Use of the Functioning Assessment Short Test (FAST) in defining functional recovery in bipolar I disorder. Post-hoc analyses of long-term studies of aripiprazole once monthly as maintenance treatment

Figures & data

Figure 1 Study design. (A) Randomized-withdrawal study (Calabrese et al, 2017)⁷, (B) open-label maintenance study (Calabrese et al, 2018a).⁸

Abbreviation: AOM 400, Aripiprazole 400mg once-monthly.

Figure 2 FAST recovery rates after long-term treatment with AOM 400 or placebo.

Abbreviations: FAST, Functioning Assessment Short Test; AOM 400, Aripiprazole 400 mg once monthly.

Table 1 FAST scores at baseline and Week 52 of each study (LOCF)

	Randomized-withdrawal study			Open-label AOM 400 maintenance study
	AOM 400	Placebo	Treatment effect (AOM vs placebo); LS mean [95% CI]	De novo	Rollover
Autonomy score
Total population
Baseline; mean (SD)	1.47 (2.07)	1.35 (2.10)	−0.67 [−1.35,0.02]	1.23 (1.89)	1.19 (2.07)
Week 52; mean (SD)	1.72 (2.49)	2.43 (3.19)	P=0.055	1.19 (1.46)	1.46 (2.27)
Recovery population
Baseline; mean (SD)	0.29 (0.63)	0.04 (0.19)	0.01 [−0.23,0.24]	0.28 (0.79)	0.26 (0.78)
Week 52; mean (SD)	0.17 (0.45)	0.11 (0.42)	P=0.958	0.24 (0.60)	0.34 (0.94)
Occupational functioning score
Total population
Baseline; mean (SD)	5.73 (4.91)	5.69 (5.35)	−0.82 [−1.88,0.24]	4.69 (4.69)	4.42 (5.18)
Week 52; mean (SD)	5.29 (4.91)	6.39 (5.54)	P=0.128	4.50 (4.69)	5.05 (5.26)
Recovery population
Baseline; mean (SD)	2.26 (2.74)	1.56 (1.89)	0.24 [−0.63,1.11]	1.15 (1.85)	0.97 (1.32)
Week 52; mean (SD)	1.14 (1.65)	0.93 (1.59)	P=0.582	1.04 (1.83)	0.91 (1.38)
Cognitive functioning score
Total population
Baseline; mean (SD)	3.28 (3.38)	2.91 (3.18)	−0.56 (−1.44,0.32]	2.97 (2.99)	2.69 (3.20)
Week 52; mean (SD)	3.64 (3.62)	4.21 (4.06)	P=0.212	2.00 (3.14)	2.86 (3.42)
Recovery population
Baseline; mean (SD)	0.97 (1.57)	0.96 (1.29)	0.32 [−0.12,0.76]	1.14 (1.38)	0.97 (1.67)
Week 52; mean (SD)	0.66 (1.21)	0.29 (0.66)	P=0.155	0.96 (1.42)	0.86 (1.50)
Financial issues score
Total population
Baseline; mean (SD)	1.20 (1.66)	1.17 (1.48)	−0.35 [−0.74,0.04]	1.17 (1.59)	0.93 (1.40)
Week 52; mean (SD)	1.16 (1.53)	1.57 (1.72)	P=0.075	1.09 (1.58)	1.09 (1.49)
Recovery population
Baseline; mean (SD)	0.32 (0.68)	0.57 (1.23)	−0.06 [−0.49,0.36]	0.40 (0.90)	0.31 (0.76)
Week 52; mean (SD)	0.29 (0.83)	0.43 (0.88)	P=0.777	0.41 (0.95)	0.31 (0.76)
Interpersonal relationships score
Total population
Baseline; mean (SD)	2.84 (3.50)	2.45 (2.87)	−1.32 [−2.32,-0.31]	2.75 (3.33)	2.52 (3.38)
Week 52; mean (SD)	3.15 (3.82)	4.50 (4.67)	P=0.011	2.71 (3.63)	2.33 (3.62)
Recovery population
Baseline; mean (SD)	1.15 (1.62)	0.71 (1.01)	0.17 [−0.37,0.70]	0.67 (1.09)	0.66 (1.21)
Week 52; mean (SD)	0.77 (1.26)	0.46 (0.79)	P=0.537	0.50 (1.01)	0.63 (1.03)
Leisure time score
Total population
Baseline; mean (SD)	1.40 (1.57)	1.18 (1.28)	−0.19 (−0.58,0.20)	1.27 (1.44)	1.14 (1.40)
Week 52; mean (SD)	1.62 (1.65)	1.81 (1.76)	P=0.339	1.45 (1.62)	1.16 (1.45)
Recovery population
Baseline; mean (SD)	0.47 (1.08)	0.50 (0.64)	−0.00 [−0.38,0.38]	0.46 (0.78)	0.54 (0.89)
Week 52; mean (SD)	0.49 (0.92)	0.54 (0.69)	P=0.992	0.44 (0.86)	0.49 (0.82)

