About this trial

Bipolar disorders (BD) are a group of complex disorders that impact mood, behaviour and cognition and are known to cause significant suffering and impairment. Circadian rhythm (your internal day/night "clock") disruption, which can involve changes in sleep-wake cycles, frequently occurs in BD. Both depression and mania are accompanied by circadian disruption. These disruptions are hypothesized to lead to mood worsening, metabolic dysfunction and inflammation. If circadian dysfunction plays a significant role in the symptoms and trajectory of BD, then treatment approaches that target these functions may lead to better outcomes. One such approach is dietary interventions. Time restricted eating (TRE) is a dietary tool that restricts the eating to an 8-12 hour window, without changing diet quality or caloric intake. Studies involving time restricted eating have been done in other conditions with promising results. There have been no studies done for mood disorders in general or bipolar disorder specifically. In this proposal, the investigators will assess two dietary interventions (TRE and nutritional counselling) to examine how TRE may represent a safe and viable adjunct to traditional treatments. The investigators aim to compare TRE with nutritional counselling, while all participants continue to receive usual care. Participants will receive support from a registered dietician and will be instructed on dietary habits. Half of participants will receive nutritional counselling and half will be asked to do TRE. Those in the TRE group will be asked to select a 10-hour window to consume all food and non-water beverages for the 8-week period. Participants will be asked to complete a screening visit to determine eligibility, and then will complete questionnaires at baseline, week 4 and week 8 examining symptoms of their illness and cognition. Participants will also provide a blood sample at baseline and week 8 for standard biochemistry tests, pregnancy testing (if applicable), and to examine inflammatory markers. Participants will also wear an actigraphy watch which provides wireless continuous monitoring of movements and ambient light. The primary outcome is feasibility and acceptability (do people agree to participate, complete the study, and follow the intervention; what do they think of the intervention). Secondary outcomes include changes in depression, anxiety, sleep, and cognition. Exploratory outcomes include inflammatory markers and circadian disruption.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be 18-55 years old

Have a diagnosis of bipolar I or bipolar II disorder, confirmed by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-5.

Have depression symptoms as indicated by a score of ≥12 on MADRS and ≤12 on YMRS.

Females of childbearing potential are willing to follow highly effective methods of contraception (mentioned below) for the duration of study*

Disqualifiers

Have any catatonic symptoms or eating disorder(s) as measured by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-5.

Have any unstable or inadequately treated neurological and medical conditions.

Have had prior bariatric surgery. 4 Be taking hypoglycemia inducing medications.

Trial design

Design model

Parallel

Treatments tested in this trial

Time restricted eating
Behavioral
Time restricted eating involves restricting the window in which calories are consumed to 8-10 hours, without altering diet quality or caloric intake. In this study, time restricted eating will be a consistent 10-h eating window between 06:00 and 19:00, considered an early TRE pattern, for all days of the week, as chosen by the participant. They will need to consume all food and beverages (except water) during this window for the duration of the 8-week intervention.
Eating ad libitum with nutritional counselling
Behavioral
Nutritional counselling will include customized advice delivered by a registered dietician about dietary choices while allowing individuals to eat at any time of day.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Group 1: Eating ad libitum, nutritional counselling plus treatment as usualOther 1 intervention

Group B: Group 2:Time-restricted eating plus treatment as usualOther 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants who complete the study

The investigators will consider the intervention feasible if 70% of participants complete follow-up.

Time frame

18 months

2

Time to recruit all participants

The investigators will consider the intervention feasible if 70% of participants complete follow-up.

Time frame

18 months

3

Intervention adherence

The investigators will consider the intervention acceptable if participant adherence to the intervention is at least 70% (i.e. participants adhere to the TRE intervention 40 days out of 56 days); ii) at least 50% of participants approached about the study agree to participate.

Time frame

18 months

4

Rate of participation

The investigators will consider the intervention acceptable if at least 50% of potential participants approached about the study agree to participate.

