- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05340686
Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression
Braining - A Randomized Controlled Study on Moderate-vigorous Aerobic Physical Exercise (PE) as an add-on Treatment in Bipolar Disorder. Effects on Recovery Time and Long-term Prevention From Bipolar Depression
Study Overview
Status
Conditions
Detailed Description
The hypothesis of this study is that adding aerobic PE might accelerate recovery, reduce negative side effects, improve mental wellbeing and function, increase long term prevention against relapsing bipolar episodes and reduce risk for complications such as cardiovascular disease in patients with bipolar disorder. Furthermore the study aims to evaluate if the effect of PE is linked to biological factors such as genetical factors, stress hormone levels, level of inflammation and other biological markers for health and disease that can be measured in standard blood samples.
Patients diagnosed with bipolar disorder with ongoing depression are invited to participate in the study at regular visits in the psychiatric clinic. All study participants are medicated with mood stabilizers according to routine treatment and receive regular treatment for bipolar depression. After informed consent the study participants will be randomized to one of three groups 1) moderate to vigorous PE group training together with psychiatric staff three times per week 2) relaxing and stretching exercises group training together with psychiatric staff three times per week 3) information about PE and relaxation but no supervised PE or relaxation/stretching, for the 6 weeks of the study period.
BEFORE: The first week consists of pre-test including interview regarding medical history and physical and psychiatric examination, ECG and blood samples. To measure level of physical activity the participants wear an activity monitor, Actiheart, that continuously registers physical activity for 7 days. The study participants will also fill out different questionnaires regarding general health and psychiatric symptoms.
STUDY PERIOD: During the 6 weeks long study period the participants fill out an activity questionnaire and health questionnaires once a week.
AFTER: during the sixth week of the study period evaluation is being performed with repetition of the physical and psychiatric examination, blood samples and questionnaires. After 1, 2 and 3 years after the exercise period the questionnaires are repeated. Blood samples are repeated one year after the study period.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Åsa Anger, MD
- Phone Number: +46858580445
- Email: asa.susanna.anger@ki.se
Study Locations
-
-
-
Stockholm, Sweden, 14186
- Recruiting
- Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
-
Principal Investigator:
- Lina Martinsson, PhD
-
Contact:
- Åsa Anger, MD
- Email: asa.susanna.anger@ki.se
-
Contact:
- Anna Wallerblad, MD
- Email: anna.wallerblad@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients at Psychiatry Southwest, Karolinska University Hospital Region Stockholm Sweden.
- Bipolar disorder
- Ongoing depression, defined as a PHQ-9 score of 9 or higher at any occasion 2 weeks before inclusion.
Exclusion Criteria:
- Severe psychiatric disorder such as mania and psychosis
- Medical conditions such as heart- and lung diseases where PE is contraindicated.
- Unable to understand written and spoken Swedish language.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Braining high intensity
Moderate to vigorous physical exercise, supervised by psychiatric staff 3 times per week
|
Moderate to vigorous physical exercise 30-45 minutes in a group setting led by psychiatric staff, 3 times per week for 6 weeks
|
Active Comparator: Braining relaxing exercise
Relaxation, light yoga or stretching exercise, supervised by psychiatric staff 3 times per week
|
Relaxing exercises (stretching, light yoga) 30-45 minutes in a group setting led by psychiatric staff, 3 times per week for 6 weeks
|
Active Comparator: Information about physical exercise
Written and oral information about health benefits from physical exercise, provided by researcher on one occasion.
|
Written and oral information about physical exercise recommendations, on one occasion, by researcher
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PHQ-9 (Patient Health Questionnaire - 9 items)
Time Frame: At follow up 12 months after intervention.
|
Self rated depressive symptoms.
Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
|
At follow up 12 months after intervention.
|
PHQ-9 (Patient Health Questionnaire - 9 items)
Time Frame: At follow up 24 months after intervention.
|
Self rated depressive symptoms.
Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
|
At follow up 24 months after intervention.
|
PHQ-9 (Patient Health Questionnaire - 9 items)
Time Frame: At follow up 36 months after intervention.
|
Self rated depressive symptoms.
Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
|
At follow up 36 months after intervention.
|
PHQ-9 (Patient Health Questionnaire - 9 items)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Self rated depressive symptoms.
Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
|
Change from inclusion to follow up 6 weeks after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AS-18 (Affective self rating scale)
Time Frame: At follow up 12 months after intervention.
|
Self-assessment of symptoms of depression and hypomania/mania.
9 items for depression and 9 items for mania.
Score 0-72.
A score of over 10 on the depressive or manic/hypomanic subscale should give rise to suspicion of ongoing depression and hypomania/mania respectively.
Scores of over 10 on both the depressive and manic/hypomanic scale at the same time give may indicate an affective mixed state.
|
At follow up 12 months after intervention.
|
AS-18 (Affective self rating scale)
Time Frame: At follow up 24 months after intervention.
|
Self-assessment of symptoms of depression and hypomania/mania.
9 items for depression and 9 items for mania.
Score 0-72.
A score of over 10 on the depressive or manic/hypomanic subscale should give rise to suspicion of ongoing depression and hypomania/mania respectively.
Scores of over 10 on both the depressive and manic/hypomanic scale at the same time give may indicate an affective mixed state.
|
At follow up 24 months after intervention.
|
AS-18 (Affective self rating scale)
Time Frame: At follow up 36 months after intervention.
|
Self-assessment of symptoms of depression and hypomania/mania.
9 items for depression and 9 items for mania.
Score 0-72.
A score of over 10 on the depressive or manic/hypomanic subscale should give rise to suspicion of ongoing depression and hypomania/mania respectively.
Scores of over 10 on both the depressive and manic/hypomanic scale at the same time give may indicate an affective mixed state.
|
At follow up 36 months after intervention.
|
YMRS (Young Ziegler Mania Rating Scale)
Time Frame: At follow up 12 months after intervention.
|
Interviewer-rated scale.
Includes 11 items; seven are rated from 0 (absent) to 4; four from 0 to 8; total scores range from 0 to 60.
A higher value indicates worse symptoms of hypomania/mania.
|
At follow up 12 months after intervention.
|
YMRS (Young Ziegler Mania Rating Scale)
Time Frame: At follow up 24 months after intervention.
|
Interviewer-rated scale.
Includes 11 items; seven are rated from 0 (absent) to 4; four from 0 to 8; total scores range from 0 to 60.
A higher value indicates worse symptoms of hypomania/mania.
|
At follow up 24 months after intervention.
|
YMRS (Young Ziegler Mania Rating Scale)
Time Frame: At follow up 36 months after intervention.
|
Interviewer-rated scale.
Includes 11 items; seven are rated from 0 (absent) to 4; four from 0 to 8; total scores range from 0 to 60.
A higher value indicates worse symptoms of hypomania/mania.
|
At follow up 36 months after intervention.
|
CGI-S (Clinical Global Impressions - Severity Scale)
Time Frame: At follow up 12 months after intervention
|
A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
|
At follow up 12 months after intervention
|
CGI-S (Clinical Global Impressions - Severity Scale)
Time Frame: At follow up 24 months after intervention
|
A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
|
At follow up 24 months after intervention
|
CGI-S (Clinical Global Impressions - Severity Scale)
Time Frame: At follow up 36 months after intervention
|
A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
|
At follow up 36 months after intervention
|
Blood pressure
Time Frame: At follow up 12 months after intervention
|
systolic and diastolic, mmHg
|
At follow up 12 months after intervention
|
Blood pressure
Time Frame: At follow up 24 months after intervention
|
systolic and diastolic, mmHg
|
At follow up 24 months after intervention
|
Blood pressure
Time Frame: At follow up 36 months after intervention
|
systolic and diastolic, mmHg
|
At follow up 36 months after intervention
|
Heart rate
Time Frame: At follow up 12 months after intervention
|
Heart rate, beats per minute
|
At follow up 12 months after intervention
|
Heart rate
Time Frame: At follow up 24 months after intervention
|
Heart rate, beats per minute
|
At follow up 24 months after intervention
|
Heart rate
Time Frame: At follow up 36 months after intervention
|
Heart rate, beats per minute
|
At follow up 36 months after intervention
|
BMI (Body mass index)
Time Frame: At follow up 12 months after intervention
|
Weight in kg divided by the square of height in m
|
At follow up 12 months after intervention
|
BMI (Body mass index)
Time Frame: At follow up 24 months after intervention
|
Weight in kg divided by the square of height in m
|
At follow up 24 months after intervention
|
BMI (Body mass index)
Time Frame: At follow up 36 months after intervention
|
Weight in kg divided by the square of height in m
|
At follow up 36 months after intervention
|
Waist circumference
Time Frame: At follow up 12 months after intervention
|
Waist circumference, cm
|
At follow up 12 months after intervention
|
Waist circumference
Time Frame: At follow up 24 months after intervention
|
Waist circumference, cm
|
At follow up 24 months after intervention
|
Waist circumference
Time Frame: At follow up 36 months after intervention
|
Waist circumference, cm
|
At follow up 36 months after intervention
|
FBS (fasting blood sugar)
Time Frame: At follow up 12 months after intervention.
|
fasting blood sugar, mmol/l
|
At follow up 12 months after intervention.
|
FBS (fasting blood sugar)
Time Frame: At follow up 24 months after intervention.
|
fasting blood sugar, mmol/l
|
At follow up 24 months after intervention.
|
FBS (fasting blood sugar)
Time Frame: At follow up 36 months after intervention.
|
fasting blood sugar, mmol/l
|
At follow up 36 months after intervention.
|
HbA1c (Hemoglobin A1c)
Time Frame: At follow up 12 months after intervention.
|
Glycated hemoglobin, mmol/mol
|
At follow up 12 months after intervention.
|
HbA1c (Hemoglobin A1c)
Time Frame: At follow up 24 months after intervention.
|
Glycated hemoglobin, mmol/mol
|
At follow up 24 months after intervention.
|
HbA1c (Hemoglobin A1c)
Time Frame: At follow up 36 months after intervention.
|
Glycated hemoglobin, mmol/mol
|
At follow up 36 months after intervention.
|
Blood lipids
Time Frame: At follow up 12 months after intervention.
|
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
|
At follow up 12 months after intervention.
|
Blood lipids
Time Frame: At follow up 24 months after intervention.
|
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
|
At follow up 24 months after intervention.
|
Blood lipids
Time Frame: At follow up 36 months after intervention.
|
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
|
At follow up 36 months after intervention.
|
CRP (C-reactive protein)
Time Frame: At follow up 12 months after intervention.
|
Measurement of inflammation and infection, mmol/L
|
At follow up 12 months after intervention.
|
CRP (C-reactive protein)
Time Frame: At follow up 24 months after intervention.
|
Measurement of inflammation and infection, mmol/L
|
At follow up 24 months after intervention.
|
CRP (C-reactive protein)
Time Frame: At follow up 36 months after intervention.
|
Measurement of inflammation and infection, mmol/L
|
At follow up 36 months after intervention.
|
Telomere length
Time Frame: At follow up 12 months after intervention.
|
telomere length in leukocytes
|
At follow up 12 months after intervention.
|
Telomerase
Time Frame: At follow up 12 months after intervention.
|
Enzyme activity in blood
|
At follow up 12 months after intervention.
|
WHODAS 2.0 (World health organization disability assessment schedule)
Time Frame: At follow up 12 months after intervention.
|
Self rated disability.
Minimum value 0, maximum value 100, where higher values indicate more disability.
|
At follow up 12 months after intervention.
|
WHODAS 2.0 (World health organization disability assessment schedule)
Time Frame: At follow up 24 months after intervention.
|
Self rated disability.
Minimum value 0, maximum value 100, where higher values indicate more disability.
|
At follow up 24 months after intervention.
|
WHODAS 2.0 (World health organization disability assessment schedule)
Time Frame: At follow up 36 months after intervention.
|
Self rated disability.