Table S1 The Functioning Assessment Short Test (FAST)

Physician rates each item according to difficulty:
(0) None (1) mild (2) moderate (3) severe
AUTONOMY 1. Taking responsibility for a household 2. Living on your own 3. Doing shopping 4. Taking care of yourself (physical aspects, hygiene)	FINANCIAL ISSUES 15. Managing your own money 16. Spending money in a balanced way
OCCUPATIONAL FUNCTIONING 5. Holding down a paid job 6. Accomplishing tasks as quickly as necessary 7. Working in the field in which you were educated 8. Occupational earnings 9. Managing the expected workload	INTERPERSONAL RELATIONSHIPS 17. Maintaining a friendship or friendships 18. Participating in social activities 19. Having good relationships with people close to you 20. Living together with your family 21. Having satisfactory sexual relationships 22. Being able to defend you interests
COGNITIVE FUNCTIONING 10. Ability to concentrate on a book, film 11. Ability to make mental calculations 12. Ability to solve a problem adequately 13. Ability to remember newly-learned names 14. Ability to learn new information	LEISURE TIME 23. Doing exercise or participating in sport 24. Having hobbies or personal interests

Note: Data from Rosa et al (2007).¹⁰

Table S2 List of institutional review boards (IRB) and/or independent ethics committees (IEC)

