications for physical disorders that might confound treatment results; current use of β-adrenergic blockers, melatonin, or St. John's wort; thyroid function test results inconsistent with normal pregnancy
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 |
|---|---|---|
| bright lighttreat patients with bright light, 30 min per day, 7 times per week, over 6 weeks | Device | bright light group |
| dim red lighttreat patients with dim red light, 30 min per day, 7 times per week, over 6 weeks | Device | dim red light group |
Primary outcome
Changes in depressive symptoms from baseline
Time frame: Week2;Week6
Depressive symptoms will be measured by Hamilton Depression Rating Scale (HAMD)
1 secondary outcome
Changes in anxious symptoms from baseline
Time frame: week 2; week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- 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.
Kangguang Lin, MD,PhD principal investigator
Guangzhou Brain Hospital(Guangzhou Psychiatric Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bright light and dim red light in people with Major Depressive Disorder, run by Guangzhou Psychiatric Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 25 Jun 2020. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kangguang Lin, MD,PhD (13560360144 ext. 18028619981, klin@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in depressive symptoms from baseline (time frame: Week2;Week6). 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 25 Jun 2020.