Minimum value 0, maximum value 100, where higher values indicate more disability.
|
At follow up 36 months after intervention.
|
EQ-5D-5L (EuroQol VAS)
Time Frame: At follow up 12 months after intervention.
|
Self-assessment instrument for describing and valuing health.
Defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.
Also included is an overall health rating on a 0-100 hash-marked, vertical visual analogue scale (EQ-VAS).
Assessment the scores from the descriptive component can be reported as a five digit number ranging from 11111 (full health) to 55555 (worst health).
A number of methods exist for analysing these five digit profiles.
However, frequently they are converted to a single utility index using country specific value sets.
A higher index number indicates a poorer self-assessed health.
|
At follow up 12 months after intervention.
|
EQ-5D-5L (EuroQol VAS)
Time Frame: At follow up 24 months after intervention.
|
Self-assessment instrument for describing and valuing health.
Defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.
Also included is an overall health rating on a 0-100 hash-marked, vertical visual analogue scale (EQ-VAS).
Assessment the scores from the descriptive component can be reported as a five digit number ranging from 11111 (full health) to 55555 (worst health).
A number of methods exist for analysing these five digit profiles.
However, frequently they are converted to a single utility index using country specific value sets.
A higher index number indicates a poorer self-assessed health.
|
At follow up 24 months after intervention.
|
EQ-5D-5L (EuroQol VAS)
Time Frame: At follow up 36 months after intervention.
|
Self-assessment instrument for describing and valuing health.
Defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.
Also included is an overall health rating on a 0-100 hash-marked, vertical visual analogue scale (EQ-VAS).
Assessment the scores from the descriptive component can be reported as a five digit number ranging from 11111 (full health) to 55555 (worst health).
A number of methods exist for analysing these five digit profiles.
However, frequently they are converted to a single utility index using country specific value sets.
A higher index number indicates a poorer self-assessed health.
|
At follow up 36 months after intervention.
|
SRH (Self-rated health)
Time Frame: At follow up 12 months after intervention.
|
SRH is typically measured as a single-item, the most common wording of which is "In general, would you say your health is" with the response items "excellent," "very good," "good," "fair," or "poor."
|
At follow up 12 months after intervention.
|
SRH (Self-rated health)
Time Frame: At follow up 24 months after intervention.
|
SRH is typically measured as a single-item, the most common wording of which is "In general, would you say your health is" with the response items "excellent," "very good," "good," "fair," or "poor."
|
At follow up 24 months after intervention.
|
SRH (Self-rated health)
Time Frame: At follow up 36 months after intervention.
|
SRH is typically measured as a single-item, the most common wording of which is "In general, would you say your health is" with the response items "excellent," "very good," "good," "fair," or "poor."
|
At follow up 36 months after intervention.
|
BBQ (Brunnsviken Brief Quality of Life Questionnaire)
Time Frame: At follow up 12 months after intervention.
|
Self rated quality of life.
Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
|
At follow up 12 months after intervention.
|
BBQ (Brunnsviken Brief Quality of Life Questionnaire)
Time Frame: At follow up 24 months after intervention.
|
Self rated quality of life.
Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
|
At follow up 24 months after intervention.
|
BBQ (Brunnsviken Brief Quality of Life Questionnaire)
Time Frame: At follow up 36 months after intervention.
|
Self rated quality of life.
Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
|
At follow up 36 months after intervention.
|
Occupational level measured in % of work ability in medical certificate
Time Frame: At follow up 12 months after intervention.
|
Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%.
|
At follow up 12 months after intervention.
|
Occupational level measured in % of work ability in medical certificate
Time Frame: At follow up 24 months after intervention.
|
Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%.
|
At follow up 24 months after intervention.
|
Occupational level measured in % of work ability in medical certificate
Time Frame: At follow up 36 months after intervention.
|
Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%.
|
At follow up 36 months after intervention.
|
MADRS (Montgomery-Åsberg Depression Rating Scale)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Clinician-rated scale to assess degree of depressive symptoms.
10 items.
Minimum value 0 and maximum value 60, where higher values indicate more depressive symptoms.
|
Change from inclusion to follow up 6 weeks after inclusion
|
AS-18 (Affective self rating scale)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Self-assessment of symptoms of depression and hypomania/mania.
9 items for depression and 9 items for mania.
Score 0-72.
A score of over 10 on the depressive or manic/hypomanic subscale should give rise to suspicion of ongoing depression and hypomania/mania respectively.
Scores of over 10 on both the depressive and manic/hypomanic scale at the same time give may indicate an affective mixed state.
|
Change from inclusion to follow up 6 weeks after inclusion
|
YMRS (Young Ziegler Mania Rating Scale)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Interviewer-rated scale.
Includes 11 items; seven are rated from 0 (absent) to 4; four from 0 to 8; total scores range from 0 to 60.
A higher value indicates worse symptoms of hypomania/mania.
|
Change from inclusion to follow up 6 weeks after inclusion
|
CGI-S (Clinical Global Impressions - Severity Scale)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
|
Change from inclusion to follow up 6 weeks after inclusion
|
Blood pressure
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
systolic and diastolic, mmHg
|
Change from inclusion to follow up 6 weeks after inclusion
|
Heart rate
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Heart rate, beats per minute
|
Change from inclusion to follow up 6 weeks after inclusion
|
BMI (Body mass index)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Weight in kg divided by the square of height in m
|
Change from inclusion to follow up 6 weeks after inclusion
|
Waist circumference
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Waist circumference, cm
|
Change from inclusion to follow up 6 weeks after inclusion
|
FBS (fasting blood sugar)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
fasting blood sugar, mmol/l
|
Change from inclusion to follow up 6 weeks after inclusion
|
HbA1c (Hemoglobin A1c)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Glycated hemoglobin, mmol/mol
|
Change from inclusion to follow up 6 weeks after inclusion
|
Blood lipids
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
|
Change from inclusion to follow up 6 weeks after inclusion
|
CRP (C-reactive protein)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Measurement of inflammation and infection, mmol/L
|
Change from inclusion to follow up 6 weeks after inclusion
|
Telomere length
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
telomere length in leukocytes
|
Change from inclusion to follow up 6 weeks after inclusion
|
Telomerase
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Enzyme activity in blood
|
Change from inclusion to follow up 6 weeks after inclusion
|
WHODAS 2.0 (World health organization disability assessment schedule)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Self rated disability.
Minimum value 0, maximum value 100, where higher values indicate more disability.
|
Change from inclusion to follow up 6 weeks after inclusion
|
EQ-5D-5L (EuroQol VAS)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Self-assessment instrument for describing and valuing health.
Defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.
Also included is an overall health rating on a 0-100 hash-marked, vertical visual analogue scale (EQ-VAS).
Assessment the scores from the descriptive component can be reported as a five digit number ranging from 11111 (full health) to 55555 (worst health).
A number of methods exist for analysing these five digit profiles.
However, frequently they are converted to a single utility index using country specific value sets.
A higher index number indicates a poorer self-assessed health.
|
Change from inclusion to follow up 6 weeks after inclusion
|
SRH (Self-rated health)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
SRH is typically measured as a single-item, the most common wording of which is "In general, would you say your health is" with the response items "excellent," "very good," "good," "fair," or "poor."
|
Change from inclusion to follow up 6 weeks after inclusion
|
BBQ (Brunnsviken Brief Quality of Life Questionnaire)
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Self rated quality of life.
Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
|
Change from inclusion to follow up 6 weeks after inclusion
|
Occupational level measured in % of work ability in medical certificate
Time Frame: Change from inclusion to follow up 6 weeks after inclusion
|
Complete sick leave 0%, partial sick leave 25-75 %, completely able to work 100%.
|
Change from inclusion to follow up 6 weeks after inclusion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lina Martinsson, PhD, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Braining Bipolar RCT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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