Local or central IRB/IEC	IRB/IEC Name
Placebo-controlled, double-blind, randomized-withdrawal study
Central IRB - Canada	Schulman Associates Institutional Review Board, 4445 Lake Forest Drive, Suite 300, Cincinnati, Ohio 45242
Local IRB - Japan	Yuge Hospital Institutional Review Board, 679-2 Yuge, Tatsuda-machi, Kita-ku, Kumamoto prefecture 861-8002, Japan
	Arakaki Hospital Institutional Review Board, 4-10-3 Ageda, Okinawa, 904- 0012, Japan
	South Toyama Nakagawa Institutional Review Board 146 Omachi, Toyama city, Toyama prefecture, 939-8073, Japan
	NHO Tottori Medical Center Institutional Review Board 876 Mitsu, NHO Tottori Medical Center, Tottori city, Tottori prefecture, 689-0203, Japan
	Goryokai Medical Corporation Institutional Review Board 6-2-3 9-jo, Shinoro, Kita-ku, Sapporo city 002-8029, Hokkaido, Japan
	Asai Clinic Institutional Review Board, 1-14 Katabira-cho, Hodogaya-ku, Yokohama 240-0013, Kanagawa, Japan
	Asakayama General Hospital Institutional Review Board 3-3-16 Imaike-cho, Sakai-ku, Sakai city 590-0018, Osaka, Japan
	Japan Nara Medical University Masatoshi Hasegawa, 840 Shijo-cho, Kashihara 634- 8522, Nara, Japan
	Hoshi General Hospital Institutional Review Board 159-1 Mukaikawara-machi, Koriyama 963-8501, Fukushima, Japan
	Shinagawa East One Medical Clinic Institutional Review Board 2-16-1, Konan Minato-ku, Tokyo 108-0075, Japan
	Seiwakai Medical Corporation Association Yutaka Clinic Institutional Review Board 3-14-20 Sagamiono, Minami-ku, Sagamihara-shi 252-0303, Kanagawa, Japan
	Tokyo Women’s Medical University Institutional Review Board, 8-1 Kawada-cho, Shinjyuku-ku 162-8666, Tokyo, Japan
	Medical Corporation Kyouwakai, Hannan Hospital Institutional Review Board, 277, Handa Minamino-cho, Naka-ku, Sakai 599-8263, Osaka, Japan
	Medical Corporation Houmankai Umezu Clinic Institutional Review Board, 2-6-12 Harada, Chikushino 818- 0024, Fukuoka, Japan
	Takeda General Hospital Institutional Review Board 3-27 Yamagamachi, Aizu Wakamatsu 965-8585, Fukushima, Japan
	Fukuoka University Hospital Institutional Review Board 7-45-1 Nanakuma, Jyonan-ku, Fukuoka-shi 814-0180, Fukuoka, Japan
	Japan Iwate Medical University Toru Sugiyama, 19-1m Uchimaru, Morioka-shi 020-8505, Iwate, Japan
	National Hospital Organization Hizen Psychiatric Center Institutional Review Board 160, Mitsu, Yoshinogari-cho, Kanzaki-gun 842-0192, Saga, Japan
	Nagasaki Medical Center of Psychiatry Institutional Review Board, 1575-2 Seibu Machi, Omura 856- 0847, Nagasaki, Japan
Central IRB - Poland	Komisja Bioetyczna przy Bydgoskiej lzbie Lekarskiej ul. Powstadcow Warszawy 1 1 85-681 Bydgoszcz
Central IRB - Romania	Comisia Nationala de Etica pentru Studiul Clinic al Medicamentului, Str. Av. Sanatescu nr.48 Sector I Bucuresti
Local IRB - South Korea	Institutional Review Board of The Catholic University of Korea 10, 63-ro, Yeongdeungpo-gu, 150-713, Republic of Korea
	Institutional Review Board of Eulji General Hospital, 68, Hangeulbiseok-ro, Nowon- gu, Seoul, 139-711 Republic of Korea
	Institutional Review Board of Jeju National University Hospital Aran 13gil 15, Jeju-si, Jeju Special Self-Governing Province, 690-767, Republic of Korea
	Chungnam National University Hospital, 282, Munhwa-ro, Jung-gu, Daejeon, 30”1-721, Republic of Korea
	Institutional Review Board of Korea University Anam Hospital 73 Inchon-ro, Seongbuk-Gu, Seoul, 136-705, Republic of Korea
	Institutional Review Board of Dongguk University Ilsan Hospital, 27 Dongguk-rom, Ilsandong-gu, Goyang-si, 410-773, Republic of Korea, Site 255
	Institutional Review Board of Hallym University Sacred Heart Hospital, 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 431-070, Republic of Korea