Time frame

18 months

Secondary outcomes

1

Depression severity - Montgomery-Åsberg Depression Rating Scale

The Montgomery-Åsberg Depression Rating Scale (Structured Interview Guide) (MADRS) is a 10-item observer-rated scale to assess the severity of depressive symptoms within the last 7 days. Possible total score range is 0-60. Score of: 0-8 indicates remission/absent symptoms; 9-17 mild depression, 18-34 moderate depression; and 35-60 severe depression.

Time frame

Screening, Baseline (week 1), Week 4, Week 8

2

Cognitive dysfunction - Cognitive Complaints in Bipolar Disorder Rating Assessment

A 16-item self-report that assess subjective cognitive dysfunction (including executive function, processing speed, working memory, verbal learning and memory, attention/concentration and mental tracking) in bipolar disorder. Measured on a 4-point Likert scale ranging from never (0) to always (3). Scores range 0-48 with higher scores indicating worse cognitive dysfunction.

Time frame

Baseline (week 1), Week 4, Week 8

3

Cognitive Dysfunction - Screen for Cognitive Impairment in Psychiatry

The Screen for Cognitive Impairment in Psychiatry (SCIP) is a brief clinician administered evaluation of cognitive deficits including working memory, immediate and delayed verbal list learning, verbal fluency, and psychomotor speed. Score is calculated as a sum of 5 subgroups, with subgroup 3 having no limit to the total score. Total score ranges from 0 with no upper limit, with lower scores showing more cognitive impairment. These scores are interpreted in the following manner: total score of \< 75 suggest mild impairment, score of \< 65 indicate moderate impairment, and score of \< 55 indicate severe impairment.

Time frame

Baseline (week 1), Week 4, Week 8

4

Anxiety severity - Hamilton Anxiety Rating Scale

The Hamilton Anxiety Rating Scale (HAM-A) is a 14-item semi-structured observer-rated interview evaluating symptoms of anxiety. Each item is scored 0 (not present) to - 4 (very severe). Scores range 0-56 with higher scoring indicating worse severity of anxiety symptoms. These scores are interpreted in the following manner: scores of 0-7 indicate remission/symptom absence, 8-14 mild anxiety, 15-23 moderate anxiety and 24-56 severe anxiety.

Time frame

Baseline (week 1), Week 4, Week 8

Other outcomes

1

Change in circadian rhythms

Using wrist actigraphy, the investigators will collect data on two 24-hour sleep-wake cycles. The validated wrist actigraphy monitor will collect non-invasive, wireless continuous monitoring of movements and ambient light (in the blue, green and red spectrum). These two measures will be combined to extract sleep estimates and parameters of the 24-hour activity-rest cycle before and after the intervention. Changes in the circadian rhythms (hours of sleep or movement) will be compared pre- and post between treatment groups.

Time frame

Week 0, Week 9

2

Change in C-reactive protein levels

The investigators will collect blood samples and measure levels of C-reactive protein (CRP) before and after the intervention. CRP is an inflammation marker and measured in mg/L.

Time frame

Baseline (week 1), Week 8

3

Change in cytokine levels

The investigators may collect blood samples and measure levels of cytokines including interleukins (IL) -6, IL-10, IL-1B and tumor necrosis factor alpha (TNF-a) before and after the intervention. IL-6, IL-10 and TNF-a are inflammatory cytokines and IL-10 is an anti-inflammation cytokine. All cytokines are measured in pg/mL.

Time frame

Baseline (week 1), Week 8

4

Change in red blood cell count

The investigators will collect blood samples to evaluate changes in red blood cell count (RBC) as part of changes in hematology before and after intervention. This will be done as part of a complete blood count (CBC) will be conducted to investigate changes in various blood components. RBC is measured in x10\*12/L

Time frame

Baseline (week 1), Week 8

SYNCED - SYNChronized Eating in Bipolar Depression Study

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts