Micronutrients as Adjunctive Treatment for Bipolar Disorder

Scores on the Positive and Negative Symptom Scale (PANSS): The PANSS is a medical scale used to measure symptom severity of patients with schizophrenia. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale. Each of the 30 items is accompanied by a specific definition as well as detailed anchoring criteria for all seven rating points. These seven points represent increasing levels of psychopathology and range from 1 (absent) to 7 (extreme). The scores for these scales are arrived at by summation of ratings across component items. A Composite Scale is scored by subtracting the negative score from the positive score. This yields a bipolar index that ranges from -42 to +42, which is a difference score reflecting the degree of predominance of one syndrome in relation to the other.

Scores on the Young Mania Rating Scale (YMRS): The YMRS consists of 11 items. Items 5, 6, 8, and 9 are rated on a scale from 0 (symptoms not present) to 8 (symptoms extremely severe). The remaining items are rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe). Items 5, 6, 8, and 9 (irritability, speech, content and disruptive-aggressive behavior) are given twice the weight of the remaining seven in order to compensate for the poor condition of severely ill subjects.

Scores on the Hamilton Anxiety Scale (Ham-A): The Ham-A is a widely used interview measure designed to assess anxiety (Hamilton, 1969). It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). The Ham-A features both psychic and somatic anxiety subscales. The psychic subscale, which is comprised of items that address the more subjective cognitive and affective components of anxious experience (e.g., anxious mood, tension, fears, difficulty concentrating), is particularly useful in assessing the severity of anxiety. In contrast, the somatic subscale emphasizes features of anxiety that are somewhat less typical, including autonomic arousal, respiratory and cardiovascular symptoms.

Scores on the Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS (Montgomery \& Asberg, 1979), one of the most frequently used and validated observer-rated depression scales, is a 10-item rating scale to assess the severity of depressive symptoms within the last 7 days. The 10 selected items are rated on a scale of 0-6 with anchors at 2-point intervals. The interviewer is encouraged to use his or her observations of the patient's mental status as an additional source of information.

Scores on the My Medical Outcome Profile version 2 (MYMOP-2): The Health Services Research Collaboration of the UK's Medical Research Council has put together an individualized self-report measure called the MYMOP (Measure Yourself Medical Outcome Profile). The patient selects 2 symptoms to monitor --- things that matter to him/her. They also monitor 2 other things: an activity, and general sense of wellbeing. Medications are monitored as well.

The quality of life between groups will be assessed.

Scores on the Mini Nutritional Assessment (MNA) Scale: The MNA, at baseline and at four month intervals, is a validated nutrition screening and assessment tool that can identify patients at risk of malnutrition. The MNA was developed nearly 20 years ago and is the most well validated nutrition screening tool (Vellas, et al., 2006). There is a long and a short form. We will use the long form to more readily distinguish among levels of nutrition as opposed to just identifying those who are malnourished. It has been well validated in multiple populations and clinical settings (Bastiaanse, et al., 2011).

Scores on the Behavior and Symptom Identification Scale (BASIS-24): The BASIS-24 is a 24 item patient self-report questionnaire designed to assess treatment outcomes by measuring symptoms and functional difficulties experienced by patients seeking mental health services. Items are scored using a weighted average algorithm that gives an overall score and scores for six subscales: Depression and Functioning, Relationships, Self-Harm, Emotional Liability, Psychosis, and Substance Abuse. All items are answered on a 5 point scale.

The degree to which the illness restricts activities will be assessed between groups.

Waist circumference (WC) is measured in cm.

Basal Metabolic Index (BMI) is measured in kg/m2.

Blood pressure (BP) is measured in mmHg.

Heart rate is measured in beats per minute.

Respiration is measured in breaths per minute.