Local IRB - Taiwan	Taipei City Hospital Institutional Review Board, No. 145, Zhengzhou Road, Taipei City, 103 Taiwan
	Chang Gung Medical Foundation Institutional Review Board No. 199, Tunhua North Road, Taipei City, 105 Taiwan
Central IRB - United States	Schulman Associates Institutional Review Board, 4445 Lake Forest Drive, Suite 300, Cincinnati, Ohio 45242
Local IRB - United States	UC Irvine: Office of Research Institutional Review Board 5171 California, Suite 150, Irvine, California 92697
	United States University at Buffalo: Health Ron Moscati Site 024 Sciences Institutional Review Board, 875 Ellicott Street, Buffalo, New York 14203
	Western Institutional Review Board, 3535 7th Avenue SW, Olympia, Washington 98502
	Louisiana State University Health Sciences Institutional Review Board, 433 Bolivar Street Suite 206, New Orleans, Louisiana 70112
Open-label study
Central IRB USA	Schulman Associates Institutional Review Board, 4445 Lake Forest Drive Suite 300, Cincinnati, Ohio 45242 USA
Central IRB Canada Sites	Schulman Associates Institutional Review Board, 4445 Lake Forest Drive Suite 300, Cincinnati, Ohio 45242 USA
Central IRB France	Comité de Protection des Personnes Ile de France XI, Pavillon Jacques Courtois - 2ème étage, 20, rue Armagis 78105 Saint Germain en Laye Cedex
Central IRB Hungary	Medical Research Council Ethics Committee of Clinical Pharmacology, (Egészségügyi Tudományos Tanács Klinikai Farmakológiai Etikai Bizottsága), 1051 Budapest Arany János str. 6-8.
Local IRB Japan	Yuge Hospital Institutional Review Board 679-2 Yuge, Tatsuda-machi, Kita-ku, Kumamoto-city, Kumamoto, 861-8002, Japan
	Goryokai Medical Corporation Institutional Review Board, 6-2-3 9-jo, Shinoro, Kita-ku, Sapporo-shi, 002- 8029, Hokkaido, Japan
	Seiwakai Medical Corporation Association Yutaka Clinic Institutional Review Board 3-14-20 Sagamiono, Minami-ku, Sagamihara- shi 252-0303, Kanagawa, Japan
	Unokai Medical Corporation Arakaki Hospital Institutional Review Board, 4-10-3 Ageda, Okinawa-city, 904-0012, Okinawa, Japan
	Medical Corporation Houmankai Umezu Clinical Institutional Review Board, 2-6-12 Harada, Chikushino-shi, 818-0024, Fukuoka, Japan
	Fukuoka University Hospital Institutional Review Board, 7-45-1 Nanakuma, Jyonan-ku, Fukuoka-shi, 814-0810, Fukuoka, Japan
	Nagano Red Cross Hospital Institutional Review Board, 5-22-1, Wakasato, Nagano-shi, 380-8582, Nagano-ken, Japan
	Shin Nihonbashi Ishii Clinic Institutional Review Board, 3rd Floor, Shin-Edobashi Building 8-6, Kobuna-cho, Nihonbashi, Chuo-ku, 103-0024, Tokyo, Japan
	National Hospital Organization Mito Medical Center Institutional Review Board. 280 Sakuranosato, Ibarakimachi, Higashiibaraki-gun, 311-3193, Ibaraki, Japan
	Clinical Corporation Ikuseikai Shinozuka Institutional Review Board, 105-1 Shinozuka, Fujioka-shi, 375-0017, Gunma, Japan
	Aino Clinic Institutional Review Board Osakaekimaedaisan Building 18F, 1-1-3-1800, Umeda, Kita-ku, Osaka-city, 530-0001, Osaka, Japan
	Shoda Hospital Institutional Review Board 1-16-32 Annaka, Annaka-shi, 379-0116, Gunma, Japan
	Asai Dermatology Clinic Institutional Review Board, 1-14 Katabiracho, Hodogaya-ku, Yokohama, 240-0013, Kanagawa, Japan
	Seiwakai Medical Corporation Association Yutaka Clinic Institutional Review Board 3rd Floor, 3-14-20, Sagamiono, Minami-ku, Sagamihara, 252-0303, Kanagawa, Japan
	Sugiura Clinic Medical Corporation Institutional Review Board, 4-4-16-301 Honmachi, Kawaguchi-shi, 332- 0012, Saitama, Japan
	Nanko Kokoro no Clinic Institutional Review Board, 33 Sekibehikimebashi, Shirakawa, 962-0021, Fukushima, Japan
	Shin-Abuyama Hospital Institutional Review Board, 4-10-1 Nasahara, Takatsuki, Osaka-city, 569- 1041, Osaka, Japan
	Okayama Psychiatric Medical Center Institutional Review Board, 3-16 Shikatahonmachi, Kita-ku, Okayama-shi, 700-0915, Okayama, Japan
	St. Marianna University Group Institutional Review Board, 2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, 216-8511, Kanagawa, Japan
	National Center of Neurology and Psychiatry (NCNP) Institutional Review Board, 4-1-1 Ogawahigashi-cho, Asahi-ku, Kodaira- shi, 187-8551, Tokyo, Japan
	Nanbu Medical Center/Children Medical Center Institutional Review Board Arakawa 118-1, Haebarucho, Shimajirigun, 901-1193, Okinawa, Japan
	Kochi Medical School Hospital Institutional Review Board, Kohasu Oko-cho, Nankoku, 783-8505, Kochi, Japan
	Kondo Hospital Institutional Review Board 4-114 Showa-dori, Amagasaki-shi 660-0881, Hyogo, Japan
	Himorogi Psychiatric Institute, Medical Corporation Jisenkai Institutional Review Board, 2-31-3 Ichigaya Tamachi, Shinjuku-ku, 162- 0843, Tokyo, Japan
	Arakaki Hospital Institutional Review Board 4-10-3 Ageda, Okinawa-shi, 904-0012, Okinawa, Japan
	Medical Corporation YUSHINKAI Yushinkai Clinic Institutional Review Board, 2-12-12 Shinmori, Asahi-ku, Osaka-shi, 535- 0022, Osaka, Japan
	Okitama Public General Hospital Institutional Review Board, 2000 NishiOtsuka, Kawanishimachi, HigashiOkitamagun, 992-0601, Yamagata, Japan
	Osaka City University Hospital Institutional Review Board, 1-5-7 Asahimachi, Abenoku, Osaka-city, 545- 8586, Osaka, Japan
	Nishi Hospital Institutional Review Board 3-2-18 Bingo-cho, Nada-ku, Kobe, 657-0037, Hyogo, Japan
Central IRB Malaysia	Medical Research & Ethics Committee (Health Ministry), Institut Pengurusan Kesihatan, Jalan Rumah Sakit, Bangsar, 59000 Kuala Lumpur Malaysia
Central IRB Poland	Bioethics Committee at the Regional Medical Chamber in Bydgoszcz (Komisja Bioetyczna przy Okręgowej Izbie Lekarskiej w Bydgoszczy), ul. Powstańców Warszawy 11, 85-681 Bydgoszcz
Central IRB Romania	The National Bioethics Committee for Medicines and Medical Devices Soseaua Stefan cel Mare no. 19-21 SECTOR 2 BUCHAREST 020125
Local IRB South Korea	Eulji General Hospital IRB, 68, Hangeulbiseok-ro, Nowon-gu, Seoul, 139- 711, Republic of Korea
	Jeju National University Hospital IRB Aran 13gil 15, Jeju-si, Jeju Special Self- Governing Province, 690-767, Republic of Korea
	Korea University Anam Hospital IRB, 73, Inchon-ro, Seongbuk-gu, Seoul, 136-705, Republic of Korea
	Dongguk University Ilsan Hospital IRB, 27, Dongguk-ro, Ilsandong-gu, Goyang-si, 410-773, Republic of Korea
Local IRB Taiwan	Taipei City Hospital Research Ethics Committee, Taipei, Taiwan
Local IRB United States	RGHS Clinical Investigation Committee 1425 Portland Ave, Rochester, NY 14621
	Northwestern University Institutional Review Board, Rubloff Building, 7th Floor, 750 N. Lake Shore Dr. Chicago, IL 60611
	Dean Institutional Review Board, 2711 Allen Boulevard, Suite 300, Middleton, Wisconsin, 53562
	UB Institutional Review Board, 800 University Bay Drive, Suite 105 Madison, WI 53705

Calabrese JR, Sanchez R, Jin N, et al. Efficacy and safety of aripiprazole once-monthly in the maintenance treatment of bipolar I disorder: a double-blind, placebo-controlled, 52-week randomized withdrawal study. J Clin Psychiatry. 2017;78(3):324–331. doi:10.4088/JCP.16m1120128146613

 PubMed Web of Science ®Google Scholar

Calabrese JR, Jin N, Johnson B, et al. Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study. Int J Bipolar Disord. 2018;6(1):14. doi:10.1186/s40345-018-0122-z29886522

 PubMed Web of Science ®Google Scholar

Rosa AR, Sanchez-Moreno J, Martinez-Aran A, et al. Validity and reliability of the Functioning Assessment Short Test (FAST) in bipolar disorder. Clin Pract Epidemiol Ment Health. 2007;3:5. doi:10.1186/1745-0179-3-517555558

 PubMedGoogle Scholar